Using transanal irrigation to prevent bowel dysfunction after rectal cancer surgery
A Prospective, Randomized, Open, Parallel Trial of Transanal Irrigation to Prevent Major Low Anterior Resection Syndrome in Rectal Cancer Patients
This study tests if using transanal irrigation can help prevent bowel problems in people who have had surgery for rectal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT04758195 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the effectiveness of transanal irrigation (TAI) in preventing major low anterior resection syndrome (LARS) in patients who have undergone curative low anterior resection for rectal cancer. Participants will be randomly assigned to receive either TAI or best supportive treatment after their stoma is reversed. The primary outcome measured will be the occurrence of major LARS six months post-treatment. The study aims to provide insights into the preventive role of TAI in managing bowel dysfunction following rectal cancer surgery.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-75 who have undergone curative low anterior resection for rectal cancer and have had their diverting stoma closed within the last month.
Not a fit: Patients with tumor recurrence, severe comorbidities, or prior conditions affecting bowel function may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of major LARS and improve the quality of life for patients recovering from rectal cancer surgery.
How similar studies have performed: While transanal irrigation has shown promise in managing bowel dysfunction, this specific preventive approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age: 18-75 years old * Curative low anterior resection for rectal cancer with diverting stoma * Stoma closure within 1 month * Preoperative radiotherapy or height of anastomosis less than 5 cm from anal verge * No evidence of anastomotic leakage or severe stenosis Exclusion Criteria: * Tumor recurrence or distant metastasis * Secondary operation with stoma * Prior disease impairing bowel function except for rectal cancer * Any contraindication for transanal irrigation * Pregnant or nursing * Serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease * Cognitive or psychological disorder
Where this trial is running
Guangzhou, Guangdong
- Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Qiyuan Qin, M.D. — The Sixth Affiliated Hospital, Sun Yat-sen University
- Study coordinator: Qiyuan Qin, M.D.
- Email: qinqy3@mail.sysu.edu.cn
- Phone: 86-20-38254052
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.