Robotic-assisted Versus Laparoscopic Sigmoid Resection

NCT ID: NCT02636673

Last Updated: 2016-08-30

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

COMPLETED

Total Enrollment

518 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-30

Study Completion Date

2016-08-31

Brief Summary

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Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic sigmoid resection for both benign and malignant disease

Detailed Description

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The goal is to establish safety and effectiveness of robotic-assisted surgery in sigmoid resection for both benign and malignant disease by evaluation of short-term clinical outcomes through 30 days post index procedure.

Conditions

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Sigmoid Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Robotic-assisted sigmoid resection

Patient that have undergone robotic-assisted sigmoid resection for benign or malignant disease between 2010 and 2015

Sigmoid Resection

Intervention Type PROCEDURE

Laparoscopic sigmoid resection

Patient that have undergone laparoscopic sigmoid resection for benign or malignant disease between 2010 and 2015

Sigmoid Resection

Intervention Type PROCEDURE

Interventions

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Sigmoid Resection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* All patients that have undergone sigmoid resection for benign or malignant disease

Exclusion Criteria

* Emergency Procedures
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Intuitive Surgical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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HonorHealth / Colon & Rectal Clinic of Scottsdale

Scottsdale, Arizona, United States

Site Status

Jackson South Community Hospital

Miami, Florida, United States

Site Status

St. Joseph's Hospital

Tampa, Florida, United States

Site Status

Progressive Surgical Associates/Silver Cross Hospital

New Lenox, Illinois, United States

Site Status

Northern Weschester Hospital

Mount Kisco, New York, United States

Site Status

Aria Health

Phildelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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ISI-dVSR-001

Identifier Type: -

Identifier Source: org_study_id

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