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

NCT ID: NCT03597126

Last Updated: 2021-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2022-12-01

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.

Detailed Description

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Conditions

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Rectal Cancer

Keywords

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Robotic Intersphincteric Resection rectal cancer pelvic autonomic nerve anal function

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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robot-assisted ISR

Patients with low rectal cancer undergo intersphincteric resection assisted by Robotic

Group Type ACTIVE_COMPARATOR

Robot-assisted surgery

Intervention Type DEVICE

robot-assisted intersphincteric resection for low location rectal cancer(T=1\&2)

laparoscopic ISR

Patients with low rectal cancer undergo laparosocopic intersphincteric resection

Group Type ACTIVE_COMPARATOR

Laparoscopic surgery

Intervention Type DEVICE

laparoscopic intersphincteric resection for low location rectal cancer(T=1\&2)

Interventions

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Robot-assisted surgery

robot-assisted intersphincteric resection for low location rectal cancer(T=1\&2)

Intervention Type DEVICE

Laparoscopic surgery

laparoscopic intersphincteric resection for low location rectal cancer(T=1\&2)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Southwest Hospital, China

OTHER

Sponsor Role lead

Responsible Party

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Li Chuan

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Southwest Hospital

Chongqing, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Tang Bo, M.D

Role: CONTACT

Phone: +86 13883902288

Email: [email protected]

Li Chuan, M.D

Role: CONTACT

Phone: +86-18323479228

Email: [email protected]

Facility Contacts

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Yu Yupeiwu, M.D/Ph.D

Role: primary

Other Identifiers

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RoboticISR

Identifier Type: -

Identifier Source: org_study_id