Rectosigmoid Resection vs Seromuscular Tumor Shaving in Ovarian Cancer Surgery

February 7, 2023 updated by: Ghanim Khatib, Cukurova University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Adana, Turkey, 01330
        • Recruiting
        • Cukurova University
        • Contact:
      • Adana, Turkey, 01330
        • Not yet recruiting
        • Cukurova University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ghanim Khatib, MD,Ass.Prof

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Rectosigmoid resection
Procedure: Rectosigmoid 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.
Other Names:
  • Rectosigmoid seromuscular tumor shaving
ACTIVE_COMPARATOR: Rectosigmoid seromuscular tumor shaving
Procedure: Rectosigmoid 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.
Other Names:
  • Rectosigmoid seromuscular tumor shaving

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local pelvic recurrence
Time Frame: 0-60 months.
Only the pelvic recurrences determined after the last chemotherapy cycle.
0-60 months.
Recurrence-free survival
Time Frame: 0-60 months.
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 Frame: 0-100 months
Time from diagnosis to the death date due to ovarian cancer.
0-100 months
Surgery related morbidities
Time Frame: 90 days.
Any surgery related morbidity during 90 days.
90 days.
Health related Quality of life
Time Frame: 0-24 months.
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 Frame: 0-100 months.
Time from diagnosis to the death date due to any cause.
0-100 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cukurova University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2021

Primary Completion (ANTICIPATED)

January 1, 2025

Study Completion (ANTICIPATED)

December 1, 2026

Study Registration Dates

First Submitted

November 30, 2020

First Submitted That Met QC Criteria

December 7, 2020

First Posted (ACTUAL)

December 11, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 105/17- Ov01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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