Rectosigmoid Lesion Excision vs. Resection: A Non-Inferiority Randomized Comparison in Advanced Ovarian Cancer (RSEnTrail)

May 29, 2026 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University

A Prospective Randomized Controlled Non-Inferiority Study Comparing the Efficacy of Lesion Excision Versus Rectosigmoid Resection in Pelvic Cytoreductive Surgery for Advanced Ovarian Cancer

Colorectum is the most common site of metastasis in ovarian cancer. Regarding intestinal surgery, there is controversy over whether to choose bowel resection or tumor removal, and currently, there are no prospective randomized controlled studies comparing the oncological safety of these two surgical approaches. This study is a prospective randomized trial aimed at comparing the efficacy of rectosigmoid resection versus rectosigmoid-preserving lesion excision in advanced ovarian cancer surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Gastrointestinal surgeries, such as intestinal resection and anastomosis, ileostomy and/or colostomy, have become an important step in more than 50% of advanced ovarian cancer tumor cell reduction surgeries. Among them, the sigmoid colon rectum is the main intestinal site affected by ovarian cancer metastasis. To achieve R0 tumor reduction surgery, partial sigmoid colon rectum resection is often performed simultaneously. However, approximately 2.3-6.8% of patients undergoing this surgery have intestinal anastomotic leakage, 17-18% of patients require prophylactic or permanent colostomy, and 40% of patients will experience changes in bowel habits and other rectal anterior low resection syndrome after surgery, which reduces the quality of life of the patients.

Numerous studies have found that the rectosigmoid colon involvement in ovarian cancer mainly occurs in the serosa, followed by the muscular layer, and finally the mucosa. Moreover, in 80% of cases, the involvement is limited to the seromuscular layer. Therefore, some studies have suggested that for seromuscular layer infiltration, resection of the rectosigmoid colon during cytoreductive surgery may not be necessary, and partial resection of the intestinal wall or tumor enucleation can be considered. Although tumor enucleation can preserve the rectosigmoid colon when it is involved, some studies have raised concerns about its oncological safety. These studies argue that not resecting the rectosigmoid colon may leave microscopic tumor residues, leading to a decrease in survival rates. In contrast, recent retrospective clinical studies have supported that, compared with intestinal resection, tumor enucleation of the rectosigmoid colon does not affect the prognosis of advanced ovarian cancer. Regarding intestinal metastasis of ovarian cancer, the current National Comprehensive Cancer Network(NCCN) guidelines for ovarian cancer state that preoperative neoadjuvant chemotherapy does not improve survival and therefore do not recommend it. Instead, the guidelines suggest direct surgical treatment. As for the surgical approach, the guidelines only require achieving R0 resection of the intestinal tumor, without specifying whether it is intestinal segment resection or tumor enucleation. Therefore, both rectosigmoid colon resection and tumor enucleation while preserving the rectosigmoid colon are common surgical methods in clinical practice. The investigator analyzed 130 cases of advanced ovarian cancer treated surgically in the investigator's hospital from 2015 to 2021, comparing the rectosigmoid colon resection group with the tumor enucleation group while preserving the rectosigmoid colon. The investigator found no difference in progression-free survival between the two groups, a conclusion consistent with published studies.

As there are currently no prospective randomized controlled studies comparing the oncological safety of these two surgical approaches, this study is a prospective randomized study comparing the efficacy of rectosigmoid resection and rectosigmoid-sparing tumor debulking in advanced ovarian cancer surgery. It was designed and led by the Second Affiliated Hospital of Zhejiang University School of Medicine, with the participation of multiple domestic hospitals. The study strictly adheres to Good Clinical Practice(GCP) requirements, is strictly managed, and records data truthfully to provide genuine and scientific research data. This study will provide satisfactory cytoreductive surgery and standardized treatment for enrolled patients, ensuring the patients's benefits. The study will provide reliable clinical evidence for the management of the intestinal tract in cytoreductive surgery for advanced ovarian cancer and introduce new surgical methods to improve the prognosis and quality of life of ovarian cancer patients.

Study Type

Interventional

Enrollment (Estimated)

300

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 Contact Backup

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Voluntarily participate in this study and sign the informed consent form;
  • Age 18-70 years old;
  • Primary debulking surgery for epithelial ovarian cancer (including neoadjuvant chemotherapy), with or without abdominal and distant metastasis (≥ IIB stage);
  • Colonoscopy negative (no mucosal layer invasion);
  • Preoperative imaging (enhanced pelvic MRI) assesses the tumor's involvement of the intestinal surface and/or major parts of the mesentery;
  • Eastern Cooperative Oncology Group (ECOG) score < 3;
  • American Society of Anesthesiologists (ASA) score < 3.

Exclusion Criteria:

  • Has a history of other malignant tumors or is undergoing other anti-tumor treatments;
  • Has severe underlying medical conditions that make surgery intolerable;
  • Epithelial ovarian cancer diagnosed incidentally during emergency surgery;
  • Participates in other clinical studies simultaneously;
  • Secondary cytoreductive surgery for epithelial ovarian cancer;
  • Patients who have received radiotherapy to the abdomen or pelvis before.

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rectosigmoid Lesion Excision
rectosigmoid lesion excision +tumor cell debulking surgery
Procedure: Rectosigmoid Lesion Excision +tumor cell debulking surgery
Surgery for pelvic rectosigmoid tumors
Active Comparator: Rectosigmoid Resection
rectosigmoid resection +tumor cell debulking surgery
Procedure: Rectosigmoid Resection +tumor cell debulking surgery
Rectosigmoid Resection +tumor cell debulking surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-free survival(PFS)
Time Frame: Two years after the surgery
Two years progression-free survival rate will be estimated, and 95% confidence intervals will be calculated.
Two years after the surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Local recurrence rate in the pelvic region(LPR)
Time Frame: Two years after the surgery
The proportion of cases with local recurrence in the pelvic area among the total number of enrolled cases
Two years after the surgery
Overall Survival(OS)
Time Frame: Five years since being included
OS is defined as the time from the date of randomization until death
Five years since being included
Surgical Complications(SC)
Time Frame: Two months after the surgery
It refers to all the cases where the subjects experienced surgery-related complications, including the type, incidence rate, and severity (graded according to CTCAE V5.0)
Two months after the surgery
Ratio of R0
Time Frame: On the day of the surgery
The proportion of cases that underwent R0 resection (complete resection) among the total number of enrolled cases.
On the day of the surgery
Quality of Life(QoL)
Time Frame: Five years after the surgery
All the subjects will complete the quality of life questionnaire within the specified time until the end event occurs.
Five years after the surgery

Collaborators and Investigators

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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Collaborators

Zhejiang Cancer Hospital
Tongji Hospital
Women's Hospital School Of Medicine Zhejiang University
Zhejiang University
Zhejiang Provincial People's Hospital
The Central Hospital of Lishui City
Shaoxing People's Hospital
Ningbo Women & Children's Hospital
Huzhou Central Hospital

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)

January 10, 2024

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 9, 2026

First Submitted That Met QC Criteria

May 29, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 29, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-0804

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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