Rectal Cancer SurgeryTOWER-1NCT07432542
Pelvic Floor Peritoneal Closure to Prevent Postoperative Ileus in Mid-Low Rectal Cancer Surgery
A study testing Pelvic floor peritoneum reconstruction in people with Rectal Cancer Surgery and Middle and Low Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rectal Cancer Surgery, Middle and Low Rectal Cancer, Intestinal Obstruction
- What is being tested?
- Pelvic floor peritoneum reconstruction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 516 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2025to 31 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- History of severe psychiatric disorders.
- Pregnancy or lactation.
- Investigator-determined clinical/laboratory contraindications.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 518000
About this study
Official title: 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:
- Can closing the pelvic floor peritoneum reduce the incidence of ileus within 30 days after surgery in patients with mid-low rectal cancer?
- What is the impact of pelvic floor peritoneal closure on postoperative complications such as anastomotic leakage and pelvic infection?
- How do the two surgical approaches differ in their effects on patients' postoperative anal function, urinary function, and quality of life?
Read more
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:
- Undergo laparoscopic radical resection with anus preservation for mid-low rectal cancer
- Receive either pelvic floor peritoneal closure or non-closure treatment based on random assignment
- Attend regular follow-up visits to evaluate intestinal function recovery and occurrence of complications
- Complete quality of life questionnaires (EORTC QLQ-C30 scale) at 6 months after surgery
Read the 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.
- Being tested
- Pelvic floor peritoneum reconstruction
- Keywords
- rectal cancers, Ileus
- Medical subject headings
- Intestinal Obstruction, Ileus, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pelvic floor peritoneum reconstructionProcedure or surgery
After laparoscopic radical resection of rectal cancer, the right pelvic floor peritoneum was continuously sutured and closed with 3-0 absorbable sutures.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | 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. Receives: Procedure: Pelvic floor peritoneum reconstruction |
| control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 30 days after radical resection of rectal cancer
Secondary outcomes (5)
Postoperative recovery indicators
Postoperative recovery indicators included time to first flatus (h), time to first defecation (h), and postoperative length of hospital stay (days).
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 6 months after radical resection of rectal cancer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start1 Jun 2025
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal Cancer SurgeryStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- After laparoscopic radical resection for rectal cancer, the right pelvic peritoneum is closed with continuous suturing using 3-0 absorbable sutures, and a pelvic drainage tube is placed on the left side.
- Masking
- None (open label)
- Enrolment
- 516 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07432542
- Sponsor's protocol ID
- 2025ZSLYEC-692
- Acronym
- TOWER-1
- Status last verified
- Jan 2026
- First submitted
- 6 Jan 2026
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07432542
- Acronym / sponsor ID
- TOWER-1 / 2025ZSLYEC-692
- Keywords
- rectal cancers, Ileus
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 516 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 May 2028 (estimated)
- Study completion
- 31 May 2028 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can closing the pelvic floor peritoneum reduce the incidence of ileus within 30 days after surgery in patients with mid-low rectal cancer?
- What is the impact of pelvic floor peritoneal closure on postoperative complications such as anastomotic leakage and pelvic infection?
- 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:
- Undergo laparoscopic radical resection with anus preservation for mid-low rectal cancer
- Receive either pelvic floor peritoneal closure or non-closure treatment based on random assignment
- Attend regular follow-up visits to evaluate intestinal function recovery and occurrence of complications
- Complete quality of life questionnaires (EORTC QLQ-C30 scale) at 6 months after surgery
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- After laparoscopic radical resection for rectal cancer, the right pelvic peritoneum is closed with continuous suturing using 3-0 absorbable sutures, and a pelvic drainage tube is placed on the left side.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Pelvic floor peritoneum reconstructionAfter 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. |
| control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pelvic floor peritoneum reconstructionAfter laparoscopic radical resection of rectal cancer, the right pelvic floor peritoneum was continuously sutured and closed with 3-0 absorbable sutures. | Procedure or surgery | Experimental group |
Primary outcome
Incidence of Postoperative Ileus (PPOI)
Time frame: Within 30 days after radical resection of rectal cancer
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
5 secondary outcomes
Postoperative recovery indicators
Time frame: up to 2 weeks
operative time
Time frame: Intraoperative period
intraoperative blood loss
Time frame: Intraoperative period
Postoperative complications
Time frame: Within 3 years after radical resection of rectal cancer
Health-related quality of life
Time frame: 6 months after radical resection of rectal cancer
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pelvic floor peritoneum reconstruction in people with Rectal Cancer Surgery and Middle and Low Rectal Cancer, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 25 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Ileus (PPOI) (time frame: Within 30 days after radical resection of rectal cancer). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2026.