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Comparing two surgery methods for bowel involvement in ovarian cancer

Compares two bowel surgeries in adults with ovarian cancer spread to the rectosigmoid.

Key facts

Who runs it
Cukurova University
Where
Adana, TürkiyeSee the site
Trial code
Registry title
Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery
Status
Recruiting
People taking part
120 people, planned
Started
1 Mar 2021
Expected to end
Dec 2026
Type of study
Interventional, 2 groupsOne group gets an existing treatment, for comparison.
Treatments tested
  • Rectosigmoid resection
Record updated
29 August 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for women aged 18 or older with epithelial ovarian cancer that has spread to the outer or muscle layer of the rectosigmoid bowel during surgery. It compares removing that bowel part with shaving the tumor off.

Age
18 Years or older
Sex
Women only
Disease stage
Epithelial ovarian cancer. The surgeon confirms during the operation that the tumor has reached the outer layer (serosa) or the outer and muscle layers (seromuscular) of the rectosigmoid bowel. The colonoscopy must show no involvement of the inner lining (mucosa).

Main reasons for not taking part

  • Ovarian cancer that is not epithelial
  • Tumor reaching the inner lining (mucosa) of the rectosigmoid bowel
  • Need for removal of the whole or almost the whole colon because of large bowel spread
  • ECOG score above 2
  • ASA score above 2

The registry criteria, word for word

Show all 10 criteriaShow less

Who can take part

  • Epithelial ovarian cancer
  • Negative colonoscopy ( no mucosal involvement)
  • Intraoperative confirmed serosal or seromuscular rectosigmoid infiltration
  • ECOG <3
  • ASA <3

Who cannot take part

  • Nonepithelial ovarian cancers
  • Rectosigmoid mucosal infiltration
  • Total or subtotal colectomy necessitating large bowel infiltrations
  • ECOG >2
  • ASA >2

Where in Türkiye

  • Cukurova UniversityAdana, TürkiyeContact: Ghanim Khatib, MDNot yet recruiting

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 2 groups in the trial

  • Rectosigmoid resectionExisting treatment, for comparison
  • Rectosigmoid seromuscular tumor shavingExisting treatment, for comparison

    Treatment: Rectosigmoid resection

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Comparison of Rectosigmoid Resection and Seromuscular Tumor Shaving Methods in Ovarian Cancer Surgery (BROSEOC)
Plain-language title
Comparing two surgery methods for bowel involvement in ovarian cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
29 August 2024