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

December 1, 2022 updated by: Benedicte Schelde-Olesen, University of Southern Denmark

Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer - A Prospective Cohort Study

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

At Odense University Hospital, Svendborg, current standard treatment for right colon cancer is laparoscopic hemicolectomy with extracorporeal anastomosis (EA).

To reduce the risk of adverse events, such as fascial dehiscence and later development of incisional hernia, right hemicolectomy with intracorporeal anastomosis has been introduced.

When performing a laparoscopic right hemicolectomy the dissection is carried out intracorporeally and the transection and anastomosis is made extracorporeally (EA technique). For IA technique the cancer bearing segment is resected and the bowel ends joined intracorporeally with laparoscopic technique, and the specimen is then retrieved through a Pfannenstiel incision.

Previous series have shown shorter hospital stay as well as shorter time to bowel recovery in patients treated with IA compared to EA, without increasing the risk of severe complications or compromising the oncological outcome.

The aim of this study is to investigate whether IA in patients undergoing right hemicolectomy reduces the overall complication rate compared to EA evaluated by Comprehensive Complication Index (CCI) .

51 patients will be enrolled in each group.

Study Type

Interventional

Enrollment (Actual)

104

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Svendborg, Denmark, 5700
        • Odense University Hospital, Svendborg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Extracorporeal anastomosis
Laparoscopic right hemicolectomy with Extracorporeal anastomosis in patients with colon cancer.
Procedure: Extracorporeal anastomosis
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.
Experimental: Intracorporeal anastomosis
Laparoscopic right hemicolectomy with Intracorporeal anastomosis in patients with colon cancer.
Procedure: Intracorporeal anastomosis
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall complication rate
Time Frame: 30 days

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical stress response
Time Frame: Up to 30 days

Evaluated by C-reactive protein (CRP), leucocytes and National Early Warning Score (NEWS).

NEWS is an aggregate scoring system, based on physiological measurements, designed to help detect acute illness. Minimum score of 0 indicates normal measurements. The score increases with further deviation from the norm, with a maximum score of 20.
Up to 30 days
Time until bowel recovery
Time Frame: Up to 30 days
Measured in hours from end of surgery to first flatus and first bowel movement respectively
Up to 30 days
Length of hospital stay
Time Frame: Up to 30 days
Measured in hours from end of surgery until the patient is discharged
Up to 30 days
Postoperative pain
Time Frame: Up to 30 days
Registered daily using Visual analogue scale (VAS) for pain. The scale ranging from 0-10, 0 being no pain, 10 being worst pain imaginable.
Up to 30 days
Hernia rate
Time Frame: 3 years
Based on CT scans 1 and 3 years post surgery
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • Principal Investigator: Benedicte Schelde-Olesen, MD, Odense University Hospital, Svendborg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2020

Primary Completion (Actual)

April 30, 2022

Study Completion (Anticipated)

April 30, 2025

Study Registration Dates

First Submitted

November 11, 2020

First Submitted That Met QC Criteria

September 5, 2021

First Posted (Actual)

September 10, 2021

Study Record Updates

Last Update Posted (Actual)

December 2, 2022

Last Update Submitted That Met QC Criteria

December 1, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICEA-051-2016-NQ

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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