Clinical trial NCT05039762: Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer
Official title: Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer - A Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Colon Cancer
Keywords: Laparoscopic right hemicolectomy
Intracorporeal anastomosis
Extracorporeal anastomosis
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Prospective, single center, non-randomized, non-blinded
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Overall complication rate
timeFrame: 30 days
Secondary outcomes:
measure: Surgical stress response
timeFrame: Up to 30 days
measure: Time until bowel recovery
timeFrame: Up to 30 days
measure: Length of hospital stay
timeFrame: Up to 30 days
measure: Postoperative pain
timeFrame: Up to 30 days
measure: Hernia rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: Odense University Hospital, Svendborg
Study officials:
affiliation: Odense University Hospital, Svendborg
name: Benedicte Schelde-Olesen, MD
role: PRINCIPAL_INVESTIGATOR
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