RecruitingNot ApplicableNCT04665635

Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

Comparison of Rectosigmoid Resection and Seromuscular Tumor Shaving Methods in Ovarian Cancer Surgery (BROSEOC)

Sponsor

Cukurova University

Enrollment

120 participants

Start Date

Mar 1, 2021

Study Type

INTERVENTIONAL

Conditions

Epithelial Ovarian Cancer Rectosigmoid Cancer Metastatic

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.

Eligibility

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two surgical approaches for women with ovarian cancer that has grown into the wall of the rectum or sigmoid colon. One approach removes that section of bowel entirely; the other carefully shaves the tumor off the bowel surface without removing the bowel. Researchers want to find out which method is safer and equally effective. **You may be eligible if you:** - Have been diagnosed with epithelial ovarian cancer - Have cancer that has grown into the outer layer of the rectum or sigmoid colon (confirmed during surgery) - Have had a colonoscopy confirming no cancer has grown through the bowel lining - Are in reasonably good general health (ECOG less than 3, ASA less than 3) **You may NOT be eligible if you:** - Have a non-epithelial type of ovarian cancer - Have cancer that has grown through all layers of the bowel (mucosal infiltration) - Require removal of a large section of the colon - Are in poor general health Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURERectosigmoid resection

Most of the colorectal involvements are observed in the seromuscular layer. In seromuscular infiltration, resection of the rectosigmoid colon or shaving of tumoral implants without resection can be performed.