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

Primary Purpose

Rectal Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Robot-assisted surgery
Laparoscopic surgery
Sponsored by
Southwest Hospital, China
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Cancer focused on measuring Robotic, Intersphincteric Resection, rectal cancer, pelvic autonomic nerve anal function

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Southwest HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

robot-assisted ISR

laparoscopic ISR

Arm Description

Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic

Patients with low rectal cancer undergo laparosocopic intersphincteric resection

Outcomes

Primary Outcome Measures

Change in urinary function
The days of indwelling catheter after operation The overall efficiency of urination function
Change in International Index of Erectile Function [IIEF] score
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)
Change in FIQL scores
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
Change in Female Sexual Function Index [FSFI]
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.

Secondary Outcome Measures

Full Information

First Posted
April 23, 2018
Last Updated
November 28, 2021
Sponsor
Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03597126
Brief Title
Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer
Acronym
R-ISR
Official Title
Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer:A Multicentric Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2021
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
December 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Southwest Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rectal Cancer
Keywords
Robotic, Intersphincteric Resection, rectal cancer, pelvic autonomic nerve anal function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
robot-assisted ISR
Arm Type
Active Comparator
Arm Description
Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic
Arm Title
laparoscopic ISR
Arm Type
Active Comparator
Arm Description
Patients with low rectal cancer undergo laparosocopic intersphincteric resection
Intervention Type
Device
Intervention Name(s)
Robot-assisted surgery
Intervention Description
robot-assisted intersphincteric resection for low location rectal cancer(T=1&2)
Intervention Type
Device
Intervention Name(s)
Laparoscopic surgery
Intervention Description
laparoscopic intersphincteric resection for low location rectal cancer(T=1&2)
Primary Outcome Measure Information:
Title
Change in urinary function
Description
The days of indwelling catheter after operation The overall efficiency of urination function
Time Frame
6 months
Title
Change in International Index of Erectile Function [IIEF] score
Description
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)
Time Frame
18 months
Title
Change in FIQL scores
Description
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
Time Frame
18 months
Title
Change in Female Sexual Function Index [FSFI]
Description
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.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years < age < 80 years Matching the diagnostic criteria; tumor located 3 cm from anal verge Clinically diagnosed cT1-3N0-2 M0 lesions Tumor size of 4 cm or less ASA 1-3 scores; ECOG score is 0-1; Adequate preoperative sphincter function Exclusion Criteria: Requiring a Mile's procedure Fecal incontinence; Previous abdominal surgery Severe mental disease. Intolerance of surgery for severe comorbidities Emergency operation due to complication Pregnant woman or lactating woman
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tang Bo, M.D
Phone
+86 13883902288
Email
yupeiwu1961@aliyun.com
First Name & Middle Initial & Last Name or Official Title & Degree
Li Chuan, M.D
Phone
+86-18323479228
Email
lee_tran@126.com
Facility Information:
Facility Name
Southwest Hospital
City
Chongqing
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yu Yupeiwu, M.D/Ph.D
Phone
+8618323479228
Email
yupeiwu01@sina.com

12. IPD Sharing Statement

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Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer

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