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

Army Medical University

Status: Unknown

Conditions: Rectal Cancer

Treatments: Device: Laparoscopic surgery; Device: Robot-assisted surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT03597126

RoboticISR

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

robot-assisted ISR

Active Comparator group

Description:

Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic

Treatment:

Device: Robot-assisted surgery

laparoscopic ISR

Active Comparator group

Description:

Patients with low rectal cancer undergo laparosocopic intersphincteric resection

Treatment:

Device: Laparoscopic surgery