Robotic-assisted Versus Laparoscopic Sigmoid Resection

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

• Status: Completed
• Conditions: Sigmoid Diseases
• Intervention / Treatment: Procedure: Sigmoid Resection

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

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85258
      • HonorHealth / Colon & Rectal Clinic of Scottsdale
  • Florida
    • Miami, Florida, United States, 33136
      • Jackson South Community Hospital
    • Tampa, Florida, United States
      • St. Joseph's Hospital
  • Illinois
    • New Lenox, Illinois, United States
      • Progressive Surgical Associates/Silver Cross Hospital
  • New York
    • Mt. Kisco, New York, United States, 10549
      • Northern Weschester Hospital
  • Pennsylvania
    • Phildelphia, Pennsylvania, United States
      • Aria Health

Participation Criteria

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

How is the study designed?

Number of groups / cohorts

2

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	Procedure: Sigmoid Resection
Laparoscopic sigmoid resection; Patient that have undergone laparoscopic sigmoid resection for benign or malignant disease between 2010 and 2015	Procedure: Sigmoid Resection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of complications observed intraoperatively through 30-days	Number of complications observed intraoperatively through 30-days	Intraoperative through 30-days follow-up

Collaborators and Investigators

• Sponsor: Intuitive Surgical

Study record dates

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: Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Sigmoid Diseases
• Other Study ID Numbers: ISI-dVSR-001