Laparoscopic sacral colpopexy and a new approach to mesh fixation: a randomized clinical trial

Purpose

Laparoscopic sacral colpopexy (LSC) plus supracervical hysterectomy (LSH) for pelvic organ prolapse (POP) is a high-complexity surgical procedure. The aim of the present study was to evaluate a new approach to vaginal-mesh fixation during LSC with continuous locked suture.

Methods

This is a prospective randomized double-blinded clinical trial enrolling 90 patients with severe POP from January 2016 to April 2017. Patients underwent LSH plus a “two-meshes” LSC and were randomized, regarding mesh fixation, in Group 1 (extracorporeal interrupted 3-0 delayed absorbable sutures) and Group 2 (running locked 3-0 delayed absorbable suture). Our primary endpoints were the operative times and the secondary endpoints the incidence of intra- or post-operative complications.

Results

A total of 42 patients for group completed the study. Baseline characteristics were similar between the groups. Overall mesh fixation time (24 vs. 39 min; p?<?0.01), and operative time (121 vs. 138 min; p?<?0.05) resulted significantly lower in Group 2. No differences were found in terms of anatomic failure, vaginal mesh erosion or intra- or post-operative complications.

Conclusions

Laparoscopic continuous locked 3-0 absorbable suture for anterior and posterior mesh fixation during LSC guaranteed a faster and effective alternative to multiple interrupted sutures. The significant operative time reduction linked to this technique should be considered even more helpful when performing a highly complex surgery such as LSC.

     

Feasibility and outcome of interval debulking surgery (IDS) after carboplatin-paclitaxel-bevacizumab (CPB): A subgroup analysis of the MITO-16A-MaNGO OV2A phase 4 trial

Background

Few data are available on the outcome of surgery after a bevacizumab-containing regimen. The MITO 16A- MaNGO OV2A phase 4 trial evaluates the outcomes of first-line CPB in a clinical-practice-like setting. Here we present the results of the subgroup of patients undergoing IDS after neoadjuvant treatment or suboptimal primary surgery.

Efficacy and safety results from OCTAVIA,a single-arm phase II study evaluating front-line bevacizumab,carboplatin and weekly paclitaxel for ovarian cancer

PurposeThe single-arm OCTAVIA study evaluated front-line bevacizumab plus weekly paclitaxel and q3w carboplatin.Patients and methodsPatients with newly diagnosed ovarian cancer (International Federation of Gynecology and Obstetrics [FIGO] stage IIb–IV or grade 3/clear-cell stage I/IIA) received bevacizumab (7.5 mg/kg, day 1), weekly paclitaxel (80 mg/m² days 1, 8, 15) and carboplatin (area under the curve 6 [AUC6], day 1) intravenously q3w for 6–8 cycles, followed by single-agent bevacizumab (total 1 year). The primary objective was to demonstrate median progression-free survival (PFS) > 18 months according to the lower 90% confidence limit. Secondary end-points included objective response rate, overall survival, safety and tolerability.ResultsMost (74%) of the 189 treated patients had stage IIIC/IV disease, similar to the ICON7 population. Patients received a median of six chemotherapy and 17 bevacizumab cycles. At the predefined cutoff 24 months after last patient enrolment, 99 patients (52%) had progressed and 19 (10%) had died, all from ovarian cancer. Median PFS was 23.7 months (95% confidence interval [CI], 19.8–26.4 months), 1-year PFS rate was 85.6%, Response Evaluation Criteria in Solid Tumors (RECIST) response rate was 84.6% and median response duration was 14.7 months. Most patients (?90%) completed at least six chemotherapy cycles. Grade ?3 peripheral sensory neuropathy occurred in 5% and febrile neutropenia in 0.5%. Grade ?3 adverse events typical of bevacizumab were no more common than in phase III bevacizumab ovarian cancer trials. There was one case of gastrointestinal perforation (0.5%) and no treatment-related deaths.ConclusionOCTAVIA met its primary objective, demonstrating median PFS of approximately 2 years. This bevacizumab-containing regimen is active and tolerable.     

HIPEC in recurrent ovarian cancer patients: morbidity-related treatment and long-term analysis of clinical outcome

Objective

To evaluate morbidity and mortality rates associated with the use of hyperthermic intraoperative intraperitoneal chemotherapy (HIPEC) after optimal cytoreduction (CRS) in a large single-institutional series of platinum-sensitive recurrent ovarian cancer patients. Moreover, disease free (DFS) and overall survival (OS) of previously studied patients have been assessed after a longer follow-up period.

Method

From May 2005 to October 2010, recurrent ovarian cancer patients with a platinum-free interval of at least 6 months have been prospectively enrolled in a protocol of CRS plus HIPEC with oxaplatinum (460 mg/m²) heated to 41.5 °C for 30 min, followed by 6 cycles of systemic chemotherapy with taxotere 75 mg/m² and oxaliplatin 100 mg/m².

Results

Forty-one patients experienced 43 procedures (CRS + HIPEC). An optimal cytoreduction was achieved in all cases (CC-0 95.3%; CC-1 4.7%). A complication rate of 34.8% was registered, with no case of intraoperative death or within 30 days after surgery. Survival curves have been calculated in a group of 25 patients with a minimum follow-up of 18 months, obtaining a median DFS and OS of 24 (range 6-60) and 38 months (range 18-60), respectively.

Conclusion

In recurrent platinum-sensitive ovarian cancer patients, the use of CRS plus HIPEC represents a safe treatment, able to significantly influence the survival rates compared to chemotherapy alone or surgery plus standard chemotherapy.     

Laparoscopic Myomectomy at 25 Weeks of Pregnancy: Case Report

We performed laparoscopic myomectomy for treatment of a large, twisted, subserous myoma at 25 weeks of pregnancy in a woman with acute abdominal pain that did not respond to analgesic therapy. There are few reports in literature about laparoscopic management of uterine leiomyoma during the first half of pregnancy that demonstrate its feasibility in selected cases. Laparoscopic myomectomy can be considered a minimally invasive alternative to the traditional laparotomy when myomectomy is necessary during the second half of pregnancy, resulting in less postoperative pain and shorter recovery time.