Comparison of Intracorporeal and Extracorporeal Anastomoses for Minimally Invasive Right Colectomy

NCT03019016 | Completed

• 1 other identifier: ISI-dVRC-001
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Colonic Neoplasms; Crohn Disease

Outcome Measures

Primary Outcomes (1)

• Chart review on PeriOperative Information

  Number of complications observed intraoperatively through 30-days

  Intraoperative through 30-days follow-up

Secondary Outcomes (1)

• Chart review on Postoperative Information

  Postoperative through 6 month follow-up

Study Arms (4)

Robotic RC (IA)

Benign or malignant disease under going a right colectomy.

Procedure: Right Colectomy

Robotic RC (EA)

Patients with benign or malignant disease under going a right colectomy.

Procedure: Right Colectomy

Laparoscopic RC (IA)

Patients with benign or malignant disease under going a right colectomy.

Procedure: Right Colectomy

Laparoscopic RC (EA)

Patients with benign or malignant disease under going a right colectomy.

Procedure: Right Colectomy

Interventions

Right Colectomy PROCEDURE

Robotic-assisted or laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis either on or proximal to midtransverse colon.

Laparoscopic RC (EA); Laparoscopic RC (IA); Robotic RC (EA); Robotic RC (IA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intuitive Surgical: lead

MeSH Terms

Conditions

Colonic Neoplasms; Crohn Disease

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Inflammatory Bowel Diseases; Gastroenteritis

Study Officials

• Shilpa Mehendale

  Sr Director, Clinical Affairs, Intuitive Surgical, Inc.

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: January 12, 2017
• Study Start: August 1, 2016
• Primary Completion: September 1, 2017
• Study Completion: October 1, 2017
• Last Updated: October 26, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will share