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

• Sponsor: Southwest Hospital, China (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT03597126
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 48
• Patients Per Site Per Month: 2.1

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Rectal Cancer	Device: Robot-assisted surgery; Device: Laparoscopic surgery	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Short Term Outcomes of Robotic-assisted Intersphincteric Resection for Low Rectal Cancer:A Multicentric Randomized Controlled Trial
• Actual Study Start Date: Dec 1, 2018
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures

1. Change in urinary function [6 months]

   The days of indwelling catheter after operation The overall efficiency of urination function

2. Change in International Index of Erectile Function [IIEF] score [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)

3. Change in FIQL scores [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

4. Change in Female Sexual Function Index [FSFI] [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Southwest Hospital	Chongqing		China

Sponsors and Collaborators

• Southwest Hospital, China

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Li Chuan, Principal Investigator, Southwest Hospital, China
• ClinicalTrials.gov Identifier: NCT03597126
• Other Study ID Numbers: RoboticISR
• First Posted: Jul 24, 2018
• Last Update Posted: Dec 9, 2021
• Last Verified: Nov 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Li Chuan, Principal Investigator, Southwest Hospital, China: Robotic; Intersphincteric Resection; rectal cancer; pelvic autonomic nerve anal function
• Additional relevant MeSH terms: Rectal Neoplasms

Study Results

No Results Posted as of Dec 9, 2021