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

Study Overview
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Brief Summary
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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.

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

Conditions
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Rectal Cancer

Intervention / Treatment
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* Device: Robot-assisted surgery
* Device: Laparoscopic surgery


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: robot-assisted ISR<br>Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic | Device: Robot-assisted surgery<br>* robot-assisted intersphincteric resection for low location rectal cancer(T=1&2)<br>|
| Active Comparator: laparoscopic ISR<br>Patients with low rectal cancer undergo laparosocopic intersphincteric resection | Device: Laparoscopic surgery<br>* laparoscopic intersphincteric resection for low location rectal cancer(T=1&2)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in urinary function | The days of indwelling catheter after operation The overall efficiency of urination function | 6 months | 
| 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 | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Robotic, Intersphincteric Resection, rectal cancer, pelvic autonomic nerve anal function