Actively Recruiting
Utilization of Transanal Endoscopy in the Treatment of Anastomotic Stenosis
Led by Sun Yat-sen University · Updated on 2023-09-14
50
Participants Needed
1
Research Sites
178 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Severe rectal anastomotic stenosis can not only cause intestinal obstruction, but also be accompanied by frequent defecation, which affects the quality of life, and patients face the outcome of permanent stoma or temporary stoma again. Traditional transabdominal resection and reconstruction of rectal anastomotic stenosis is more likely to occur due to unclear anatomical structure, dense scars around the intestinal canal, complications such as ureteral and urethral injury and massive presacral hemorrhage. In addition,41%of patients with anastomotic stenosis who underwent reoperation through abdominal surgery had anastomotic leakage again, and up to 30% of patients could not close the stoma. The advantages of transanal total mesorectal excision (taTME) using a transanal approach for total mesorectal excision in the treatment of middle and low rectal cancer with difficult pelvis have been demonstrated by our group. However, taTME has rarely been explored in the treatment of anastomotic stenosis. Our team retrospectively summarized the patients who underwent transabdominal transanal endoscopic resection and reconstruction of anastomotic stenosis (l-taTME), and initially demonstrated the safety and effectiveness of this surgical method, with a stoma closure rate of 90%. Although the advantages of l-taTME in the treatment of severe rectal anastomotic stenosis are obvious in theory and preliminary clinical practice, there is a lack of prospective studies. Therefore, the investigators plan to conduct a prospective clinical study to observe the safety and efficacy of l-taTME reconstruction surgery, and to provide high-level evidence-based medical basis for the selection of resection and reconstruction surgery for patients with rectal anastomotic stenosis.
CONDITIONS
Official Title
Utilization of Transanal Endoscopy in the Treatment of Anastomotic Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age of 18-70 years old
- ECOG performance status score 0-2
- Previous rectal resection
- Diagnosed with middle and low rectal anastomotic tubular stenosis
- Able to tolerate general anesthesia
- Able to understand the study and willing to participate with informed consent
You will not qualify if you...
- Acute intestinal obstruction, perforation, or bleeding needing emergency surgery
- Severe pelvic adhesion or frozen pelvis
- Unstable primary tumors or tumors at other sites
- Previous left hemicolectomy
- ASA grade IV to V
- Combined organ resection
- Severe mental illness
- Pregnant or breastfeeding women
- Severe cardiovascular disease, uncontrolled infection, or other uncontrolled conditions
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Sixth Affiliated Hospital of Sun yat-sen University
Guangzhou, Guangdong, China
Actively Recruiting
Research Team
L
Liang Huang, Doctor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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