Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

Sponsor

Intuitive Surgical (Industry)

Overall Status

Completed

CT.gov ID

NCT03019016

Collaborator

(none)

1,000

Enrollment

Duration (Months)

Study Details

Study Description

Brief Summary

The primary objective of this study is to retrospectively compare the perioperative and short-term (discharge through 30 days) outcomes of intracorporeal and extracorporeal anastomosis in minimally invasive right colectomies for benign and malignant disease.

The secondary objective of this study is to retrospectively compare the rates of incisional hernia (up to 6 month post procedure) between intracorporeal and extracorporeal arms.

Condition or Disease	Intervention/Treatment	Phase
Colonic Neoplasms Crohn Disease	Procedure: Right Colectomy

Detailed Description

This is a multi-center, retrospective chart review study of all consecutive cases of right colectomy performed by participating surgeons at their respective institutions that meet all inclusion and exclusion criteria. All cases of right colectomy performed with intracorporeal or extracorporeal anastomoses or via laparoscopic or robotic platforms that meet the study inclusion and exclusion criteria, will be considered for inclusion. The chart review will be performed in a reverse chronological order starting at a minimum of 30 days prior to IRB approval of the study at the site until the number of robotic-assisted and laparoscopic cases to be included per surgeon has been met. Study initiation at the participating site will occur once a research agreement has been executed between Intuitive Surgical and the participating Institution/Investigator and IRB approval has been obtained.

It is anticipated that the retrospective chart review will span the period between January 1, 2010 through 30-days prior to IRB approval of the study in 2016. Baseline patient characteristics, perioperative and post-operative short term clinical and pathological outcomes, and incisional hernia data will be obtained from hospital records for a total of up to approximately 1000 robotic and laparoscopic cases, among the 4 subgroups: robotic-assisted right colectomy with intracorporeal anastomosis (RRCIA), robotic-assisted right colectomy with extracorporeal anastomosis (RRCEA), laparoscopic right colectomy with intracorporeal anastomosis (LRCIA) and laparoscopic right colectomy with extracorporeal anastomosis (RRCEA). Since the data will have been de-identified, and is archival in nature, there will be no active subject recruitment.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

A Multi-Center Retrospective Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

Study Start Date :

Aug 1, 2016

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Oct 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Robotic RC (IA) Benign or malignant disease under going a right colectomy.	Procedure: Right Colectomy Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
Robotic RC (EA) Patients with benign or malignant disease under going a right colectomy.	Procedure: Right Colectomy Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
Laparoscopic RC (IA) Patients with benign or malignant disease under going a right colectomy.	Procedure: Right Colectomy Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.
Laparoscopic RC (EA) Patients with benign or malignant disease under going a right colectomy.	Procedure: Right Colectomy Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.

Outcome Measures

Primary Outcome Measures

Chart review on PeriOperative Information [Intraoperative through 30-days follow-up]
Number of complications observed intraoperatively through 30-days

Secondary Outcome Measures

Chart review on Postoperative Information [Postoperative through 6 month follow-up]
Number of complications observed postoperatively through 6 month

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Age ≥ 18 years
Patients with benign or malignant right colon disease
Patients who have undergone robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to mid-transverse colon

Exclusion Criteria:

Patients with perforated, obstructing or locally invasive neoplasm (T4b)
Emergency procedures
Patients undergoing right colectomy as a secondary procedure
Patients undergoing radiation therapy for malignant neoplasia before and after procedure

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Intuitive Surgical

Investigators

Study Director: Shilpa Mehendale, Sr Director, Clinical Affairs, Intuitive Surgical, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Intuitive Surgical

ClinicalTrials.gov Identifier:

NCT03019016

Other Study ID Numbers:

ISI-dVRC-001

First Posted:

Jan 12, 2017

Last Update Posted:

Oct 26, 2017

Last Verified:

Oct 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Additional relevant MeSH terms:

Colonic Neoplasms

Crohn Disease

Study Results

No Results Posted as of Oct 26, 2017