Intraoperative Rectal Lavage to Prevent Local Recurrence After Laparoscopic Mid-to-Low Rectal Cancer Resection: A Multicenter Randomized Trial (TOWER-2)

March 30, 2026 updated by: Yanhong Deng, Sun Yat-sen University

Laparoscopic Rectal Irrigation for the Prevention of Local Recurrence After Radical Resection of Mid-to-Low Rectal Cancer: A Prospective, Multicenter, Randomized, Open-label, Parallel-controlled Clinical Study

Brief Summaries Trial Purpose The primary objective of this prospective, randomized, multicenter, open-label, parallel-controlled clinical trial is to evaluate whether intraoperative rectal irrigation during laparoscopic radical resection of low-to-mid rectal cancer reduces postoperative local recurrence rates compared to no irrigation. Secondary objectives include assessing overall survival, incidence of postoperative complications (e.g., anastomotic leakage, stenosis), and quality of life at 6 months (EORTC QLQ-C30 scale).

Participants Will:

  • Undergo laparoscopic radical resection with or without rectal irrigation (based on randomization);
  • Follow standardized Enhanced Recovery After Surgery (ERAS) protocols postoperatively;
  • Attend scheduled follow-ups at 3, 6, 12, 24, 36, and 60 months post-surgery, including clinical evaluations, imaging (CT/MRI), laboratory tests (CEA), and questionnaire assessments;
  • Maintain a symptom diary and record rescue inhaler usage (if applicable).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

This prospective, multicenter, randomized, open-label, parallel-controlled clinical trial aims to evaluate the efficacy of intraoperative rectal lavage in preventing local recurrence after laparoscopic radical resection for mid-to-low rectal cancer. Despite significant improvements in rectal cancer outcomes through standardized total mesorectal excision (TME) techniques and neoadjuvant therapy, local recurrence remains a serious clinical challenge with poor prognosis. Evidence suggests that exfoliated tumor cells within the bowel lumen may contribute to anastomotic seeding and subsequent local recurrence. Intraoperative manipulation of the tumor and use of circular staplers during anastomosis may further increase the risk of tumor cell dissemination. Rectal lavage represents a potential strategy to eliminate these free intraluminal malignant cells through mechanical flushing and/or cytotoxic effects of lavage solutions.

The study will enroll approximately 1,598 patients (accounting for a 10% dropout rate) across multiple centers in China. Participants must be 18-75 years of age with histologically confirmed adenocarcinoma of the rectum, where the tumor's distal margin is located within 10 cm of the anal verge. All patients must be scheduled to undergo laparoscopic radical resection with sphincter preservation. Key exclusion criteria include history of other malignancies, abdominoperineal resection (Miles procedure) or Hartmann's procedure, emergency surgery for bowel obstruction, severe organ dysfunction contraindicating surgery, pregnancy or lactation, and serious psychiatric disorders.

Eligible participants will be randomly assigned to either the experimental group (rectal lavage with normal saline/povidone-iodine solution) or the control group (no rectal lavage). Both groups will receive standardized laparoscopic TME procedures performed by experienced surgical teams, followed by identical Enhanced Recovery After Surgery (ERAS) protocols. The primary endpoint is the rate of local recurrence. Secondary endpoints include overall survival, incidence of postoperative complications (anastomotic leakage, pelvic infection, wound infection, intra-abdominal hemorrhage, urinary tract infection) graded according to the Clavien-Dindo classification system, and quality of life at 6 months postoperatively assessed using the EORTC QLQ-C30 questionnaire.

Participants will undergo scheduled follow-up assessments at 3, 6, 12, 24, 36, and 60 months after surgery, including clinical evaluations, imaging studies (CT/MRI), laboratory tests (CEA levels), and quality of life questionnaires. The study hypothesizes that the local recurrence rate will be 6% in the rectal lavage group compared to 10% in the control group. With a two-sided alpha of 0.05 and 80% statistical power, this sample size will provide adequate power to detect this clinically significant difference. This investigation will provide high-quality evidence regarding the role of intraoperative rectal lavage in preventing local recurrence after laparoscopic resection of mid-to-low rectal cancer, potentially establishing a simple yet effective intervention to improve oncological outcomes in this patient population.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1598

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 18 and 75 years old.
  • Pathologically confirmed rectal adenocarcinoma.
  • Mid-to-low rectal cancer with the tumor lower margin located ≤10 cm from the anal verge.
  • Underwent laparoscopic radical resection for rectal cancer with sphincter preservation.
  • Without concomitant multiple primary malignancies.
  • Adequate organ function.
  • Patients or their family members were able to understand the study protocol, willing to participate in this study, and provided written informed consent.

Exclusion Criteria:

  • Concomitant other malignancies or a history of prior malignancies.
  • Abdominal perineal resection (Miles' operation) or Hartmann's procedure.
  • Failure to open the peritoneal reflection during surgery.
  • History of previous pelvic floor surgery.
  • Emergency surgery due to bowel obstruction.
  • Severe hepatic, renal, cardiopulmonary, or coagulation dysfunction, or other severe comorbidities that render the patient unable to tolerate the procedure.
  • History of severe psychiatric disorders.
  • Pregnant or lactating women.
  • Any other clinical or laboratory conditions considered unsuitable for participation in the trial by the investigators.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Laparoscopic radical resection for rectal cancer followed by irrigation of the rectal cavity with normal saline / povidone-iodine
Procedure: Rectal irrigation
Laparoscopic radical resection for rectal cancer followed by irrigation of the rectal cavity with normal saline / povidone-iodine
No Intervention: control group
No irrigation of the rectal stump was performed after laparoscopic radical resection for rectal cancer.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Postoperative local recurrence rate
Time Frame: Within 3 years after radical resection of rectal cancer
The postoperative local recurrence rate following laparoscopic radical resection for mid-to-low rectal cancer is defined as the number of patients with recurrence divided by the total number of subjects.
Within 3 years after radical resection of rectal cancer

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Postoperative complications
Time Frame: Within 3 years after radical resection of rectal cancer
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
Postoperative overall survival
Time Frame: Within 3 years after radical resection of rectal cancer
Postoperative Overall Survival (OS) is defined as the length of time from the date of surgery to the date of death from any cause.
Within 3 years after radical resection of rectal cancer
Health-related quality of life at 6 months
Time Frame: Within 3 years after radical resection of rectal cancer
Health-related quality of life at 6 months postoperatively was assessed using the EORTC QLQ-C30 questionnaire.
Within 3 years after radical resection of rectal cancer

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 30, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 6, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2026ZSLYEC-159

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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