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

Rectal Cancer Clinical Trial

— R-ISR  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03597126
• Other study ID #: RoboticISR
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: November 2021
• Source: Southwest Hospital, China
• Contact: Tang Bo, M.D
• Phone: +86 13883902288
• Email: yupeiwu1961[@]aliyun.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 1, 2022
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Rectal Cancer
• Rectal Neoplasms

Intervention

Device:
• Robot-assisted surgery
robot-assisted intersphincteric resection for low location rectal cancer(T=1&2)
• Laparoscopic surgery
laparoscopic intersphincteric resection for low location rectal cancer(T=1&2)

Locations

Country	Name	City	State
China	Southwest Hospital	Chongqing

Sponsors (1)

Lead Sponsor	Collaborator
Southwest Hospital, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in urinary function	The days of indwelling catheter after operation The overall efficiency of urination function	6 months
Primary	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)	18 months
Primary	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	18 months
Primary	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.	18 months