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

Not Applicable

• Conditions: Rectal Cancer
• Interventions: Device: Robot-assisted surgery; Device: Laparoscopic surgery

• Registration Number: NCT03597126
• Lead Sponsor: Southwest Hospital, China

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-04-23
• Study First Submitted QC: 2018-07-13
• Study First Posted: 2018-07-24
• Study Start: 2018-12-01
• Status Verified: 2021-11
• Last Update Submitted: 2021-11-28
• Last Update Posted: 2021-12-09
• Primary Completion: 2022-06-01
• Study Completion: 2022-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
robot-assisted ISR	Robot-assisted surgery	Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic
laparoscopic ISR	Laparoscopic surgery	Patients with low rectal cancer undergo laparosocopic intersphincteric resection

Primary Outcome Measures

Name	Time	Method
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)
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.
Change in urinary function	6 months	The days of indwelling catheter after operation The overall efficiency of urination function
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

Trial Locations

Locations (1)

Southwest Hospital; 🇨🇳 Chongqing, China