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Pelvic Floor Peritoneal Closure to Prevent Postoperative Ileus in Mid-Low Rectal Cancer Surgery

NCT07432542 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 516

Last updated 2026-02-25

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether closing the pelvic floor peritoneum during laparoscopic radical resection of mid-low rectal cancer can reduce the incidence of postoperative ileus. This study will also assess the impact of pelvic floor peritoneal closure on patient recovery and quality of life after surgery. The main questions it aims to answer are:

1. Can closing the pelvic floor peritoneum reduce the incidence of ileus within 30 days after surgery in patients with mid-low rectal cancer?
2. What is the impact of pelvic floor peritoneal closure on postoperative complications such as anastomotic leakage and pelvic infection?
3. How do the two surgical approaches differ in their effects on patients' postoperative anal function, urinary function, and quality of life?

Researchers will compare two approaches after laparoscopic radical resection for rectal cancer: closing the pelvic floor peritoneum versus not closing it, to observe which method more effectively prevents postoperative ileus.

Participants will:

1. Undergo laparoscopic radical resection with anus preservation for mid-low rectal cancer
2. Receive either pelvic floor peritoneal closure or non-closure treatment based on random assignment
3. Attend regular follow-up visits to evaluate intestinal function recovery and occurrence of complications
4. Complete quality of life questionnaires (EORTC QLQ-C30 scale) at 6 months after surgery

Conditions

  • Rectal Cancer Surgery
  • Middle and Low Rectal Cancer
  • Intestinal Obstruction
  • Ileus

Interventions

PROCEDURE

Pelvic floor peritoneum reconstruction

After laparoscopic radical resection of rectal cancer, the right pelvic floor peritoneum was continuously sutured and closed with 3-0 absorbable sutures.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-01
Primary Completion
2028-05-31
Completion
2028-05-31

Countries

  • China

Study Locations

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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 NCT07432542 on ClinicalTrials.gov