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

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

Detailed Description
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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.

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

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: Extracorporeal anastomosis
* Procedure: Intracorporeal anastomosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Prospective, single center, non-randomized, non-blinded
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Extracorporeal anastomosis<br>Laparoscopic right hemicolectomy with Extracorporeal anastomosis in patients with colon cancer. | Procedure: Extracorporeal anastomosis<br>* 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.<br>|
| Experimental: Intracorporeal anastomosis<br>Laparoscopic right hemicolectomy with Intracorporeal anastomosis in patients with colon cancer. | Procedure: Intracorporeal anastomosis<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical stress response | 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 | Measured in hours from end of surgery to first flatus and first bowel movement respectively | Up to 30 days | 
| Length of hospital stay | Measured in hours from end of surgery until the patient is discharged | Up to 30 days | 
| Postoperative pain | 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 | Based on CT scans 1 and 3 years post surgery | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic right hemicolectomy, Intracorporeal anastomosis, Extracorporeal anastomosis