Search

We sought to compare VeraCept (VC175), a novel nitinol intrauterine contraceptive (IUC) with 175 square-mm of copper surface area, to a copper T380S IUC.We enrolled parous women into a randomized subject-blinded comparison of VC175 and a copper T380S in a 2:1 fashion at a single clinic. The primary outcomes were total adverse events and continuation at 12 months. We also examined pain on insertion, ease of placement, expulsion, tolerability and pregnancy. Subjective ratings were on a 5-point Likert scale (0, no pain to 5, worst pain). We followed subjects through 24-month follow-up.We enrolled 300 women with 199 randomized to VC175 and 101 to the T380S. Insertion was successful in 198 subjects for VC175 and 100 for the T380S. Mean age was 25 years (range 18, 41), and median parity was 2 (range 1, 8), with 39% having only had Cesarean deliveries. No subjects developed clinical infection or reported serious adverse events. In the VC175 and T380S groups, mean pain at insertion was 1.4 and 2.4, respectively (p.01). At the 12-month primary endpoint for VC175 and T380S, respectively, continuation was 84% and 68% (p.002) with expulsions in 5.0% and 12.0% (p.05) and removal for pain/bleeding in 3.5% and 17.0% (p.01). At the 24-month visit for VC175 and T380S, respectively, continuation was 77% and 62% (p.02 by log-rank). One ectopic pregnancy was identified at the 12-month follow-up in a VC175 user. No other pregnancies were diagnosed. With 297.3 and 132.4 woman-years, pregnancy rates were 0.3 and 0.0 per 100 woman-years for VC175 and T380S, respectively.VC175 resulted in less pain at insertion, fewer expulsions and higher total continuation than the T380S, with similar contraceptive efficacy.VC175 is a promising new intrauterine copper contraceptive on a nitinol frame that warrants further clinical trials.

The authors present their experience with the detection of the sentinel node, which is the first node to receive drainage from a malignant tumor, in patients with cervical cancer. Fifty women who were scheduled to undergo radical abdominal hysterectomy and systematic pelvic lymphadenectomy for treatment of stage IA2 to IIA primary carcinoma of cervix from January 2003 to January 2005 served as study subjects. Sentinel lymph node (SNL) mapping was done with an intracervical injection of 4 mL methylene blue. Pelvic lymph nodes appeared blue 15 minutes after dye injection and remained colored for 70 minutes. A 25-gauge standard needle was used to slowly, under constant pressure, inject the dye into the cervix to a depth of 5 to 10 mm at 3, 6, 9, and 12 o'clock positions, taking care to avoid injecting into the tumor itself. The abdomen was then opened, and the right retroperitoneal space on the right pelvis was opened. Using blunt dissection, the avascular paravesical and pararectal spaces were developed. The blue lymphatics could then be followed to the first node with obvious or faint dye uptake. This sentinel node was dissected and removed. The procedure was repeated on the left side before proceeding with lymphadenectomy. After the SNLs were removed on both sides, bilateral pelvic lymphadenectomy followed by radical hysterectomy was performed in all patients. The technique was considered to have failed when no sentinel node was identified or when there was inadequate injection of the dye. If the SNL was negative on histology, but other nodes in the drainage area were positive, the outcome was considered to be a false-negative. Sentinel nodes were considered positive when they contained macrometastases, micrometastases, or isolated tumor cells. Sentinel nodes were processed in the routine fashion with hematoxylin & eosin staining, but negative sentinel nodes underwent additional processing using serial step sections and wide-spectrum cytokeratin immunohistochemical analysis. The mean age of participants was 45.9 years. The most common preoperative diagnosis was clinical stage IB1 cervical cancer. Two women had microinvasive cancer stage IA2. Seventeen patients underwent a cone biopsy before surgery. Residual carcinoma in situ was diagnosed in 18% of these patients, one third of whom had lesions larger than 2 cm. A total of 1093 lymph nodes were retrieved (mean, 21.9 per patient). Eighty-six sentinel nodes were identified in 45 patients (detection rate, 90%). Forty SNLs were on the right side in 34 patients, and 46 SNLs were on the left side in 38 patients. Twenty-five women (50%) had two SNLs identified and 18 (26%) had one SNL identified. In five women, there were three SNLs, and two patients had four sentinel nodes. No sentinel nodes were identified in five patients (failure rate, 10%). Inadequate injection technique with intraperitoneal spillage accounted for two of the failures. A third was attributed to injection of the methylene blue into the tumor in a woman with bulky cervical cancer. After this, patients with bulky tumors were excluded from the study. The external iliac and obturator areas were the most common sites of SNL (55% and 38%, respectively). SNLs were similarly distributed on both sides of the pelvis. In this series, sentinel nodes detected in the common iliac area (n = 5) typically were the only positive nodes found on the same side. There was one parametrial SNL, but no dye could be seen beyond it. Twenty-five positive nodes were identified in 10 patients (20%), including seven with unilateral involvement and three with bilateral spread. Thirteen of the 25 positive nodes were identified as sentinel nodes and were found in nine of the 10 patients. In five patients, the SNL was the only positive node detected. The one woman with a false-negative SNL had stage IB 1 squamous cervical cancer and one positive right parametrial lymph node and 35 negative pelvic lymph nodes. Bilateral SNLs identified in this patient were negative by serial step and wide-spectrum cytokeratin immunohistochemical analysis.