Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer

NCT05039762 | Active Not Recruiting

• 1 other identifier: ICEA-051-2016-NQ
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

In this study, the investigators will compare extracorporeal anastomosis (EA) with intracorporeal anastomosis (IA) in patients undergoing elective laparoscopic hemicolectomy for right colon cancer.

Conditions

Colon Cancer

Keywords

Laparoscopic right hemicolectomy; Intracorporeal anastomosis; Extracorporeal anastomosis

Outcome Measures

Primary Outcomes (1)

• Overall complication rate

  According to the Comprehensive Complication Index (CCI) based on the Clavien Dindo classification of postsurgical complications. CCI is a continuous scale from 0-100 (0 equals no complications, 100 equals death)

  30 days

Secondary Outcomes (5)

• Surgical stress response

  Up to 30 days

• Time until bowel recovery

  Up to 30 days

• Length of hospital stay

  Up to 30 days

• Postoperative pain

  Up to 30 days

• Hernia rate

  3 years

Study Arms (2)

Extracorporeal anastomosis

ACTIVE COMPARATOR

Laparoscopic right hemicolectomy with Extracorporeal anastomosis in patients with colon cancer.

Procedure: Extracorporeal anastomosis

Intracorporeal anastomosis

EXPERIMENTAL

Laparoscopic right hemicolectomy with Intracorporeal anastomosis in patients with colon cancer.

Procedure: Intracorporeal anastomosis

Interventions

Extracorporeal anastomosis PROCEDURE

Laparoscopic right hemicolectomy will be carried out. The dissection is performed laparoscopically. When the right hemicolon is sufficiently mobilized and the vessels (ileocolic pedicle, right colic pedicle and the right branch of the middle colic pedicle) are ligated, a horizontal incision in the upper right quadrant is made. Through this incision the right hemicolon is extracted, the small bowel and the transverse colon are divided using staplers. The side-to-side ileocolic anastomosis is then handsewn.

Extracorporeal anastomosis

Intracorporeal anastomosis PROCEDURE

Laparoscopic right hemicolectomy will be carried out. The dissection is performed laparoscopically. The right hemicolon is mobilized and the vessels (ileocolic pedicle, right colic pedicle and the right branch of the middle colic pedicle) are ligated. The small bowel and the transverse colon are then divided using laparoscopic staplers. The side-to-side ileocolic anastomosis is formed by creating a small opening in the small bowel and the transverse colon, through which the laparoscopic stapler is used to join the bowel ends. The remaining opening is sutured laparoscopically. The specimen is retrieved through a Pfannenstiel incision.

Intracorporeal anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with right colon cancer
• Eligible for elective laparoscopic right hemicolectomy with primary anastomosis.
• Eastern Cooperative Oncology Group (ECOG) performance status 0-2
• CT staged T1-T3M0 tumour.

You may not qualify if:

• Pregnancy
• Mental incompetence
• Acute right hemicolectomy before the intended elective surgery

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Odense University Hospital, Svendborg

Svendborg, 5700, Denmark

Location

Related Publications (19)

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  PMID: 40198370 DERIVED

MeSH Terms

Conditions

Colonic Neoplasms

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

Study Officials

• Benedicte Schelde-Olesen, MD

  Odense University Hospital, Svendborg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Prospective, single center, non-randomized, non-blinded

Study Record Dates

• First Submitted: November 11, 2020
• First Posted: September 10, 2021
• Study Start: September 2, 2020
• Primary Completion: April 30, 2022
• Study Completion: April 30, 2025
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)