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

NCT07432542 | Active Not Recruiting DMC

• 1 other identifier: 2025ZSLYEC-692
• Study Type: interventional
• Target: 516
• Locations: 1 country
• Sites: 1

Brief 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. 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. 2.What is the impact of pelvic floor peritoneal closure on postoperative complications such as anastomotic leakage and pelvic infection?
3. 3.How do the two surgical approaches differ in their effects on patients' postoperative anal function, urinary function, and quality of life?
4. 4.Undergo laparoscopic radical resection with anus preservation for mid-low rectal cancer
5. 5.Receive either pelvic floor peritoneal closure or non-closure treatment based on random assignment
6. 6.Attend regular follow-up visits to evaluate intestinal function recovery and occurrence of complications
7. 7.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

Keywords

rectal cancers; Ileus

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Ileus (PPOI)

  Incidence of Postoperative Ileus (PPOI) = (Number of Patients with PPOI / Total Number of Enrolled Subjects) Postoperative Paralytic Ileus (PPOI) refers to ileus occurring within 30 days post-surgery. Diagnosis requires: 1. Time: ≤30 days post rectal cancer resection. 2. Clinical Symptoms (at least 2 of the following required): Distension, vomiting, no flatus/defecation (≥24h), or absent bowel sounds. 3. Radiological Evidence (at least 1 of the following required): (1) Abdominal X-ray: Multiple air-fluid levels combined with bowel dilatation (small bowel diameter \>3 cm, colon \>6 cm). (2) Abdominal CT: Bowel dilatation combined with transition point (e.g., pelvic adhesion, internal hernia, or bowel loop entrapped in peritoneal defect). 4.Therapeutic Intervention (at least 1 of the following required): 1. NPO (nil per os) and gastrointestinal decompression 2. Intravenous nutritional support for ≥ 48 hours. 3. Surgical exploration to relieve the obstruction

  Within 30 days after radical resection of rectal cancer

Secondary Outcomes (5)

• Postoperative recovery indicators

  up to 2 weeks

• operative time

  Intraoperative period

• intraoperative blood loss

  Intraoperative period

• Postoperative complications

  Within 3 years after radical resection of rectal cancer

• Health-related quality of life

  6 months after radical resection of rectal cancer

Study Arms (2)

Experimental group

EXPERIMENTAL

After laparoscopic radical resection of rectal cancer, the right pelvic floor peritoneum was continuously sutured and closed with 3-0 absorbable sutures, and a pelvic drainage tube was placed on the left side.

Procedure: Pelvic floor peritoneum reconstruction

control group

NO INTERVENTION

After laparoscopic radical resection of rectal cancer, the pelvic floor peritoneum is left open, and a pelvic drainage tube is placed on the left side.

Interventions

Pelvic floor peritoneum reconstruction PROCEDURE

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

Experimental group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age: 18-75 years
• Pathology: Histologically confirmed rectal adenocarcinoma
• Tumor Location: Mid-low rectal cancer (inferior margin ≤10 cm from anal verge)
• Surgical Procedure: Laparoscopic radical resection with sphincter preservation
• Organ Function: Adequate hepatic/renal/cardiopulmonary function
• Informed Consent: Patient/legal guardian comprehends the study and provides written informed consent

You may not qualify if:

• Concurrent or prior history of malignant tumors.
• Miles procedure or Hartmann's operation.
• Intraoperative failure to open the peritoneal reflection.
• Prior pelvic floor surgery.
• Emergency surgery for bowel obstruction.
• Severe hepatic/renal/cardiopulmonary dysfunction, coagulopathy, or underlying diseases contraindicating surgery.
• History of severe psychiatric disorders.
• Pregnancy or lactation.
• Investigator-determined clinical/laboratory contraindications.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 518000, China

Location

MeSH Terms

Conditions

Intestinal Obstruction; Ileus; Rectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chief physician

Model Details: After laparoscopic radical resection for rectal cancer, the right pelvic peritoneum is closed with continuous suturing using 3-0 absorbable sutures, and a pelvic drainage tube is placed on the left side.

Study Record Dates

• First Submitted: January 6, 2026
• First Posted: February 25, 2026
• Study Start: June 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: February 25, 2026

Record last verified: 2026-01

Locations

CN (1)