An interventional study of Extracorporeal anastomosis and Intracorporeal anastomosis in Colon Cancer, sponsored by University of Southern Denmark. Active, not recruiting at 1 site in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-08.
Sponsored by University of Southern Denmark · Not applicable, Interventional, and Treatment
In this study, the investigators will compare extracorporeal anastomosis (EA) with intracorporeal anastomosis (IA) in patients undergoing elective laparoscopic hemicolectomy for right colon cancer.
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.
1,432 studies on the registry are indexed under Colonic Neoplasms; 357 are open to participants now.
This study's enrollment of 104 is above the median of 90 across 1,034 interventional studies indexed under Colonic Neoplasms.
Browse Colonic Neoplasms studies →University of Southern Denmark is the lead sponsor of 327 studies on the registry; 45 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Laparoscopic right hemicolectomy with Extracorporeal anastomosis in patients with colon cancer.
Procedure: Extracorporeal 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. 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.
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.
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)
Time frame: 30 days
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.
Time frame: Up to 30 days
Time until bowel recovery
Measured in hours from end of surgery to first flatus and first bowel movement respectively
Time frame: Up to 30 days
Length of hospital stay
Measured in hours from end of surgery until the patient is discharged
Time frame: 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.
Time frame: Up to 30 days
Hernia rate
Based on CT scans 1 and 3 years post surgery
Time frame: 3 years
Plan to share: No
This study is active, not recruiting, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of Southern Denmark