the Value of Transanal Endoscopic ISR

March 5, 2024 updated by: Shanghai Minimally Invasive Surgery Center

The Value of Transanal Endoscopic Intersphincteric Resection (taE-ISR) in Extreme Anal Preservation in Ultra-low Rectal Cancer

The Intersphincteric resection (ISR) technique is an alternative for anal preservation in ultra-low rectal cancer. The transanal total mesorectal excision (TaTME) technique might compensate for the deficiencies of ISR in terms of tumor spillage and poor surgical field exposure. Thus, the investigators perform ISR through a transanal endoscopic approach (taE-ISR), seeking to evaluate the value of this innovative technique in anal preservation in ultra-low rectal cancer.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

260

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 200025
        • Ruijin Hospital
      • Shanghai, China
        • Shanghai Minimally Invasive Surgery Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

patient with low and ultra-low rectal cancer

Description

Inclusion Criteria:

  • Age between 18 and 75 years
  • American Society of Anesthesiologists (ASA) score I to III
  • A biopsy proven histological diagnosis of rectal carcinoma
  • preoperative stage as (y) cT1-3N0-2M0
  • lower margin of the tumor less than 5cm from the anus
  • tumor diameter ≤5cm

Exclusion Criteria:

  • Pregnant or lactating women
  • Synchronous rectal carcinoma
  • History of colorectal cancer or other malignant tumors
  • Clinical evidence of metastasis
  • Emergency procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
transanal endoscopic ISR
Procedure: transanal endoscopic ISR
perform ISR using laparoscopy through transanal port
traditional ISR

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
anal preservation rate
Time Frame: 1 year after sugery
No conversion to APR and closure was closed within 1 year after surgery
1 year after sugery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
incidence of Defecation disorders
Time Frame: 6 months after surgery
A Wexner score >10 indicated the existence of defecation dysfunction
6 months after surgery
incidence of positive distal resection margin
Time Frame: 30 days after surgery
A positive distal resection margin (DRM) was diagnosed with the presence of tumor cells within 1mm from the DRM
30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Minimally Invasive Surgery Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 2, 2018

Primary Completion (Actual)

June 30, 2021

Study Completion (Actual)

May 30, 2023

Study Registration Dates

First Submitted

June 27, 2023

First Submitted That Met QC Criteria

June 27, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • taE-ISR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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