Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy – a Randomized Control Trial.

Overview

Both extracorporeal and intracorporeal anastomosis in laparoscopic right hemicolectomy are renowned and performed worldwide. Many observational studies show conflicting results which method is better. This randomized control trial aimed to assess which technique is superior.

Full Title of Study: “Intracorporeal Anastomosis Accelerates Bowel Function in Comparison to Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy – a Randomized Control Trial.”

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Study Primary Completion Date: April 1, 2020

Interventions

• Procedure: Intracorporeal anastomosis
  • Anastomosis performed totally laparoscopically
• Procedure: Extracorporeal anastomosis
  • Anastomosis performed through a minilaparotomy

Arms, Groups and Cohorts

• Active Comparator: Extracorporeal anastomosis
• Experimental: Intracorporeal anastomosis

Clinical Trial Outcome Measures

Primary Measures

• Time to first stool
  • Time Frame: 5 days

Secondary Measures

• Time to first flatus
  • Time Frame: 5 days
• Complications
  • Time Frame: 30 day
• Length of surgery
  • Time Frame: 1 day
• Length of hospital stay
  • Time Frame: 30 day

Participating in This Clinical Trial

Inclusion Criteria

• malignant or benign neoplasm located in right side of the colon Exclusion Criteria:

• stage IV disease – conversion – inflammatory bowel diseases – corticosteroid intake – immunodeficiency – emergency surgery – neoadjuvant therapy – no technical possibility to perform either anastomosis

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

• Lead Sponsor
  • Jagiellonian University
• Provider of Information About this Clinical Study
  • Principal Investigator: Michał Pędziwiatr, Professor – Jagiellonian University