Using transanal endoscopy to treat rectal anastomotic stenosis
A Prospective Clinical Study of Transanal and Transabdominal Combined Endoscopic Resection of Rectal Stenosis and Anal Reconstruction for Severe Rectal Anastomotic Stenosis
This study is testing a new way to treat narrowing in the rectum after surgery to see if it can help patients feel better and avoid more serious complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06036862 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of transanal total mesorectal excision (taTME) combined with transabdominal techniques to treat anastomotic stenosis following rectal surgery. The approach aims to address complications such as intestinal obstruction and improve the quality of life for patients suffering from this condition. By utilizing a minimally invasive technique, the study seeks to reduce the risks associated with traditional surgical methods, such as anastomotic leakage and the need for stoma formation. Participants will undergo a procedure that involves endoscopic resection of the stenosis and anal reconstruction.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18-70 who have previously undergone rectal resection and are diagnosed with middle and low rectal anastomotic tubular stenosis.
Not a fit: Patients with acute intestinal obstruction, severe pelvic adhesion, or those with unstable primary tumors are unlikely to benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve the management of anastomotic stenosis, enhancing patient outcomes and quality of life.
How similar studies have performed: While the use of taTME has shown promise in treating rectal cancer, its application for anastomotic stenosis is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age of 18-70 years old; 2. ECOG performance status score 0-2; 3. previous rectal resection; 4. patients diagnosed with middle and low rectal anastomotic tubular stenosis; 5. can tolerate general anesthesia; 6. The subjects and their family members, who could understand the study protocol and were willing to participate, signed the informed consent form. Exclusion Criteria: 1. patients with acute intestinal obstruction, intestinal perforation or intestinal bleeding requiring emergency surgery; 2. severe pelvic adhesion and frozen pelvis; 3. patients with unstable primary tumors or combined with tumors at other sites; 4. previous history of left hemicolectomy; 5. ASA grade IV to V; 6. combined organ resection; 7. severe mental illness; 8. pregnant or lactating women; 9. severe cardiovascular disease, uncontrolled infection or other uncontrolled comorbidities;
Where this trial is running
Guangzhou, Guangdong
- Sixth Affiliated Hospital of Sun yat-sen University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Yanhong Deng, Doctor — Sun Yat-sen University
- Study coordinator: Liang Huang, Doctor
- Email: huangl75@mail.sysu.edu.cn
- Phone: 15989101216
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.