NCT07432542Active, not recruiting
Pelvic Floor Peritoneal Closure to Prevent Postoperative Ileus in Mid-Low Rectal Cancer Surgery
A Prospective, Multicenter, Randomized, Open-Label, Parallel-Controlled Clinical Study on Pelvic Floor Peritoneal Closure During Laparoscopic Radical Resection of Mid-Low Rectal Cancer for the Prevention of Postoperative Ileus
Source: ClinicalTrials.gov · Last updated 25 Feb 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 516 (estimated)
- First submitted
- 6 Jan 2026
- Start date
- 1 Jun 2025
- Primary completion date
- 31 May 2028
- Lead sponsor
- Sun Yat-sen University
- Diseases
- Colorectal cancer
- NCT number
- NCT07432542
What you commit to
- Study type: Interventional
- Planned participants: 516
- From 1 Jun 2025 to the primary completion date, 31 May 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Prior pelvic floor surgery.
- Emergency surgery for bowel obstruction.
Other illness
- Concurrent or prior history of malignant tumors.
- Intraoperative failure to open the peritoneal reflection.
- Severe hepatic/renal/cardiopulmonary dysfunction, coagulopathy, or underlying diseases contraindicating surgery.
- History of severe psychiatric disorders.
Lab values
- Investigator-determined clinical/laboratory contraindications.
Other
- Miles procedure or Hartmann's operation.
- Pregnancy or lactation.
Who the study is looking for
- 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
- Exclusion of Other Cancers: No concurrent or prior multiple primary malignancies
- Organ Function: Adequate hepatic/renal/cardiopulmonary function
- Informed Consent: Patient/legal guardian comprehends the study and provides written informed consent
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of colorectal surgery, the Sixth Affiliated Hospital, Sun Yat-Sen University Coordinator of this site? Confirm its status | Guangzhou | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.