Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer (R-ISR)

November 28, 2021 updated by: Li Chuan, Southwest Hospital, China

Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer:A Multicentric Randomized Controlled Trial

This study compared robot-assisted total mesorectal excision to treat very low rectal cancer within 2 cm from the dentate line to avoid permanent colostomy. improves the quality of life with better defecation function, urinary function and sexual function.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • China
      • Chongqing, China
        • Recruiting
        • Southwest Hospital
        • Contact:

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

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. 18 years < age < 80 years
  2. Matching the diagnostic criteria;
  3. tumor located 3 cm from anal verge
  4. Clinically diagnosed cT1-3N0-2 M0 lesions
  5. Tumor size of 4 cm or less
  6. ASA 1-3 scores;
  7. ECOG score is 0-1;
  8. Adequate preoperative sphincter function

Exclusion Criteria:

  1. Requiring a Mile's procedure
  2. Fecal incontinence;
  3. Previous abdominal surgery
  4. Severe mental disease.
  5. Intolerance of surgery for severe comorbidities
  6. Emergency operation due to complication
  7. Pregnant woman or lactating woman

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: robot-assisted ISR
Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic
Device: Robot-assisted surgery
robot-assisted intersphincteric resection for low location rectal cancer(T=1&2)
Active Comparator: laparoscopic ISR
Patients with low rectal cancer undergo laparosocopic intersphincteric resection
Device: Laparoscopic surgery
laparoscopic intersphincteric resection for low location rectal cancer(T=1&2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in urinary function
Time Frame: 6 months
The days of indwelling catheter after operation The overall efficiency of urination function
6 months
Change in International Index of Erectile Function [IIEF] score
Time Frame: 18 months
Alterations in IIEF scores from baseline up to 18 months postoperatively - 15 item questionnaire, each item range from 0 - 5, with total score to 30. lower score indicates more severe erectile dysfunction (ED)
18 months
Change in FIQL scores
Time Frame: 18 months
Alterations in Fecal Incontinence Quality of Life Instrument (FIQL) scores from baseline up to 18 months postoperatively - 29 items range from 1 (strongly agree) to 4 (strongly disagree); with a 1 indicating a lower functional status of quality of life. Scale scores are only calculated if at least half of the items have been answered
18 months
Change in Female Sexual Function Index [FSFI]
Time Frame: 18 months
Alterations in FSFI from baseline up to 18 months postoperatively - 19-item self-report measure, each item ranges from 0-5, with full range from 2 to 36, with low score indicating sexual function disorder.
18 months

Collaborators and Investigators

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

Sponsor

Southwest Hospital, China

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)

December 1, 2018

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

December 1, 2022

Study Registration Dates

First Submitted

April 23, 2018

First Submitted That Met QC Criteria

July 13, 2018

First Posted (Actual)

July 24, 2018

Study Record Updates

Last Update Posted (Actual)

December 9, 2021

Last Update Submitted That Met QC Criteria

November 28, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RoboticISR

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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