- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02636673
Robotic-assisted Versus Laparoscopic Sigmoid Resection
August 29, 2016 updated by: Intuitive Surgical
Robotic-assisted Versus Laparoscopic Sigmoid Resection: a Retrospective Chart Review of Benign and Malignant Sigmoid Disease
Retrospective multi-center comparative chart review of robotic-assisted versus laparoscopic sigmoid resection for both benign and malignant disease
Study Overview
Detailed Description
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.
Study Type
Observational
Enrollment (Actual)
518
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85258
- HonorHealth / Colon & Rectal Clinic of Scottsdale
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Florida
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Miami, Florida, United States, 33136
- Jackson South Community Hospital
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Tampa, Florida, United States
- St. Joseph's Hospital
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Illinois
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New Lenox, Illinois, United States
- Progressive Surgical Associates/Silver Cross Hospital
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New York
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Mt. Kisco, New York, United States, 10549
- Northern Weschester Hospital
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Pennsylvania
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Phildelphia, Pennsylvania, United States
- Aria Health
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
All subjects that have undergone robotic-assisted or laparoscopic sigmoid resection for benign and malignant disease will be considered for inclusion except those that had emergency procedures.
Description
Inclusion Criteria:
- All patients that have undergone sigmoid resection for benign or malignant disease
Exclusion Criteria:
- Emergency Procedures
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Robotic-assisted sigmoid resection
Patient that have undergone robotic-assisted sigmoid resection for benign or malignant disease between 2010 and 2015
|
|
Laparoscopic sigmoid resection
Patient that have undergone laparoscopic sigmoid resection for benign or malignant disease between 2010 and 2015
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of complications observed intraoperatively through 30-days
Time Frame: Intraoperative through 30-days follow-up
|
Number of complications observed intraoperatively through 30-days
|
Intraoperative through 30-days follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2015
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
December 7, 2015
First Submitted That Met QC Criteria
December 17, 2015
First Posted (Estimate)
December 22, 2015
Study Record Updates
Last Update Posted (Estimate)
August 30, 2016
Last Update Submitted That Met QC Criteria
August 29, 2016
Last Verified
August 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ISI-dVSR-001
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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-
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