NCT05933785

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
260

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 2, 2018

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2021

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

June 27, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
Last Updated

March 7, 2024

Status Verified

March 1, 2024

Enrollment Period

3.5 years

First QC Date

June 27, 2023

Last Update Submit

March 5, 2024

Conditions

Rectal Cancer

Outcome Measures

Primary Outcomes (1)

  • anal preservation rate

    No conversion to APR and closure was closed within 1 year after surgery

    1 year after sugery

Secondary Outcomes (2)

  • incidence of Defecation disorders

    6 months after surgery

  • incidence of positive distal resection margin

    30 days after surgery

Study Arms (2)

transanal endoscopic ISR

Procedure: transanal endoscopic ISR

traditional ISR

Interventions

transanal endoscopic ISRPROCEDURE

perform ISR using laparoscopy through transanal port

transanal endoscopic ISR

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patient with low and ultra-low rectal cancer

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ruijin Hospital

Shanghai, 200025, China

Location

Shanghai Minimally Invasive Surgery Center

Shanghai, China

Location

MeSH Terms

Conditions

Rectal Neoplasms

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesRectal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2023

First Posted

July 6, 2023

Study Start

January 2, 2018

Primary Completion

June 30, 2021

Study Completion

May 30, 2023

Last Updated

March 7, 2024

Record last verified: 2024-03

Locations

CN(2)