Pelvic Floor Peritoneal Closure to Prevent Postoperative Ileus in Mid-Low Rectal Cancer Surgery (NCT07432542) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Pelvic Floor Peritoneal Closure to Prevent Postoperative Ileus in Mid-Low Rectal Cancer Surgery
China516 participantsStarted 2025-06-01
Plain-language 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
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Postoperative Ileus (PPOI)
Timeframe: Within 30 days after radical resection of rectal cancer