Actively Recruiting

Phase Not Applicable
Age: 18Years - 70Years
All Genders
NCT06036862

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

Age: 18Years - 70Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Sixth Affiliated Hospital of Sun yat-sen University

Guangzhou, Guangdong, China

Actively Recruiting

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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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