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2. Non‐invasive vagus nerve stimulation to reduce ileus after colorectal surgery: randomized feasibility trial and efficacy assessment (IDEAL Stage 2B).

Author

Chapman, Stephen J., Kowal, Mikolaj, Helliwell, Jack A., Lockwood, Sonia, Naylor, Maureen, Croft, Julie, Farley, Katherine, Stocken, Deborah D., and Jayne, David G.

Abstract

Aim: Ileus is characterized by a period of intestinal dysmotility after surgery, leading to vomiting and constipation. In preclinical models, vagus nerve stimulation reduces intestinal inflammation and prevents smooth muscle dysfunction, accelerating the return of gut function. This study explored the feasibility of a definitive trial of non‐invasive vagus nerve stimulation (nVNS) along with an early assessment of efficacy. Method: A multicentre, randomized feasibility trial (IDEAL Stage 2B) of self‐administered nVNS was performed. Patients undergoing colorectal surgery were randomized to nVNS or sham before and after surgery. Feasibility outcomes comprised assessments of recruitment, compliance, blinding and attrition. Clinical outcomes were measures of intestinal function and adverse events. All participants were followed up for 30 days. Interviews with patients and health professionals explored barriers to feasibility and perspectives around implementation. Results: In all, 125 patients were approached about the study and 97 (77.6%) took part. Across all randomized groups, the median compliance to treatment was 19 out of 20 stimulations (interquartile range 17–20). The incidence of adverse events was similar across groups. In this unpowered feasibility study, the time taken for the return of gut function (such as first passage of stool) was similar between nVNS and sham treatments. According to interviews, patients were highly motivated to use the device because it provided them with an opportunity to engage actively in their care. Health professionals were highly driven to tackle the problem of ileus. Conclusion: Powered assessments of clinical efficacy are required to confirm or refute the promise of nVNS, as already demonstrated in preclinical models. This feasibility study concludes that a definitive randomized assessment of the clinical benefits of nVNS is desired and feasible. [ABSTRACT FROM AUTHOR]

Published
2024
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5. Tolerating Subretinal Fluid in Neovascular Age-Related Macular Degeneration Treated with Ranibizumab Using a Treat-and-Extend Regimen: FLUID Study 24-Month Results

Author

Chang, Andrew, Syed, Adil, Broadhead, Geoffrey, Pham, Thomas, Hong, Thomas, Wong, Lily, Zhu, Meidong, Burnett, Shelley, Joachim, Nichole, Wijeyakumar, Wijeyanthy, Manalang, Gabriel, Mhlanga, Cleopatra, Joachim, Nicole, Spooner, Kimperly, Mitchell, Paul, Foran, Suriya, Wilson, Christabel, Cossatto, Victoria, Waniganayke, Laskshmi, Mai, Vivien, Atif, Rabiya, Wa, Lakshmi, Maharaj, Sapna, Liong, David, Matic, Christine, Tran, Katherine, Jas, Sheenal, Gibbs, Danielle, Wickremasinghe, Sanj, Guymer, Robyn, Lim, Lyndell, Sandhu, Sukhpal, Nguyen, Thanh, Qatarneh, Dania, Razavi, Hessom, Chong, Elaine, Little, Matthew, Bhardwau, Gaurav, Ayres, Michael, Chen, Michael, Ong, Daini, Creese, Katarina, Drew, Tricia, D'Sylva Parfett, Carly, Pejnovic, Tanya, Chau, Thuy, Sanmugasundram, Sutha, Kolic, Maria, Glatz, Elizabeth, Tonder, Tina-Marie, Luckie, Alan, Heery, Stephen, Steele, Timothy, Arnold, Jennifer, Matthews, Bryan, Croft, Julie, Breen, Alex, Gabriel, Bronwyn, Anderson, Maegan, Dodds, Michelle, Dwyer, Marcus, Brown, Bev, Dwyer, Jacinta, Fu, Ivan, Macauley, Helen, Wong, James, Chalasani, Rajeev, Lim, Charmaine, Huynh, Son, Nolan, Timothy, Leong, James, Lau, Kit, Kumar, Swas, Nguyen, Trang, Bitar, Joseph, Ahern, Hannah, Ali, Arooj, Zamora, Nuria, Lai, Angela, Moussa, Randa, Do, Carmen, Verma, Nitin, Bylsma, Guy, Traill, Andrew, Curry, Beverley, Paprotny, Amy, Ayesa, Alfonso, Johns, Alyse, Ujjainwala, Zanobia, Maver, Andrew, Chan, Derek, Chang, John, Kang, Hyong Kwon, Stringfellow, Gavin, Tan, Terence, Cass, Helen, Forsyth, Trish, Nguyen, Anh, Chung, Angela, Ayson, Harriette, Severino, Catherine, Chahine, Caroline, Collis, Lara, Cristy, Anita, Mohmodian, Mona, Webb, Selina, Payir, Muradiya, Garibaldi, Mara, Mekhail, Trazia, Vote, Brendan, Toh, Tze'Yo, Pakrou, Nima, Rossetto, Jennie, Harris, Shannon, Adams, Rachael, Groves, Rachael, Johns, Maddie, Richards, Kristie, Jenkins, Eliza, Daley, Natalie, Baker, James, Gorbatov, Mark, Rajanayagam, Lavaniya, Jitskaia, Ludmila, Xie, Jenny, Nguyen, Anthony, McAllister, Ian, Chen, Fred, Isaacs, Tim, Dickens, Tracey-Anne, Matthews, Rachel, Jason, Amelia, Tang, Ivy, Lingham, Gareth, Brown, Holly, Soloshenko, Alla, Cuypers, Max, McSweeney, Anne, Gilhotra, Jolly, Durkin, Shane, Muecke, James, Haywood, Kerin, Brko, Cathy, Vincent, Rinty, Luscombe, Carolyn, Hunyor, Alex, Younan, Christine, Chong, Robert, Merani, Rohan, Fung, Adrian, Ho, I-Van, Liew, Gerald, Lee, Vinnci, Chan, Gerald, Liu, Sarah, Ganess, Tharini, Rajasundaran, Susanthy, Sadat, Maryam, Quin, Godfrey, Ong, Stephen, Hooper, Claire, Dihn, Vivien, Al-Ghurani, Ward, Ngai, Sally, Choi, Maria, Tisma, Gordana, Van Heerden, Anton, Hall, Anthony, Michalova, Kira, Coleman, Natalie, Price, Allanah, Nguyen, Mercy, Hanna, Clodia, Collins, Camille, Dickeson, Elaina, Lee, Annie, Bilyk, Mela, Lee, Theresa, Downie, John, Assaad, Naggi, Cooper, Leanne, Le, Catherine, Armanssen, Amanda, Khalil, Zena, Guymer, Robyn H., Markey, Caroline M., McAllister, Ian L., Gillies, Mark C., Hunyor, Alex P., and Arnold, Jennifer J.

Published
2019
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8. Posterior cervical foraminotomy versus anterior cervical discectomy for Cervical Brachialgia: the FORVAD RCT

Author

Thomson, Simon, primary, Ainsworth, Gemma, additional, Selvanathan, Senthil, additional, Kelly, Rachel, additional, Collier, Howard, additional, Mujica-Mota, Ruben, additional, Talbot, Rebecca, additional, Brown, Sarah Tess, additional, Croft, Julie, additional, Rousseau, Nikki, additional, Higham, Ruchi, additional, Al-Tamimi, Yahia, additional, Buxton, Neil, additional, Carleton-Bland, Nicholas, additional, Gledhill, Martin, additional, Halstead, Victoria, additional, Hutchinson, Peter, additional, Meacock, James, additional, Mukerji, Nitin, additional, Pal, Debasish, additional, Vargas-Palacios, Armando, additional, Prasad, Anantharaju, additional, Wilby, Martin, additional, and Stocken, Deborah, additional

Published
2023
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10. Clinical and cost-effectiveness of PCF versus ACD in the treatment of cervical brachialgia (FORVAD trial).

Author

Thomson, Simon, Ainsworth, Gemma, Selvanathan, Senthil, Brown, Sarah, Croft, Julie, Kelly, Rachel, Mujica-Mota, Ruben, Rousseau, Nikki, Higham, Ruchi, and Stocken, Deborah

Subjects
PATIENT reported outcome measures, COST effectiveness, NECK pain, RADICULOPATHY
Abstract

Cervical radiculopathy occurs when a nerve root is compressed in the spine, if symptoms fail to resolve after 6 weeks surgery may be indicated. Anterior Cervical Discectomy (ACD) is the commonest procedure, Posterior Cervical Foraminotomy (PCF) is an alternative that avoids the risk of damage to anterior neck structures. This prospective, Phase III, UK multicentre, open, individually randomised controlled trial was performed to determine whether PCF is superior to ACD in terms of improving clinical outcome as measured by the Neck Disability Index (NDI) 52 weeks post–surgery. Following consent to participate and collection of baseline data, subjects with cervical brachialgia were randomised to ACD or PCF in a 1:1 ratio on the day of surgery. Clinical outcomes were assessed on day 1 and patient reported outcomes on day 1 and weeks 6, 12, 26, 39 and 52 post-operation. A total of 252 participants were planned to be randomised. Statistical analysis was limited to descriptive statistics. Health economic outcomes were also described. The trial was closed early (n = 23). Compared to baseline, the median (interquartile range (IQR)) NDI score at 52 weeks reduced from 44.0 (36.0, 62.0) to 25.3 (20.0, 42.0) in the PCF group and increased from 35.6 (34.0, 44.0) to 45.0 (20.0, 57.0) in the ACD group. ACD may be associated with more swallowing, voice and other complications and was more expensive; neck and arm pain scores were similar. The trial was closed early, therefore no definitive conclusions on clinical or cost-effectiveness could be made. [ABSTRACT FROM AUTHOR]

Published
2024
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11. Pathway Of Low Anterior Resection syndrome relief after Surgery (POLARiS) feasibility trial protocol: a multicentre, feasibility cohort study with embedded randomised control trial to compare sacral neuromodulation and transanal irrigation to optimised conservative management in the management of major low anterior resection syndrome following rectal cancer treatment

Author

Coxon-Meggy, Alexandra Harriet, primary, Vogel, Irene, additional, White, Judith, additional, Croft, Julie, additional, Corrigan, Neil, additional, Meggy, Alun, additional, Stocken, Deborah D, additional, Keller, Deborah, additional, Hompes, Roel, additional, Knowles, Charles H, additional, Quyn, Aaron, additional, and Cornish, Julie, additional

Published
2023
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12. Recruiting to surgical trials in the emergency setting: using a mixed methods study to understand clinician and patient perspectives

Author

Twiddy, Maureen, primary, Birtwistle, Jacqueline, additional, Edmondson, Amanda, additional, Croft, Julie, additional, Gordon, Kathryn, additional, Meads, David, additional, Burke, Dermot, additional, Griffiths, Ben, additional, Rose, Azmina, additional, Sagar, Peter, additional, Stocken, Deborah, additional, Brown, Julia M B, additional, and Harji, Deena, additional

Published
2022
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15. Effect of Robotic-Assisted vs Conventional Laparoscopic Surgery on Risk of Conversion to Open Laparotomy Among Patients Undergoing Resection for Rectal Cancer: The ROLARR Randomized Clinical Trial

Author

Jayne, David, Pigazzi, Alessio, Marshall, Helen, Croft, Julie, Corrigan, Neil, Copeland, Joanne, Quirke, Phil, West, Nick, Rautio, Tero, Thomassen, Niels, Tilney, Henry, Gudgeon, Mark, Bianchi, Paolo Pietro, Edlin, Richard, Hulme, Claire, and Brown, Julia

Published
2017
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16. Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously

Author

Parker, Adwoa, primary, Arundel, Catherine, additional, Mills, Nicola, additional, Rooshenas, Leila, additional, Jepson, Marcus, additional, Donovan, Jenny L, additional, Blazeby, Jane M, additional, Coleman, Elizabeth, additional, Clark, Laura, additional, Doherty, Laura, additional, Hewitt, Catherine E, additional, Partha Sarathy, Prasanna, additional, Beard, David, additional, Bower, Peter, additional, Brealey, Stephen, additional, Brocklehurst, Paul, additional, Cooper, Cindy, additional, Croft, Julie, additional, Culliford, Lucy, additional, Dias, Joseph, additional, Devane, Declan, additional, Eldridge, Sandra, additional, Emsley, Richard, additional, Galvin, Sandra, additional, Gemperle-Mannion, Elke, additional, Jayne, David G, additional, Metcalfe, Andrew J, additional, Montgomery, Alan, additional, Rangan, Amar, additional, Sutton, Christopher J, additional, Tharmanathan, Puvanendran, additional, Treweek, Shaun, additional, and Torgerson, David, additional

Published
2022
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17. Clinical and cost-effectiveness of Knee Arthroplasty versus Joint Distraction for Osteoarthritis (KARDS): protocol for a multicentre, phase III, randomised control trial

Author

Tassinari, Cerys Joyce, primary, Higham, Ruchi, additional, Smith, Isabelle Louise, additional, Arnold, Susanne, additional, Mujica-Mota, Ruben, additional, Metcalfe, Andrew, additional, Simpson, Hamish, additional, Murray, David, additional, McGonagle, Dennis G, additional, Sharma, Hemant, additional, Hamilton, Thomas William, additional, Ellard, David R, additional, Fernandez, Catherine, additional, Reynolds, Catherine, additional, Harwood, Paul, additional, Croft, Julie, additional, Stocken, Deborah D, additional, and Pandit, Hemant, additional

Published
2022
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18. Staff training to improve participant recruitment into surgical randomised controlled trials: A feasibility study within a trial (SWAT) across four host trials simultaneously

Author

Parker, Adwoa, Arundel, Catherine, Mills, Nicola, Rooshenas, Leila, Jepson, Marcus, Donovan, Jenny L, Blazeby, Jane M, Coleman, Elizabeth, Clark, Laura, Doherty, Laura, Hewitt, Catherine E, Partha Sarathy, Prasanna, Beard, David, Bower, Peter, Brealey, Stephen, Brocklehurst, Paul, Cooper, Cindy, Croft, Julie, Culliford, Lucy, Dias, Joseph, Devane, Declan, Eldridge, Sandra, Emsley, Richard, Galvin, Sandra, Gemperle-Mannion, Elke, Jayne, David G, Metcalfe, Andrew J, Montgomery, Alan, Rangan, Amar, Sutton, Christopher J, Tharmanathan, Puvanendran, Treweek, Shaun, and Torgerson, David

Abstract

Objective To test the feasibility of undertaking a simultaneous Study Within A Trial (SWAT) to train staff who recruit participants into surgical randomised controlled trials (RCTs), by assessing key uncertainties around recruitment, randomisation, intervention delivery and data collection.Study design and setting Twelve surgical RCTs were eligible. Interested sites (clusters) were randomised 1:1, with recruiting staff (surgeons and nurses) offered training or no training. The primary outcome was the feasibility of recruiting sites across multiple surgical trials simultaneously. Secondary outcomes included numbers/types of staff enrolled, attendance at training, training acceptability, confidence in recruiting and participant recruitment rates six months later.Results Four RCTs (33%) comprising 91 sites participated. Of these, 29 sites agreed to participate (32%) and were randomised to intervention (15 sites, 29 staff) or control (14 sites, 29 staff). Research nurses attended and found the training to be acceptable; no surgeons attended. In the intervention group, there was evidence of increased confidence when pre- and post- training scores were compared (mean difference in change 1.42; 95% CI 0.56, 2.27; p= 0.002). There was no effect on recruitment rate.Conclusion It was feasible to randomise sites across four surgical RCTs in a simultaneous SWAT design. However, as small numbers of trials and sites participated, and no surgeons attended training, strategies to improve these aspects are needed for future evaluations.

Published
2023
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19. Liver resection surgery compared with thermal ablation in high surgical risk patients with colorectal liver metastases: the LAVA international RCT

Author

Davidson, B.R., Gurusamy, Kurinchi, Corrigan, Neil, Croft, Julie, Ruddock, S., Pullan, Alison, Laarhoven, K. van, Wilt, J.H.W. de, Davidson, B.R., Gurusamy, Kurinchi, Corrigan, Neil, Croft, Julie, Ruddock, S., Pullan, Alison, Laarhoven, K. van, and Wilt, J.H.W. de

Abstract

Contains fulltext : 218983.pdf (publisher's version ) (Open Access)

Published
2020

20. Sacral nerve stimulation versus the magnetic sphincter augmentation device for adult faecal incontinence: the SaFaRI RCT

Author

Jayne, David G, primary, Williams, Annabelle E, additional, Corrigan, Neil, additional, Croft, Julie, additional, Pullan, Alison, additional, Napp, Vicky, additional, Kelly, Rachel, additional, Meads, David, additional, Vargas-Palacios, Armando, additional, Martin, Adam, additional, Hulme, Claire, additional, Brown, Steven R, additional, Nugent, Karen, additional, Lodge, Jen, additional, Protheroe, David, additional, Maslekar, Sushil, additional, Clarke, Andrew, additional, Nisar, Pasha, additional, and Brown, Julia M, additional

Published
2021
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22. Liver resection surgery compared with thermal ablation in high surgical risk patients with colorectal liver metastases: the LAVA international RCT

Author

Davidson, Brian, primary, Gurusamy, Kurinchi, additional, Corrigan, Neil, additional, Croft, Julie, additional, Ruddock, Sharon, additional, Pullan, Alison, additional, Brown, Julia, additional, Twiddy, Maureen, additional, Birtwistle, Jaqueline, additional, Morris, Stephen, additional, Woodward, Nick, additional, Bandula, Steve, additional, Hochhauser, Daniel, additional, Prasad, Raj, additional, Olde Damink, Steven, additional, Coolson, Marielle, additional, Laarhoven, K van, additional, and de Wilt, Johannes HW, additional

Published
2020
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25. Tolerating Subretinal Fluid in Neovascular Age-Related Macular Degeneration Treated with Ranibizumab Using a Treat-and-Extend Regimen

Author

Guymer, Robyn H., primary, Markey, Caroline M., additional, McAllister, Ian L., additional, Gillies, Mark C., additional, Hunyor, Alex P., additional, Arnold, Jennifer J., additional, Chang, Andrew, additional, Syed, Adil, additional, Broadhead, Geoffrey, additional, Pham, Thomas, additional, Hong, Thomas, additional, Wong, Lily, additional, Zhu, Meidong, additional, Burnett, Shelley, additional, Joachim, Nichole, additional, Wijeyakumar, Wijeyanthy, additional, Manalang, Gabriel, additional, Mhlanga, Cleopatra, additional, Joachim, Nicole, additional, Spooner, Kimperly, additional, Mitchell, Paul, additional, Foran, Suriya, additional, Wilson, Christabel, additional, Cossatto, Victoria, additional, Waniganayke, Laskshmi, additional, Mai, Vivien, additional, Atif, Rabiya, additional, Wa, Lakshmi, additional, Maharaj, Sapna, additional, Liong, David, additional, Matic, Christine, additional, Tran, Katherine, additional, Jas, Sheenal, additional, Gibbs, Danielle, additional, Wickremasinghe, Sanj, additional, Guymer, Robyn, additional, Lim, Lyndell, additional, Sandhu, Sukhpal, additional, Nguyen, Thanh, additional, Qatarneh, Dania, additional, Razavi, Hessom, additional, Chong, Elaine, additional, Little, Matthew, additional, Bhardwau, Gaurav, additional, Ayres, Michael, additional, Chen, Michael, additional, Ong, Daini, additional, Creese, Katarina, additional, Drew, Tricia, additional, D'Sylva Parfett, Carly, additional, Pejnovic, Tanya, additional, Chau, Thuy, additional, Sanmugasundram, Sutha, additional, Kolic, Maria, additional, Glatz, Elizabeth, additional, Tonder, Tina-Marie, additional, Luckie, Alan, additional, Heery, Stephen, additional, Steele, Timothy, additional, Arnold, Jennifer, additional, Matthews, Bryan, additional, Croft, Julie, additional, Breen, Alex, additional, Gabriel, Bronwyn, additional, Anderson, Maegan, additional, Dodds, Michelle, additional, Dwyer, Marcus, additional, Brown, Bev, additional, Dwyer, Jacinta, additional, Fu, Ivan, additional, Macauley, Helen, additional, Wong, James, additional, Chalasani, Rajeev, additional, Lim, Charmaine, additional, Huynh, Son, additional, Nolan, Timothy, additional, Leong, James, additional, Lau, Kit, additional, Kumar, Swas, additional, Nguyen, Trang, additional, Bitar, Joseph, additional, Ahern, Hannah, additional, Ali, Arooj, additional, Zamora, Nuria, additional, Lai, Angela, additional, Moussa, Randa, additional, Do, Carmen, additional, Verma, Nitin, additional, Bylsma, Guy, additional, Traill, Andrew, additional, Curry, Beverley, additional, Paprotny, Amy, additional, Ayesa, Alfonso, additional, Johns, Alyse, additional, Ujjainwala, Zanobia, additional, Maver, Andrew, additional, Chan, Derek, additional, Chang, John, additional, Kang, Hyong Kwon, additional, Stringfellow, Gavin, additional, Tan, Terence, additional, Cass, Helen, additional, Forsyth, Trish, additional, Nguyen, Anh, additional, Chung, Angela, additional, Ayson, Harriette, additional, Severino, Catherine, additional, Chahine, Caroline, additional, Collis, Lara, additional, Cristy, Anita, additional, Mohmodian, Mona, additional, Webb, Selina, additional, Payir, Muradiya, additional, Garibaldi, Mara, additional, Mekhail, Trazia, additional, Vote, Brendan, additional, Toh, Tze'Yo, additional, Pakrou, Nima, additional, Rossetto, Jennie, additional, Harris, Shannon, additional, Adams, Rachael, additional, Groves, Rachael, additional, Johns, Maddie, additional, Richards, Kristie, additional, Jenkins, Eliza, additional, Daley, Natalie, additional, Baker, James, additional, Gorbatov, Mark, additional, Rajanayagam, Lavaniya, additional, Jitskaia, Ludmila, additional, Xie, Jenny, additional, Nguyen, Anthony, additional, McAllister, Ian, additional, Chen, Fred, additional, Isaacs, Tim, additional, Dickens, Tracey-Anne, additional, Matthews, Rachel, additional, Jason, Amelia, additional, Tang, Ivy, additional, Lingham, Gareth, additional, Brown, Holly, additional, Soloshenko, Alla, additional, Cuypers, Max, additional, McSweeney, Anne, additional, Gilhotra, Jolly, additional, Durkin, Shane, additional, Muecke, James, additional, Haywood, Kerin, additional, Brko, Cathy, additional, Vincent, Rinty, additional, Luscombe, Carolyn, additional, Hunyor, Alex, additional, Younan, Christine, additional, Chong, Robert, additional, Merani, Rohan, additional, Fung, Adrian, additional, Ho, I-Van, additional, Liew, Gerald, additional, Lee, Vinnci, additional, Chan, Gerald, additional, Liu, Sarah, additional, Ganess, Tharini, additional, Rajasundaran, Susanthy, additional, Sadat, Maryam, additional, Quin, Godfrey, additional, Ong, Stephen, additional, Hooper, Claire, additional, Dihn, Vivien, additional, Al-Ghurani, Ward, additional, Ngai, Sally, additional, Choi, Maria, additional, Tisma, Gordana, additional, Van Heerden, Anton, additional, Hall, Anthony, additional, Michalova, Kira, additional, Coleman, Natalie, additional, Price, Allanah, additional, Nguyen, Mercy, additional, Hanna, Clodia, additional, Collins, Camille, additional, Dickeson, Elaina, additional, Lee, Annie, additional, Bilyk, Mela, additional, Lee, Theresa, additional, Downie, John, additional, Assaad, Naggi, additional, Cooper, Leanne, additional, Le, Catherine, additional, Armanssen, Amanda, additional, and Khalil, Zena, additional

Published
2019
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26. Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial

Author

Gurusamy, K., Corrigan, Neil, Croft, Julie, Twiddy, Maureen, Morris, S., Woodward, Nick, Laarhoven, C.J.H.M. van, Wilt, J.H.W. de, Brown, Julia, Davidson, B.R., Gurusamy, K., Corrigan, Neil, Croft, Julie, Twiddy, Maureen, Morris, S., Woodward, Nick, Laarhoven, C.J.H.M. van, Wilt, J.H.W. de, Brown, Julia, and Davidson, B.R.

Abstract

Contains fulltext : 190023.pdf (publisher's version ) (Open Access)

Published
2018

27. Radical Cystectomy Against Intravesical BCG for High-Risk High-Grade Nonmuscle Invasive Bladder Cancer: Results From the Randomized Controlled BRAVO-Feasibility Study.

Author

Catto, James W F, Gordon, Kathryn, Collinson, Michelle, Poad, Heather, Twiddy, Maureen, Johnson, Mark, Jain, Sunjay, Chahal, Rohit, Simms, Matt, Dooldeniya, Mohantha, Bell, Richard, Koenig, Phillip, Conroy, Samantha, Goodwin, Louise, Noon, Aidan P, Croft, Julie, Brown, Julia M, and BRAVO study group

Published
2021
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29. A realist process evaluation of robot-assisted surgery: integration into routine practice and impacts on communication, collaboration and decision-making

Author

Randell, Rebecca, primary, Honey, Stephanie, additional, Hindmarsh, Jon, additional, Alvarado, Natasha, additional, Greenhalgh, Joanne, additional, Pearman, Alan, additional, Long, Andrew, additional, Cope, Alexandra, additional, Gill, Arron, additional, Gardner, Peter, additional, Kotze, Alwyn, additional, Wilkinson, David, additional, Jayne, David, additional, Croft, Julie, additional, and Dowding, Dawn, additional

Published
2017
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31. Next Generation intraoperative Lymph node staging for Stratified colon cancer surgery (GLiSten): a multicentre, multinational feasibility study of fluorescence in predicting lymph node-positive disease

Author

Andrew, Helen, primary, Gossedge, Gemma, additional, Croft, Julie, additional, Corrigan, Neil, additional, Brown, Julia M, additional, West, Nicholas, additional, Quirke, Philip, additional, Tolan, Damian, additional, Cahill, Ronan, additional, and Jayne, David G, additional

Published
2016
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38. Additional file 1: of Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial

Author

Kurinchi Gurusamy, Corrigan, Neil, Croft, Julie, Twiddy, Maureen, Morris, Stephen, Woodward, Nick, Bandula, Steve, Hochhauser, Daniel, Napp, Vicky, Pullan, Alison, Jakowiw, Nicholas, Prasad, Raj, Damink, Steven, C. Van Laarhoven, Wilt, Johannes De, Brown, Julia, and Davidson, Brian

Subjects
3. Good health
Abstract

SPIRIT checklist. The completed SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist for this protocol indicating the section in which the issue was covered is indicated in the table. (DOC 128 kb)

39. Additional file 1: of Liver resection surgery versus thermal ablation for colorectal LiVer MetAstases (LAVA): study protocol for a randomised controlled trial

Author

Kurinchi Gurusamy, Corrigan, Neil, Croft, Julie, Twiddy, Maureen, Morris, Stephen, Woodward, Nick, Bandula, Steve, Hochhauser, Daniel, Napp, Vicky, Pullan, Alison, Jakowiw, Nicholas, Prasad, Raj, Damink, Steven, C. Van Laarhoven, Wilt, Johannes De, Brown, Julia, and Davidson, Brian

Subjects
3. Good health
Abstract

SPIRIT checklist. The completed SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) checklist for this protocol indicating the section in which the issue was covered is indicated in the table. (DOC 128 kb)

40. Liver resection surgery compared with thermal ablation in high surgical risk patients with colorectal liver metastases: the LAVA international RCT

Author

Julia Brown, Alison Pullan, Raj Prasad, Neil Corrigan, Jaqueline Birtwistle, Daniel Hochhauser, Maureen Twiddy, Julie Croft, K. van Laarhoven, Steven W.M. Olde Damink, Brian R. Davidson, Steve Bandula, Stephen Morris, Johannes Hw de Wilt, Sharon Ruddock, Kurinchi Selvan Gurusamy, Nick Woodward, Marielle Coolson, Davidson, Brian [0000-0002-9152-5907], Gurusamy, Kurinchi [0000-0002-0313-9134], Corrigan, Neil [0000-0002-1424-9830], Croft, Julie [0000-0001-7586-3394], Pullan, Alison [0000-0001-6060-9123], Brown, Julia [0000-0002-2719-7064], Twiddy, Maureen [0000-0002-3794-1598], Birtwistle, Jaqueline [0000-0002-6083-589X], Morris, Stephen [0000-0002-5828-3563], Woodward, Nick [0000-0002-9177-4292], Bandula, Steve [0000-0002-4558-288X], Hochhauser, Daniel [0000-0001-5522-9281], Prasad, Raj [0000-0001-6061-001X], Olde Damink, Steven [0000-0002-5202-9345], Coolson, Marielle [0000-0002-1608-6668], Laarhoven, K van [0000-0003-2166-7931], de Wilt, Johannes Hw [0000-0001-6773-9668], Apollo - University of Cambridge Repository, RS: NUTRIM - R2 - Liver and digestive health, Surgery, and MUMC+: MA Heelkunde (9)

Subjects
Male, LIVER, medicine.medical_treatment, Cost-Benefit Analysis, Psychological intervention, Pilot Projects, 030218 nuclear medicine & medical imaging, law.invention, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], 0302 clinical medicine, Randomized controlled trial, law, Risk Factors, 030212 general & internal medicine, Prospective Studies, Netherlands, Cost–benefit analysis, COST–BENEFIT ANALYSIS, NEOPLASM METASTASIS, Health Policy, Liver Neoplasms, ABLATION TECHNIQUES, Middle Aged, Clinical equipoise, TRIALS, Treatment Outcome, lcsh:R855-855.5, Radiological weapon, Female, radiofrequency ablation, Colorectal Neoplasms, Record linkage, Research Article, Adult, medicine.medical_specialty, lcsh:Medical technology, microwave, HEPATECTOMY, Minimisation (clinical trials), Disease-Free Survival, 03 medical and health sciences, All institutes and research themes of the Radboud University Medical Center, medicine, recruiting patients, cancer, Humans, therapy, business.industry, United Kingdom, Surgery, Quality of Life, Feasibility Studies, Hepatectomy, RANDOMISED CONTROLLED TRIAL, Neoplasm Recurrence, Local, business
Abstract

Although surgical resection has been considered the only curative option for colorectal liver metastases, thermal ablation has recently been suggested as an alternative curative treatment. There have been no adequately powered trials comparing surgery with thermal ablation.Main objective - to compare the clinical effectiveness and cost-effectiveness of thermal ablation versus liver resection surgery in high surgical risk patients who would be eligible for liver resection. Pilot study objectives - to assess the feasibility of recruitment (through qualitative study), to assess the quality of ablations and liver resection surgery to determine acceptable standards for the main trial and to centrally review the reporting of computed tomography scan findings relating to ablation and outcomes and recurrence rate in both arms.A prospective, international (UK and the Netherlands), multicentre, open, pragmatic, parallel-group, randomised controlled non-inferiority trial with a 1-year internal pilot study.Tertiary liver, pancreatic and gallbladder (hepatopancreatobiliary) centres in the UK and the Netherlands.Adults with a specialist multidisciplinary team diagnosis of colorectal liver metastases who are at high surgical risk because of their age, comorbidities or tumour burden and who would be suitable for liver resection or thermal ablation.Thermal ablation conducted as per local policy (but centres were encouraged to recruit within Cardiovascular and Interventional Radiological Society of Europe guidelines) versus surgical liver resection performed as per centre protocol.Pilot study - patients' and clinicians' acceptability of the trial to assist in optimisation of recruitment. Primary outcome - disease-free survival at 2 years post randomisation. Secondary outcomes - overall survival, timing and site of recurrence, additional therapy after treatment failure, quality of life, complications, length of hospital stay, costs, trial acceptability, and disease-free survival measured from end of intervention. It was planned that 5-year survival data would be documented through record linkage. Randomisation was performed by minimisation incorporating a random element, and this was a non-blinded study.In the pilot study over 1 year, a total of 366 patients with colorectal liver metastases were screened and 59 were considered eligible. Only nine participants were randomised. The trial was stopped early and none of the planned statistical analyses was performed. The key issues inhibiting recruitment included fewer than anticipated patients eligible for both treatments, misconceptions about the eligibility criteria for the trial, surgeons' preference for one of the treatments ('lack of clinical equipoise' among some of the surgeons in the centre) with unconscious bias towards surgery, patients' preference for one of the treatments, and lack of dedicated research nurses for the trial.Recruitment feasibility was not demonstrated during the pilot stage of the trial; therefore, the trial closed early. In future, comparisons involving two very different treatments may benefit from an initial feasibility study or a longer period of internal pilot study to resolve these difficulties. Sufficient time should be allowed to set up arrangements through National Institute for Health Research (NIHR) Research Networks.Current Controlled Trials ISRCTN52040363.This project was funded by the NIHR Health Technology Assessment programme and will be published in full inIn about 50% of people with bowel cancer, cancer spreads to the liver (colorectal liver metastases) within 5 years of detection and treatment. Liver resection (i.e. surgical removal of a portion of the liver) is the standard treatment in people below 70 years of age who are otherwise well, provided that the liver cancer is confined to a limited part of the liver. Such patients are considered ‘low-risk’ patients. Older patients and those with major medical problems or extensive cancers are considered ‘high-risk’ patients, as they are at a higher risk of developing complications following liver resection. Thermal ablation destroys the liver cancers using a needle that heats the cancer deposits until they are destroyed. There is significant uncertainty as to whether or not ablation can offer equivalent survival compared with surgery for ‘high-risk’ patients. We planned and conducted a randomised controlled trial comparing ablation with surgery to resolve this uncertainty. In this trial, some patients received ablation and others received surgery. The treatment was allocated at random with neither patients nor the study organisers choosing the treatment. The trial had an internal pilot (i.e. a smaller version of the full trial to resolve any ‘teething problems’ and ensure that a sufficient number of participants can be included in the full trial). Only nine patients were recruited in the 1-year internal pilot, compared with the anticipated recruitment of 45 patients. Therefore, the trial closed early as a result of poor recruitment, and the uncertainty about the best treatment for high-risk patients with colorectal liver metastases continues. The main reasons for the poor recruitment included fewer than anticipated eligible participants, clinicians’ unconscious bias towards surgery, and patients’ preference for one treatment or the other. In the future, comparisons involving two very different treatments may benefit from a feasibility study or a longer period of pilot study to resolve any difficulties.

Published
2020

41. HEALTH RELATED QUALITY OF LIFE AND SOCIAL SUPPORT: A RURAL MOBILIZING FOR ACTION THROUGH PLANNING AND PARTNERSHIPS FEASIBILITY STUDY.

Author

Story, Chandra R., Knutson, Douglas, Wei-Kang Kao, Stuck, Anna, Shreffler, Rachel, Pratt, Kari, Croft, Julie M., and Miller, Bridget M.

Subjects
*HEALTH status indicators, *SOCIAL support, *RURAL population, *SOCIAL networks, *PUBLIC health personnel, *HEALTH
Abstract

Background: Rural communities face geographical health inequities that can reduce quality of life. Hoiuever, rural communities are thought to have close social netiuorks and higher levels of support. The purpose of the current study luas to determine the feasibility of utilizing a social support measure luithin the Mobilizing for Action through Planning and Partnerships (MAPP) quality of life assessment process. Methods: Study participants (n=242, mean age: 46.5) completed a demographic questionnaire, Sense of Social Support Scale, and selected questions from the World Health Organization Quality of Life survey. Results: Findings indicate that perceived social support predicts health related quality of life (p=<. 001). In terms of social support, keeping in touch luith friends and solicitation of help from fiendsivere negatively associated luith quality of life (p=.001; p=. 018) respectively. The relationship betiueen income level and health related quality of life luas statistically significant (p=.018). Implications and Conclusions: Findings indicate that the measurement of social support and health related quality of life can be beneficial luithin a general rural community sample. Incorporation of social support measures luithin community based quality of life assessments can assist public health professionals luith the development of appropriate programs and services. [ABSTRACT FROM AUTHOR]

Published
2016

42. 'The unexpected journey': a qualitative interview study exploring patient and health professionals experiences of participating in the knee arthroplasty versus joint distraction study (KARDS).

Author

Arnold S, Pandit H, Croft J, Stocken DD, and Ellard DR

Subjects
Humans, Female, Male, Middle Aged, Knee Joint surgery, Aged, Osteoarthritis, Knee surgery, Health Personnel psychology, Attitude of Health Personnel, Qualitative Research, Arthroplasty, Replacement, Knee psychology, Arthroplasty, Replacement, Knee rehabilitation, Interviews as Topic
Abstract

Objective: The aim of the knee arthroplasty versus joint distraction (KARDS) randomised trial was to investigate whether knee joint distraction (KJD) is non-inferior to knee arthroplasty, also known as knee replacement (KR). Here we report the findings from qualitative interviews that were part of the planned KARDS process evaluation., Design and Methods: Semi-structured qualitative interviews with staff and participants in secondary care. Data were analysed using thematic content analysis., Findings: We were unable to complete the full-planned KARDS process evaluation as recruitment to the trial was closed early but key common themes emerged.Eleven members of staff were interviewed from two KARDS sites (eight initial interviews just after site opening and three follow-up interviews at 12 months). Eleven KARDS participants (six KR and five KJD) were interviewed. One overarching theme emerged: 'An unexpected journey'. This incorporated subthemes including 'an important research question', 'a roller coaster ride', 'lessons learnt', 'managing expectations' and 'a slow recovery'. These encapsulate experiences of both staff and participants., Conclusion: The information that we were able to collect highlights that providing adequate and comprehensive information about all aspects of treatment including estimated timelines of recovery are essential in clinical trials of novel interventions. Incorporating a comprehensive rehabilitation package following KJD was a key learning. Process evaluations in these complex trials are essential to determine issues as early as possible so appropriate changes can be made to ensure participants have a smooth journey through the trial experience., Trial Registration Number: ISRCTN14879004., Competing Interests: Competing interests: None declared., (© Author(s) (or their employer(s)) 2024. Re-use permitted under CC BY. Published by BMJ.)

Published
2024
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43. Robotic-assisted surgery compared with laparoscopic resection surgery for rectal cancer: the ROLARR RCT

Author

Jayne D, Pigazzi A, Marshall H, Croft J, Corrigan N, Copeland J, Quirke P, West N, Edlin R, Hulme C, and Brown J

Abstract

Background: Robotic rectal cancer surgery is gaining popularity, but there are limited data about its safety and efficacy., Objective: To undertake an evaluation of robotic compared with laparoscopic rectal cancer surgery to determine its safety, efficacy and cost-effectiveness., Design: This was a multicentre, randomised trial comparing robotic with laparoscopic rectal resection in patients with rectal adenocarcinoma., Setting: The study was conducted at 26 sites across 10 countries and involved 40 surgeons., Participants: The study involved 471 patients with rectal adenocarcinoma. Recruitment took place from 7 January 2011 to 30 September 2014 with final follow-up on 16 June 2015., Interventions: Robotic and laparoscopic rectal cancer resections were performed by high anterior resection, low anterior resection or abdominoperineal resection. There were 237 patients randomised to robotic and 234 to laparoscopic surgery. Follow-up was at 30 days, at 6 months and annually until 3 years after surgery., Main Outcome Measures: The primary outcome was conversion to laparotomy. Secondary end points included intra- and postoperative complications, pathological outcomes, quality of life (QoL) [measured using the Short Form questionnaire-36 items version 2 (SF-36v2) and the Multidimensional Fatigue Inventory-20 (MFI-20)], bladder and sexual dysfunction [measured using the International Prostatic Symptom Score (I-PSS), the International Index of Erectile Function (IIEF) and the Female Sexual Function Index (FSFI)], and oncological outcomes. An economic evaluation considered the costs of robotic and laparoscopic surgery, including primary and secondary care costs up to 6 months post operation., Results: Among 471 randomised patients [mean age 64.9 years, standard deviation (SD) 11.0 years; 320 (67.9%) men], 466 (98.9%) patients completed the study. Data were analysed on an intention-to-treat basis. The overall rate of conversion to laparotomy was 10.1% and occurred in 19 (8.1%) patients in the robotic-assisted group and in 28 (12.2%) patients in the conventional laparoscopic group {unadjusted risk difference 4.12% [95% confidence interval (CI) –1.35% to 9.59%], adjusted odds ratio 0.61 [95% CI 0.31 to –1.21]; p  = 0.16}. Of the nine prespecified secondary end points, including circumferential resection margin positivity, intraoperative complications, postoperative complications, plane of surgery, 30-day mortality and bladder and sexual dysfunction, none showed a statistically significant difference between the groups. No difference between the treatment groups was observed for longer-term outcomes, disease-free and overall survival (OS). Males were at a greater risk of local recurrence than females and had worse OS rates. The costs of robotic and laparoscopic surgery, excluding capital costs, were £11,853 (SD £2940) and £10,874 (SD £2676) respectively., Conclusions: There is insufficient evidence to conclude that robotic rectal surgery compared with laparoscopic rectal surgery reduces the risk of conversion to laparotomy. There were no statistically significant differences in resection margin positivity, complication rates or QoL at 6 months between the treatment groups. Robotic rectal cancer surgery was on average £980 more expensive than laparoscopic surgery, even when the acquisition and maintenance costs for the robot were excluded., Future Work: The lower rate of conversion to laparotomy in males undergoing robotic rectal cancer surgery deserves further investigation. The introduction of new robotic systems into the market may alter the cost-effectiveness of robotic rectal cancer surgery., Trial Registration: Current Controlled Trials ISRCTN80500123., Funding: This project was funded by the Efficacy and Mechanism Evaluation (EME) programme, a Medical Research Council and National Institute for Health Research (NIHR) partnership, with contributions from the Chief Scientist Office, Scottish Government Health and Social Care Directorate, the Health and Care Research Wales and the Health and Social Care Research and Development Division, Public Health Agency in Northern Ireland. The funders of the study had no role in the design and conduct of the study; collection, management, analysis and interpretation of the data; and preparation, review or approval of the manuscript or the decision to submit for publication. The project will be published in full in Efficacy and Mechanism Evaluation ; Vol. 6, No. 10. See the NIHR Journals Library website for further project information. Philip Quirke and Nicholas West were supported by Yorkshire Cancer Research Campaign and the MRC Bioinformatics initiative. David Jayne was supported by a NIHR Research Professorship., (Copyright © Queen’s Printer and Controller of HMSO 2019. This work was produced by Jayne et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.)

Published
2019
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