An interventional study of Pelvic floor peritoneum reconstruction in Rectal Cancer Surgery, Middle and Low Rectal Cancer and Intestinal Obstruction, sponsored by Sun Yat-sen University. Active, not recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-02-25.
Sponsored by Sun Yat-sen University · Not applicable, Interventional, and Treatment
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:
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:
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.
167 studies on the registry are indexed under Ileus; 23 are open to participants now.
This study's planned enrollment of 516 is above the median of 90 across 138 interventional studies indexed under Ileus.
Browse Ileus studies →Sun Yat-sen University is the lead sponsor of 1,690 studies on the registry; 619 are open to participants now.
Compared within Ileus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Intestinal Obstruction. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 pelvic floor peritoneum is left open, and a pelvic drainage tube is placed on the left side.
After laparoscopic radical resection of rectal cancer, the right pelvic floor peritoneum was continuously sutured and closed with 3-0 absorbable sutures.
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
Time frame: Within 30 days after radical resection of rectal cancer
Postoperative recovery indicators
Postoperative recovery indicators included time to first flatus (h), time to first defecation (h), and postoperative length of hospital stay (days).
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 6 months after radical resection of rectal cancer
This study is active, not recruiting, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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