NCT02636673

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
518

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2015

Shorter than P25 for all trials

Geographic Reach
1 country

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

December 22, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

8 months

First QC Date

December 7, 2015

Last Update Submit

August 29, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • Number of complications observed intraoperatively through 30-days

    Number of complications observed intraoperatively through 30-days

    Intraoperative through 30-days follow-up

Study Arms (2)

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

Interventions

Laparoscopic sigmoid resectionRobotic-assisted sigmoid resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Emergency Procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

HonorHealth / Colon & Rectal Clinic of Scottsdale

Scottsdale, Arizona, 85258, United States

Location

Jackson South Community Hospital

Miami, Florida, 33136, United States

Location

St. Joseph's Hospital

Tampa, Florida, United States

Location

Progressive Surgical Associates/Silver Cross Hospital

New Lenox, Illinois, United States

Location

Northern Weschester Hospital

Mount Kisco, New York, 10549, United States

Location

Aria Health

Phildelphia, Pennsylvania, United States

Location

MeSH Terms

Conditions

Sigmoid Diseases

Condition Hierarchy (Ancestors)

Colonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 7, 2015

First Posted

December 22, 2015

Study Start

November 1, 2015

Primary Completion

July 1, 2016

Study Completion

August 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations