Robotic-assisted and Laparoscopic Right Colectomy Study - Intracorporeal vs. Extracorporeal Anastomoses

Completed

• Conditions: Benign Right Colon Disease; Malignant Right Colon Disease
• Interventions: Procedure: Right Colectomy with Intracorporeal Anastomosis; Procedure: Right Colectomy with Extracorporeal Anastomosis

• Registration Number: NCT03312569
• Lead Sponsor: Intuitive Surgical

Brief Summary

To compare intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies

Detailed Description

This is a prospective multicenter observational study to evaluate outcomes of intracorporeal and extracorporeal anastomoses for robotic-assisted and laparoscopic right colectomies.

Study Timeline

• Study First Submitted: 2017-10-12
• Study First Submitted QC: 2017-10-12
• Study First Posted: 2017-10-17
• Study Start: 2018-02-01
• Primary Completion: 2022-02-14
• Study Completion: 2023-07-24
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-11
• Last Update Posted: 2024-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

• Subject is 18 years or older
• Subject undergoing either laparoscopic or robotic-assisted right colectomy for benign or malignant right colon disease
• Subject undergoing intracorporeal or extracorporeal anastomosis proximal to mid-transverse colon

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Exclusion Criteria

• Subject is contraindicated for general anesthesia or surgery
• Emergent Case
• Subject has perforated, obstructing or locally invasive neoplasm (T4b)
• Subject with inflammatory bowel disease
• Subject with prior incisional hernia repair
• Planned right colectomy along with major concomitant procedures (e.g. hepatectomies, other intestinal resections).
• Metastatic disease with life expectancy of less than 1 year
• Pregnant or suspect pregnancy
• Subject is mentally handicapped or has a psychological disorder or severe systemic illness that would preclude compliance with study requirements or ability to provide informed consent
• Subject belonging to other vulnerable population, e.g, prisoner or ward of the state

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Intracorporeal Anastomosis	Right Colectomy with Intracorporeal Anastomosis	Participants will undergo either robotic-assisted or laparoscopic surgery with an intracorporeal anastomosis due to begin or malignant Right Colon Disease.
Extracorporeal Anastomosis	Right Colectomy with Extracorporeal Anastomosis	Participants will undergo either robotic-assisted or laparoscopic surgery with an extracorporeal anastomosis due to begin or malignant Right Colon Disease.

Primary Outcome Measures

Name	Time	Method
Incidence of incisional hernia at one year after index procedure.	1 year	The primary endpoint of the study is the incidence of incisional hernia for intracorporeal and extracorporeal anastomoses within one year after the right colectomy procedure. Incidence of incisional hernia either patient self-reported or clinical diagnosis will be assessed at one year after the right colectomy procedure.

Secondary Outcome Measures

Name	Time	Method
Time to first flatus after index procedure	up to 1 week after index procedure	The secondary endpoint of the study is time to first flatus for intracorporeal and extracorporeal anastomoses after the right colectomy procedure. Time to first flatus is defined as days from a right colectomy procedure to first occurrence of flatus during subject's post-operative recovery.

Trial Locations

Locations (4)

Washington University at St. Louis; 🇺🇸 Saint Louis, Missouri, United States

University of California; 🇺🇸 Irvine, California, United States

St. Joseph Mercy Hospital; 🇺🇸 Ann Arbor, Michigan, United States

Allegheny General Hospital; 🇺🇸 Pittsburgh, Pennsylvania, United States