Clinical Trial

Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated August 29, 2024 (before its estimated January 2025 completion). Its status may not reflect the trial's current state.
Summary
Ovarian cancer is the most common cause of death in gynecological cancer. Approximately 75% of epithelial ovarian cancers are detected at an advanced stage. Metastasis and spread are mostly through transperitoneal planting and neighborhood by shedding from the ovarian surface. Metastasis mostly occurs in the peritoneum, omentum, and intestines. The rectosigmoid colon is the main part of the intestine affected by metastasis due to its neighborhood. Treatment in ovarian cancer consists of a combination of cytoreduction surgery and platinum-based chemotherapy. Surgery is the basis of the treatment, and the main goal is to achieve no residual visible tumor (complete cytoreduction: R0). The residual tumor is one of the main factors affecting survival and reflects the possibilities of the surgical center and the team. Multiple surgical procedures (total hysterectomy, bilateral salpingo-oophorectomy, total omentectomy, peritonectomy, retroperitoneal lymphadenectomies such as pelvic and paraaortic, bowel resections, splenectomy, distal pancreatectomy, various resections related to the bladder, liver, stomach, and diaphragm) may be required to achieve complete or optimal cytoreduction. In the involvement of the rectosigmoid colon, primarily the serosa, then the muscular layer and finally the mucosa are infiltrated due to the nature of the spread, and therefore most of the involvement is observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed. There are advantages and disadvantages of each method in terms of morbidity. Although there are retrospective studies evaluating recurrence and survival between both methods, as far as investigators know, no randomized prospective studies have been conducted comparing these two methods. The investigators designed this study to compare these two methods successfully applied in our clinic in a prospective randomized study.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2020-12-07; most recent amendment 2024-08-28.
Status change: Not Yet Recruiting → Recruiting 2021-07-26
Trial Details
NCT Number NCT04665635
Lead Sponsor Cukurova University
Conditions Epithelial Ovarian Cancer, Rectosigmoid Cancer Metastatic
Enrollment 120 participants
Start Date 2021-03-01
Primary Completion 2025-01 (estimated)
Study Completion 2026-12 (estimated)
Updated on ClinicalTrials.gov 2024-08-29