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2. Study protocol for a multicenter non-inferiority randomized controlled trial to assess functional outcomes and cost-effectiveness of a primarily non-operative treatment strategy with cast immobilization versus immediate operative treatment followed by cast immobilization for patients with complete ulnar collateral ligament ruptures, including Stener lesions: MUSCAT study

Author

de Haas, Louise, van Hoorn, Bastiaan, van de Lücht, Veronique, Schep, N., Dijkgraaf, M., van Heijl, M., Debeij, J., Derksen, B., Greeven, A., Engelen, M., de Jong, J., van Laarhoven, C., Lenderink, A., Leijdesdorff, A., Leliveld, M., Leszczynksi, M., Liebrand, R., Meesters, B., Ottenhof, A., and Pesch, C.

Subjects
ULNAR collateral ligament, MEDICAL research ethics, MEDICAL ethics committees, LIGAMENT injuries, RANDOMIZED controlled trials, THUMB
Abstract

Background: Guidelines recommend operative treatment followed by cast immobilization for acute complete ulnar collateral ligament (UCL) ruptures, including Stener lesions. This recommendation is based on expert opinion, anatomic theories, and low-quality observational case series. High-quality studies comparing non-operative treatment to operative treatment are lacking. We hypothesize that primarily non-operative treatment with cast immobilization (cast immobilization) is non-inferior regarding functional outcome and carries concomitant lower costs compared with immediate operative treatment followed by cast immobilization (operative treatment) for complete UCL ruptures, including Stener lesions. Methods: This is a multicenter randomized controlled non-inferiority trial (RCT) including patients of 18 years and above, requiring treatment for an acute complete UCL rupture, including Stener lesions. Patients are randomized to cast immobilization or operative treatment followed by cast immobilization. Immobilization consists of 4 weeks of a non-removable cast around the metacarpophalangeal (MCP) and carpometacarpal (CMC) joint of the thumb in a neutral position, followed by a removable cast for 4 weeks for both groups. Patients in the cast immobilization group are re-evaluated 2 to 3 weeks after the start of cast immobilization to examine thumb stability and determine if secondary surgery is required. In case of persistent laxity, secondary surgery is required. The primary outcome is hand function expressed as the Michigan Hand outcome Questionnaire (MHQ) at 6 months (from injury to 6 months after). Discussion: If cast immobilization is non-inferior to operative treatment, the proposed treatment strategy will reduce patient burden by preventing surgery. It is expected that about one in ten patients who started with cast immobilization will need secondary surgery during re-evaluation. As a result, completion of the treatment will take longer for these patients compared to patients who received immediate operative treatment. Trial registration: Central Committee on Research Involving Human Subjects (CCMO), NL78886.100.21; registered on 4 October 2021. Medical Research Ethics Committees United (MEC-U), R21.006; registered on 09 December 2021. Clinical Trial register, identifier: NCT05291260; retrospectively registered on 22 March 2022. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Inguinal Hernia: Post OP Chronic Pain

Author

Sevonius, D., Montgomery, A., Smedberg, S., Sandblom, G., Zwaans, W., Perquin, C., Roumen, R., Scheltinga, M., Verhagen, T., Loos, M. J. A., Scheltinga, M. R. M., Roumen, R. M. H., Bökkerink, W., Van Laarhoven, C. J. H. M., Koning, G. G., Yang, Z. F., Shen, W. Z., Lu, C., Zheng, W. H., Xiao, W. F., Li, X. R., Narita, M., Matsusue, R., Hata, H., Yamaguchi, T., Otani, T., Ikai, I., Karampinis, I., Weiss, J., Pilz, L., Post, S., Herrle, F., Murphy, J., Yang, F., Meng, L. Q., Meng, X. Z., Chong, Y. Z., Zhao, H. Y., Liu, J. G., van Assen, T., Brouns, J. A. G. M., Scheltinga, M. R., and Roumen, R. M.

Published
2015
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15. Comparison of the ROME-III Criteria and a New Multivariable Prediction Model for the Selection of Patients with Symptomatic Cholecystolithiasis for Cholecystectomy

Author

Latenstein, C., primary, Hannink, G., additional, van der Bilt, J., additional, Donkervoort, S., additional, Eijsbouts, Q., additional, Heisterkamp, J., additional, Nieuwenhuijs, V., additional, Schreinemakers, J., additional, Wiering, B., additional, Boermeester, M., additional, Drenth, J., additional, van Laarhoven, C., additional, Dijkgraaf, M., additional, and de Reuver, P., additional

Published
2022
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26. Trends in Treatment and Survival of Gallbladder Cancer in the Netherlands; Identifying Gaps and Opportunities from a Nation-Wide Cohort

Author

Lohman, ED, de Bitter, T, Verhoeven, R, van der Geest, L, Hagendoorn, J, Mohammad, NH, Daams, F, Klumpen, HJ, van Gulik, T, Erdmann, J, Boer, M, Hoogwater, F, Groot Koerkamp, B, Braat, A, Verheij, J, Nagtegaal, I, van Laarhoven, C, van den Boezem, P, Post, R, de Reuver, P, Lohman, ED, de Bitter, T, Verhoeven, R, van der Geest, L, Hagendoorn, J, Mohammad, NH, Daams, F, Klumpen, HJ, van Gulik, T, Erdmann, J, Boer, M, Hoogwater, F, Groot Koerkamp, B, Braat, A, Verheij, J, Nagtegaal, I, van Laarhoven, C, van den Boezem, P, Post, R, and de Reuver, P

Published
2020

28. Diagnostic accuracy of contrast-enhanced diffusion-weighted MRI for liver metastases of pancreatic cancer: Towards adequate staging and follow-up of pancreatic cancer - DIA-PANC study: Study protocol for an international, multicenter, diagnostic trial

Author

Pathologie Pathologen staf, Cancer, Zorgeenheid Plastische Chirurgie Medisch, Litjens, G., Rivière, D. M., Van Geenen, E. J.M., Radema, S. A., Brosens, L. A.A., Prokop, M., Van Laarhoven, C. J.H.M., Hermans, J. J., Pathologie Pathologen staf, Cancer, Zorgeenheid Plastische Chirurgie Medisch, Litjens, G., Rivière, D. M., Van Geenen, E. J.M., Radema, S. A., Brosens, L. A.A., Prokop, M., Van Laarhoven, C. J.H.M., and Hermans, J. J.

Published
2020

29. Gadolinium Enhancement of the Aneurysm Wall in Extracranial Carotid Artery Aneurysms

Author

Circulatory Health, Zorgeenheid Vaatchirurgie Medisch, Other research (not in main researchprogram), Researchgr. Cardiovasculaire Radiologie, MS Radiologie, Researchgr. Neuroradiologie, Brain, ZL Cerebrovasculaire Ziekten Medisch, Regenerative Medicine and Stem Cells, van Laarhoven, C. J.H.C.M., Rots, M. L., Pourier, V. E.C., Jorritsma, N. K.N., Leiner, T., Hendrikse, J., Vergouwen, M. D.I., de Borst, G. J., Circulatory Health, Zorgeenheid Vaatchirurgie Medisch, Other research (not in main researchprogram), Researchgr. Cardiovasculaire Radiologie, MS Radiologie, Researchgr. Neuroradiologie, Brain, ZL Cerebrovasculaire Ziekten Medisch, Regenerative Medicine and Stem Cells, van Laarhoven, C. J.H.C.M., Rots, M. L., Pourier, V. E.C., Jorritsma, N. K.N., Leiner, T., Hendrikse, J., Vergouwen, M. D.I., and de Borst, G. J.

Published
2020

41. A multicentre randomized non-inferiority trial comparing usual care to restrictive strategy for use of cholecystectomy in patients with gallstones and abdominal pain (SECURE trial)

Author

Wennmacker, S., primary, Van Dijk, A., additional, De Reuver, P., additional, Latenstein, C., additional, Buyne, O., additional, Donkervoort, S., additional, Eijsbouts, Q., additional, Heisterkamp, J., additional, In 't Hof, K., additional, Jansen, J., additional, Nieuwenhuijs, V., additional, Schaap, H., additional, Van Steenvoorde, P., additional, Stockmann, H., additional, Boerma, D., additional, Westert, G., additional, Drenth, J., additional, Dijkgraaf, M., additional, Boermeester, M., additional, and Van Laarhoven, C., additional

Published
2020
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43. Does jaundice preclude resection in gallbladder cancer?

Author

De Savornin Lohman, E., primary, De Bitter, T., additional, Verhoeven, R., additional, Van laarhoven, C., additional, Erdmann, J., additional, Van der Post, R., additional, Koerkamp, B Groot, additional, Braat, A., additional, Van den Boezem, P., additional, Van Gulik, T., additional, and De Reuver, P., additional

Published
2020
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46. Trends in incidence, treatment and survival of gallbladder cancer; a nation-wide cohort study

Author

De Savornin Lohman, E., primary, De Bitter, T., additional, Verhoeven, R., additional, Van der Geest, L., additional, Hagendoorn, J., additional, Mohammad, N Haj, additional, Daams, F., additional, Klumpen, H., additional, Van Gulik, T., additional, Erdmann, J., additional, De Boer, M., additional, Hoogwater, F., additional, Koerkamp, B Groot, additional, Braat, A., additional, Verheij, J., additional, Van laarhoven, C., additional, Nagtegaal, I., additional, Van den Boezem, P., additional, Van der Post, R., additional, and De Reuver, P., additional

Published
2020
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50. Costs and quality of life in a randomized trial comparing minimally invasive and open distal pancreatectomy (LEOPARD trial)

Author

van Hilst, J., Strating, E. A., de Rooij, T., Daams, F., Festen, S., Groot Koerkamp, B., Klaase, J. M., Luyer, M., Dijkgraaf, M. G., Besselink, M. G., van Santvoort, H. C., de Boer, M. T., Boerma, D., van den Boezem, P. B., van Dam, R. M., Dejong, C. H., van Duyn, E. B., van Eijck, C. H., Gerhards, M. F., de Hingh, I. H., Kazemier, G., de Kleine, R. H., van Laarhoven, C. J., Patijn, G. A., Steenvoorde, P., Suker, M., Hilal, M. Abu, RS: NUTRIM - R2 - Liver and digestive health, MUMC+: MA Heelkunde (9), Surgery, Groningen Institute for Organ Transplantation (GIOT), Value, Affordability and Sustainability (VALUE), AGEM - Re-generation and cancer of the digestive system, CCA - Cancer Treatment and quality of life, Epidemiology and Data Science, APH - Methodology, AGEM - Digestive immunity, and CCA - Cancer Treatment and Quality of Life

Subjects
Male, Cost effectiveness, SURGERY, Cost-Benefit Analysis, INTERNATIONAL STUDY-GROUP, OPEN ILEOCOLIC RESECTION, law.invention, BODY-IMAGE, Tumours of the digestive tract Radboud Institute for Health Sciences [Radboudumc 14], Postoperative Complications, 0302 clinical medicine, Robotic Surgical Procedures, Quality of life, Randomized controlled trial, law, Hospital Costs/statistics & numerical data, Outcome Assessment, Health Care, 80 and over, Single-Blind Method, Hospital Costs, Laparoscopy, Netherlands, Aged, 80 and over, medicine.diagnostic_test, Middle Aged, Multicenter Study, Patient Satisfaction, 030220 oncology & carcinogenesis, Randomized Controlled Trial, Original Article, 030211 gastroenterology & hepatology, Female, Quality-Adjusted Life Years, Adult, medicine.medical_specialty, Pancreatectomy/economics, COSMESIS, 03 medical and health sciences, Outcome Assessment (Health Care), All institutes and research themes of the Radboud University Medical Center, Pancreatectomy, Patient satisfaction, medicine, Journal Article, Humans, Comparative Study, Aged, Laparoscopy/economics, business.industry, Cosmesis, Original Articles, Recovery of Function, Confidence interval, Surgery, Quality-adjusted life year, Postoperative Complications/economics, DEFINITION, Quality of Life, Robotic Surgical Procedures/economics, business, Follow-Up Studies
Abstract

Background Minimally invasive distal pancreatectomy decreases time to functional recovery compared with open distal pancreatectomy, but the cost-effectiveness and impact on disease-specific quality of life have yet to be established. Methods The LEOPARD trial randomized patients to minimally invasive (robot-assisted or laparoscopic) or open distal pancreatectomy in 14 Dutch centres between April 2015 and March 2017. Use of hospital healthcare resources, complications and disease-specific quality of life were recorded up to 1 year after surgery. Unit costs of hospital healthcare resources were determined, and cost-effectiveness and cost–utility analyses were performed. Primary outcomes were the costs per day earlier functional recovery and per quality-adjusted life-year. Results All 104 patients who had a distal pancreatectomy (48 minimally invasive and 56 open) in the trial were included in this study. Patients who underwent a robot-assisted procedure were excluded from the cost analysis. Total medical costs were comparable after laparoscopic and open distal pancreatectomy (mean difference €–427 (95 per cent bias-corrected and accelerated confidence interval €–4700 to 3613; P = 0·839). Laparoscopic distal pancreatectomy was shown to have a probability of at least 0·566 of being more cost-effective than the open approach at a willingness-to-pay threshold of €0 per day of earlier recovery, and a probability of 0·676 per additional quality-adjusted life-year at a willingness-to-pay threshold of €80 000. There were no significant differences in cosmetic satisfaction scores (median 9 (i.q.r. 5·75–10) versus 7 (4–8·75); P = 0·056) and disease-specific quality of life after minimally invasive (laparoscopic and robot-assisted procedures) versus open distal pancreatectomy. Conclusion Laparoscopic distal pancreatectomy was at least as cost-effective as open distal pancreatectomy in terms of time to functional recovery and quality-adjusted life-years. Cosmesis and quality of life were similar in the two groups 1 year after surgery.

Published
2019
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