Middle and Low Rectal CancerTOWER-2NCT07512232
Intraoperative Rectal Lavage to Prevent Local Recurrence After Laparoscopic Mid-to-Low Rectal Cancer Resection: A Multicenter Randomized Trial
A study testing Rectal irrigation in people with Middle and Low Rectal Cancer and Rectal Cancer Surgery, run by Sun Yat-sen University at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Middle and Low Rectal Cancer, Rectal Cancer Surgery
- What is being tested?
- Rectal irrigation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,598 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 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Colorectal Surgery, The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 518000
Liang Huang, Doctor, 13612929488, huangl75@sysu.edu.cn
About this study
Official title: 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).
Read the 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.
- Being tested
- Rectal irrigation
- Keywords
- rectal cancer, rectal Lavage
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rectal irrigationProcedure or surgery
Laparoscopic radical resection for rectal cancer followed by irrigation of the rectal cavity with normal saline / povidone-iodine
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Laparoscopic radical resection for rectal cancer followed by irrigation of the rectal cavity with normal saline / povidone-iodine Receives: Procedure: Rectal irrigation |
| control group | No intervention | No irrigation of the rectal stump was performed after laparoscopic radical resection for rectal cancer. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative local recurrence rate
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.
Measured: Within 3 years after radical resection of rectal cancer
Secondary outcomes (3)
Postoperative overall survival
Postoperative Overall Survival (OS) is defined as the length of time from the date of surgery to the date of death from any cause.
Measured: Within 3 years after radical resection of rectal cancer
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 at 6 months
Health-related quality of life at 6 months postoperatively was assessed using the EORTC QLQ-C30 questionnaire.
Measured: Within 3 years 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 posted6 Apr 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 Middle and Low Rectal CancerStudies 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
- Intraoperative rectal lavage with normal saline or povidone-iodine during laparoscopic radical resection for rectal cancer
- Masking
- None (open label)
- Enrolment
- 1,598 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
- NCT07512232
- Sponsor's protocol ID
- 2026ZSLYEC-159
- Acronym
- TOWER-2
- Status last verified
- Mar 2026
- First submitted
- 30 Mar 2026
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07512232
- Acronym / sponsor ID
- TOWER-2 / 2026ZSLYEC-159
- Keywords
- rectal cancer, rectal Lavage
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 1,598 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
- 6 Apr 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.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Intraoperative rectal lavage with normal saline or povidone-iodine during laparoscopic radical resection for rectal cancer
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Procedure: Rectal irrigationLaparoscopic radical resection for rectal cancer followed by irrigation of the rectal cavity with normal saline / povidone-iodine |
| control group | No intervention | –No irrigation of the rectal stump was performed after laparoscopic radical resection for rectal cancer. |
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 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.
Key exclusion criteria (9 listed)
- 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.
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 |
|---|---|---|
| Rectal irrigationLaparoscopic radical resection for rectal cancer followed by irrigation of the rectal cavity with normal saline / povidone-iodine | Procedure or surgery | Experimental group |
Primary outcome
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.
3 secondary outcomes
Postoperative overall survival
Time frame: Within 3 years after radical resection of rectal cancer
Postoperative complications
Time frame: 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
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 6 Apr 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rectal irrigation in people with Middle and Low Rectal Cancer and Rectal Cancer Surgery, 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: looking for participants now, as of the sponsor's last update on 6 Apr 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?
Contact Liang Huang, Doctor (+86 15989101216, huangl75@sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative local recurrence rate (time frame: Within 3 years 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 6 Apr 2026.