Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

Study Overview
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Brief Summary
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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.

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

Conditions
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Epithelial Ovarian Cancer, Rectosigmoid Cancer Metastatic

Intervention / Treatment
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* Procedure: Rectosigmoid resection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Epithelial ovarian cancer Negative colonoscopy ( no mucosal involvement) Intraoperative confirmed serosal or seromuscular rectosigmoid infiltration ECOG <3 ASA <3 Exclusion Criteria: Nonepithelial ovarian cancers Rectosigmoid mucosal infiltration Total or subtotal colectomy necessitating large bowel infiltrations ECOG >2 ASA >2

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rectosigmoid resection<br> | Procedure: Rectosigmoid resection<br>* 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.<br>* Other names: Rectosigmoid seromuscular tumor shaving;|
| Active Comparator: Rectosigmoid seromuscular tumor shaving<br> | Procedure: Rectosigmoid resection<br>* 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.<br>* Other names: Rectosigmoid seromuscular tumor shaving;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local pelvic recurrence | Only the pelvic recurrences determined after the last chemotherapy cycle. | 0-60 months. | 
| Recurrence-free survival | The time from the last chemotherapy cycle to determination of any recurrence in any location. | 0-60 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cancer specific survival | Time from diagnosis to the death date due to ovarian cancer. | 0-100 months | 
| Surgery related morbidities | Any surgery related morbidity during 90 days. | 90 days. | 
| Health related Quality of life | HRQoL will be assessed with the European Organization for Research and Treatment of Cancer (EORTC) core questionnaire (EORTC QLQ-C30 version 3.0).The QLQ-C30 is a 30-item questionnaire that includes five multiitem functional scales (physical, role, cognitive, emotional, and social), three multi-item symptom scales (fatigue, nausea and vomiting, and pain), five single-item symptom scales (dyspnoea, insomnia, appetite loss, constipation, and diarrhoea), a question on financial impact; and a two-item global quality of life scale.The questionnaire generally has a four-point response scale (1 = not at all, 4 = very much).The questionnaire is planned to be performed within 1-2 weeks prior to the surgery (baseline), after 3-4 weeks of surgery before starting of adjuvant chemotherapy, at the end of adjuvant chemotherapy, and every three months in follow-up, until two years of follow-up. | 0-24 months. | 
| Overall survival | Time from diagnosis to the death date due to any cause. | 0-100 months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epithelial ovarian cancer, Rectosigmoid resection, Seromuscular tumor shaving, recurrence