Clinical trial · Interventional
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
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Ileus | — | UNRESOLVED | — |
| Intestinal Obstruction | — | UNRESOLVED | — |
| Middle and Low Rectal Cancer | — | UNRESOLVED | — |
| Rectal Cancer Surgery | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pelvic floor peritoneum reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Experimental group
- description
- 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.
- interventionNames
- Procedure: Pelvic floor peritoneum reconstruction
- type
- NO_INTERVENTION
- label
- control group
- description
- 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.
Primary outcomes (1)
- measure
- Incidence of Postoperative Ileus (PPOI)
- timeFrame
- Within 30 days after radical resection of rectal cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (0)
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