Robotic-assisted Versus Laparoscopic Sigmoid Resection

Sigmoid Diseases Clinical Trial

Official title:

Robotic-assisted Versus Laparoscopic Sigmoid Resection: a Retrospective Chart Review of Benign and Malignant Sigmoid Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02636673
• Other study ID #: ISI-dVSR-001
• Status: Completed
• Phase: N/A
• First received: December 7, 2015
• Last updated: August 29, 2016
• Start date: November 2015
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: Intuitive Surgical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 518
• Est. completion date: August 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Emergency Procedures

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Sigmoid Diseases

Intervention

Procedure:
• Sigmoid Resection

Locations

Country	Name	City	State
United States	Jackson South Community Hospital	Miami	Florida
United States	Northern Weschester Hospital	Mt. Kisco	New York
United States	Progressive Surgical Associates/Silver Cross Hospital	New Lenox	Illinois
United States	Aria Health	Phildelphia	Pennsylvania
United States	HonorHealth / Colon & Rectal Clinic of Scottsdale	Scottsdale	Arizona
United States	St. Joseph's Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Intuitive Surgical

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of complications observed intraoperatively through 30-days	Number of complications observed intraoperatively through 30-days	Intraoperative through 30-days follow-up	Yes