Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Crohn Disease; Colonic Neoplasms
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 1000

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chart review on PeriOperative Information	Number of complications observed intraoperatively through 30-days	Intraoperative through 30-days follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chart review on Postoperative Information	Number of complications observed postoperatively through 6 month	Postoperative through 6 month follow-up

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: August 1, 2016
• Primary Completion (Actual): September 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: August 29, 2016
• First Submitted That Met QC Criteria: January 10, 2017
• First Posted (Estimate): January 12, 2017

Study Record Updates

• Last Update Posted (Actual): October 26, 2017
• Last Update Submitted That Met QC Criteria: October 24, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Gastroenteritis; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Colorectal Neoplasms; Inflammatory Bowel Diseases; Crohn Disease; Colonic Neoplasms
• Other Study ID Numbers: ISI-dVRC-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES