Intra-corporeal vs Extra-corporeal Anastomosis in Laparoscopically Assisted Right Hemicolectomy

Not Applicable

Completed

• Conditions: Pain
• Interventions: Procedure: Intracorporeal anastomosis.; Procedure: Extracorporeal anastomosis; Device: Proximate Linear Cutter; Device: Echelon Endopatch

• Registration Number: NCT02667860
• Lead Sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Brief Summary

The creation of an intracorporeal anastomosis during right hemicolectomy is regarded as superior than the extracorporeal anastomosis in terms of recovery of peristalsis, aesthetic results, analgesia requirements and length of hospital stay. The objective of this study is to compare the postoperative results of intracorporeal versus extracorporeal anastomosis in patients undergoing laparoscopic right hemicolectomy.

Detailed Description

Laparoscopic surgery has entailed a great technical revolution in colorectal surgery, providing a better and quicker return to normal functions of the patients, associating a lower morbidity and better aesthetic results compared with traditional open surgery. This study wants to find the difference between intracorporeal and extracorporeal anastomosis.

The creation of an intracorporeal anastomosis in right hemicolectomy seems superior to extracorporeal anastomosis in terms of recovery of the normal bowel function, wound size, aesthetic results and analgesia requirements. This will entail a shorter hospital stay. Several studies have demonstrated this but all of them are retrospective non randomised.

In terms of postoperative pain, the most accepted theory is that it depends on the traction of the porto-mesenteric axis. When the intracorporeal anastomosis is performed there is no traction of this mesenteric axis while in the extracorporeal anastomosis this traction is more important in obese patients.

This traction of the mesentery, as well as being one of the main factors related with postoperative pain, is responsible of the postoperative adynamic ileus, that should have a higher incidence when the manipulation is higher.

In the patients undergoing an intracorporeal anastomosis, the assistance incision will be a suprapubic Pfannenstiel. In the patients undergoing an extracorporeal anastomosis the assistance incision will be a transverse in the right upper quadrant. It is well known that the Pfannenstiel incision has a lower incidence of superficial surgical wound infection, a lower rate of incisional hernia, a lower need of analgesics, and better aesthetic results, when compared with the incision in the right upper quadrant.

All this factors should entail a lower hospital stay in patients undergoing an intracorporeal anastomosis.

Study Timeline

• Study Start: 2015-05-20
• Study First Submitted: 2016-01-13
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Primary Completion: 2018-06-21
• Study Completion: 2018-07-21
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-11
• Last Update Posted: 2019-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

Inclusion Criteria

• Surgical procedure with curative purpose.
• American Society of Anaesthesiologists Physical Status (ASA) I, II and III.
• Elective surgery.
• Informed consent.

Exclusion Criteria

• Denial of informed consent.
• Advanced neoplasia.
• Urgent surgery.
• ASA IV.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Extracorporeal anastomosis	Proximate Linear Cutter	A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Rel Stapler
Intracorporeal anastomosis	Intracorporeal anastomosis.	Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision.
Intracorporeal anastomosis	Echelon Endopatch	Iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Echelon Endopatch and closure of the defect with running suture or another firing of Echelon Endopatch. The surgical specimen will be retrieved through a Pfannenstiel incision.
Extracorporeal anastomosis	Extracorporeal anastomosis	A transverse incision in the right upper quadrant will be performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Rel Stapler

Primary Outcome Measures

Name	Time	Method
Length of stay	1 month	is identified when the patient has tolerated diet and has had bowel movements and is discharged from the hospital

Secondary Outcome Measures

Name	Time	Method
Aesthetic result	1 month after discharge	Questionnaire
Size of the surgical wound	1 month	we measure the wound in cm
Return to normal peristalsis	1 week	Physiological parameter
Rate of Surgical Site Infection	1 month	clinical wound infection or positive culture
Rate of Incisional Hernia	1 year after discharge	Physical exploration and CT scan (performed during the follow up)
Postoperative pain	1 month after discharge	Questionnaire

Trial Locations

Locations (1)

Hospital de la Santa Creu i Sant Pau; 🇪🇸 Barcelona, Spain