Pelvic Floor Peritoneal Closure to Prevent Postoperative Ileus in Mid-Low Rectal Cancer Surgery (TOWER-1)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Ileus; Intestinal Obstruction; Rectal Cancer Surgery; Middle and Low Rectal Cancer
• Intervention / Treatment: Procedure: Pelvic floor peritoneum reconstruction

Detailed Description

This prospective, multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy of pelvic floor peritoneal closure in preventing postoperative ileus following laparoscopic radical resection for mid-low rectal cancer. The study is designed as a superiority trial with a target enrollment of 516 patients across multiple tertiary medical centers in China, including the Sixth Affiliated Hospital of Sun Yat-sen University and collaborating institutions.

The study protocol employs a computer-generated randomization sequence (using RandomAlloc software) with allocation concealment to assign eligible participants to either the intervention group (pelvic peritoneal closure using continuous 3-0 absorbable sutures) or the control group (non-closure of pelvic peritoneum). Both groups will receive a pelvic drainage tube on the left side, and all surgical procedures will be performed by experienced surgical teams using standardized laparoscopic TME (total mesorectal excision) techniques.

The primary endpoint is the incidence of prolonged postoperative ileus (PPOI) within 30 days after surgery, defined as intestinal obstruction requiring medical intervention (nasogastric decompression, parenteral nutrition for ≥48 hours, or surgical exploration) with radiological confirmation and specific clinical symptoms. Secondary endpoints include postoperative recovery parameters (time to first flatus/defecation, length of hospital stay), surgical metrics (operation time, intraoperative blood loss), postoperative complications assessed using the Clavien-Dindo classification system, and quality of life evaluation at 6 months postoperatively using the EORTC QLQ-C30 questionnaire.

Sample size calculation was based on an estimated PPOI rate of 12% in the control group and 5% in the intervention group, with a one-sided alpha of 0.025, 80% power, and accounting for a 5% dropout rate. Statistical analysis will follow both intention-to-treat (ITT) and per-protocol (PP) principles, with appropriate methods for different data types (t-tests for continuous variables, chi-square tests for categorical variables, and Kaplan-Meier analysis with Log-rank test for time-to-event outcomes).

An interim analysis is planned after approximately 260 patients have been enrolled to evaluate study progress and preliminary efficacy results, with pre-specified stopping rules based on statistical significance after alpha adjustment. Data management follows rigorous quality control procedures, including dual data entry, systematic verification, and secure database locking protocols. All participants will be followed for 3 years from the time of enrollment, with the study period spanning from June 2025 to June 2028.

This investigation addresses a significant clinical controversy in minimally invasive colorectal surgery. While pelvic peritoneal reconstruction has been standard in open rectal cancer surgery, its role in laparoscopic approaches remains uncertain due to technical challenges and limited high-quality evidence. By providing level I evidence through a rigorous randomized controlled design, this study aims to establish clear clinical practice guidelines for pelvic floor management in laparoscopic rectal cancer surgery, potentially reducing postoperative morbidity and improving patient outcomes.

• Study Type: Interventional
• Enrollment (Estimated): 516
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 518000
      • Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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; After laparoscopic radical resection of rectal cancer, the right pelvic floor peritoneum was continuously sutured and closed with 3-0 absorbable sutures.
No Intervention: control group; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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: Time: ≤30 days post rectal cancer resection.; Clinical Symptoms (at least 2 of the following required): Distension, vomiting, no flatus/defecation (≥24h), or absent bowel sounds.; 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): NPO (nil per os) and gastrointestinal decompression; Intravenous nutritional support for ≥ 48 hours.; Surgical exploration to relieve the obstruction	Within 30 days after radical resection of rectal cancer

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative recovery indicators	Postoperative recovery indicators included time to first flatus (h), time to first defecation (h), and postoperative length of hospital stay (days).	up to 2 weeks
operative time	Operative time refers to the total duration from the start of the surgical incision (or the beginning of the invasive procedure) to the completion of wound closure.	Intraoperative period
intraoperative blood loss	Intraoperative blood loss refers to the amount of blood lost during a surgical procedure, from the time the incision is made until the wound is closed	Intraoperative period
Postoperative complications	Postoperative complications-including anastomotic leakage, pelvic infection, surgical site infection, intra-abdominal hemorrhage, urinary tract infection, etc.-were graded according to the Clavien-Dindo classification system.	Within 3 years after radical resection of rectal cancer
Health-related quality of life	Health-related quality of life at 6 months postoperatively was assessed using the EORTC QLQ-C30 questionnaire.	6 months after radical resection of rectal cancer

Collaborators and Investigators

• Sponsor: Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028

Study Registration Dates

• First Submitted: January 6, 2026
• First Submitted That Met QC Criteria: February 23, 2026
• First Posted (Actual): February 25, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 23, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Ileus; rectal cancers
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Intestinal Diseases; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colorectal Neoplasms; Intestinal Neoplasms; Rectal Diseases; Rectal Neoplasms; Ileus; Intestinal Obstruction
• Other Study ID Numbers: 2025ZSLYEC-692

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No