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Comparison of Different Surgical Approaches in Female Rectal Cancer.

NCT07189780 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-09-24

No results posted yet for this study

Summary

Mid-to-low rectal cancer exhibits an extremely high incidence rate in China. Currently, the primary treatment approach for mid-to-low rectal cancer remains surgical intervention, with total mesorectal excision (TME) being the mainstream procedure. In male patients, Heald, Chi Pan , Wei Hongbo , and others have proposed different dissection techniques for the anterior rectal wall. Partial or complete preservation of Denonvilliers Fascia (DVF) during conventional TME (as proposed by Heald) has been shown to significantly reduce intraoperative bleeding and improve postoperative urodynamic function, urinary continence, and sexual function . However, these studies focused exclusively on male patients and did not include female subjects.

In our previous research, we proposed that females do not possess an anatomical structure equivalent to the male DVF. Furthermore, compared to entering the dissection plane by incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection, initiating the peritoneal incision precisely at the lowest point of the peritoneal reflection better ensures the integrity of the mesorectum and vaginal structures, reduces intraoperative bleeding, provides a more favorable operative field, and avoids damage to physiological structures while ensuring complete tumor resection, thereby promoting postoperative recovery. Thus, we concluded that this plane represents the optimal surgical dissection plane for the anterior rectal wall during TME in female patients with mid-to-low rectal cancer without anterior wall invasion.

Since our prior study combined anatomical and clinical retrospective research, we have initiated a prospective multicenter randomized controlled trial to further validate these clinical findings. This study aims to demonstrate that entering the dissection plane at the lowest point of the peritoneal reflection during mid-to-low rectal cancer surgery improves prognosis in female patients, providing high-level evidence-based medical support for the adoption of this technique and establishing the optimal surgical approach for female rectal cancer patients.

Conditions

  • Rectal Cancer Surgery

Interventions

PROCEDURE

Surgical approach

Control Group:Incising the peritoneum 0.5-1 cm above the lowest point of the peritoneal reflection to enter the dissection plane. Experimental Group:Incising the peritoneum precisely at the lowest point of the peritoneal reflection (in the rectovesical or rectouterine pouch) to enter the dissection plane.

Sponsors & Collaborators

  • Wuhan TongJi Hospital

    collaborator OTHER

  • Zhejiang Cancer Hospital

    collaborator OTHER

  • Fudan University

    collaborator OTHER

  • First Affiliated Hospital of Wenzhou Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2027-08-31
Completion
2030-08-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07189780 on ClinicalTrials.gov