Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer
- Conditions
- Colon Cancer
- Interventions
- Procedure: Extracorporeal anastomosisProcedure: Intracorporeal anastomosis
- Registration Number
- NCT05039762
- Lead Sponsor
- University of Southern Denmark
- 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.
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 104
- 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.
- Pregnancy
- Mental incompetence
- Acute right hemicolectomy before the intended elective surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Extracorporeal anastomosis Extracorporeal anastomosis Laparoscopic right hemicolectomy with Extracorporeal anastomosis in patients with colon cancer. Intracorporeal anastomosis Intracorporeal anastomosis Laparoscopic right hemicolectomy with Intracorporeal anastomosis in patients with colon cancer.
- Primary Outcome Measures
Name Time Method Overall complication rate 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)
- Secondary Outcome Measures
Name Time Method Length of hospital stay Up to 30 days Measured in hours from end of surgery until the patient is discharged
Time until bowel recovery Up to 30 days Measured in hours from end of surgery to first flatus and first bowel movement respectively
Surgical stress response 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.Postoperative pain 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.
Hernia rate 3 years Based on CT scans 1 and 3 years post surgery
Trial Locations
- Locations (1)
Odense University Hospital, Svendborg
🇩🇰Svendborg, Denmark