Intracorporeal Vs Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy

NCT03990714 | Completed DMC

• 1 other identifier: HUTorrecardenas
• Study Type: interventional
• Target: 168
• Locations: 0 countries
• Sites: N/A

Brief Summary

Objective. The aim of this study was to evaluate short-term outcomes of performing intracorporeal versus extracorporeal anastomosis in laparoscopic right hemicolectomy for right colon neoplasm. Background. Despite advances in laparoscopic approach in colorectal surgery and the clear benefit of this approach over open surgery, the technical difficulty in performing intracorporeal anastomosis causes certain groups continue performing it extracorporeally in right colon surgery. Methods. This study was a prospective multicenter randomized trial with two parallel groups being done intracorporeal anastomosis (IA) or extracorporeal anastomosis (EA) in laparoscopic right hemicolectomy for right colon neoplasm, carried out between January 2016 and December 2018.

Conditions

Colorectal Surgery; Anastomotic Leak; Colectomy; Laparoscopy

Keywords

Right hemicolectomy; Intracorporeal anastomosis; Extracorporeal anastomosis; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• In patients with right colon cancer, laparoscopic right hemicolectomy with intracorporeal anastomosis presents less perioperative morbidity than extracorporeal anastomosis.

  To compare perioperative morbidity between laparoscopic right hemicolectomy with intracorporeal anastomosis versus extracorporeal anastomosis within 30 days after surgery.

  24 months

Secondary Outcomes (5)

• Surgical time

  4 hours

• VAS

  24 hour

• Dehiscence

  30 days

• Infection rate

  30 days

• Days of hospital stay

  180 days

Study Arms (2)

Intracorporeal anastomosis

EXPERIMENTAL

The specimen was preferentially extracted via a small Pfannenstiel-type incision with the protection of an Alexis Wound Protector (Applied Medical, Rancho Santa Margarita, California, USA). The incision for the extraction of the right colon is sutured in two layers by absorbable suture. The ileum was held by the assistant to prevent rotation of its mesentery. A stay suture was applied 10 cm proximal and distal to the stapled ends of the terminal ileum and colon, respectively, and then held by the assistant. An enterotomy and colotomy were made sharply at the antimesenteric corner of the staple lines. An isoperistaltic side-to-side anastomosis was fashioned with a 60-mm laparoscopic stapler. A 2-0 double-barbed suture was used to close the enterocolotomy, in two planes (the first submucosal, and the second sero-serous). The mesenteric defect and the mesocolon after the construction of either type of anastomosis were not closed. Drains were not used routinely.

Procedure: Right hemicolectomy

Extracorporeal anastomosis

EXPERIMENTAL

The mobilized colon was externalized preferentially via a transverse or midline incision with the protection of an Alexis Wound Protector (Applied Medical, Rancho Santa Margarita, California, USA). A stay suture was applied 10 cm proximal and distal to the stapled ends of the terminal ileum and colon. An enterotomy and colotomy were made sharply at the antimesenteric corner of the staple lines. An isoperistaltic side-to-side anastomosis was fashioned with a 60-mm laparoscopic stapler. A 2-0 double-barbed suture was used to close the enterocolotomy, in two planes (the first submucosal, and the second sero-serous). The mesenteric defect and the mesocolon after the construction of either type of anastomosis were not closed.The incision for the extraction of the right colon and the realization of the anastomosis is sutured in two layers by absorbable suture. Drains were not used routinely.

Procedure: Right hemicolectomy

Interventions

Right hemicolectomy PROCEDURE

It is the resection of the right colon by a tumor and the reconstruction by an ileocolic anastomosis: intracorporeal or extracorporeal

Extracorporeal anastomosis; Intracorporeal anastomosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients had to be 18 years of age or over, to be programmed for laparoscopic surgery for right colon neoplasm and provide a signed written consent form.

Sponsors & Collaborators

• Hospital Universitario Torrecárdenas: lead
• Sponsor- Investigator MD Ángel Reina Duarte. HUTorrecárdenas: collaborator
• Sponsor-Investigator BA Francisco Rubio Gil. HU Torrecárdenas: collaborator
• Sponsor-Investigator MD Elisabet Vidaña Márquez. HU Torrecárdenas: collaborator
• Sponsor-Investigator MD Juan Manuel García Torrecillas. HU Torrecárdenas: collaborator
• Sponsor-Investigator Rocío Torres Fernández. HU Torrecárdenas: collaborator
• Sponsor-Investigator MD Almudena Moreno Serrano. Hospital Inmaculada. Huercal-Overa: collaborator
• Sponsor-Investigator MD Pedro Moya Forcén. HU Torrecárdenas: collaborator
• Sponsor-Investigator MD Jorge Alejandro Benavides Buleje. HU Reina Sofía: collaborator

Related Publications (20)

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  PMID: 23250636 RESULT

MeSH Terms

Conditions

Anastomotic Leak

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Manuel Ferrer-Marquez

  Colorectal Surgeon

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Model Details: The IVEA-study is a prospective multicenter randomized trial with two parallel groups being done IA or EA in laparoscopic right hemicolectomy for right colon neoplasia.

Study Record Dates

• First Submitted: June 12, 2019
• First Posted: June 19, 2019
• Study Start: January 1, 2016
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share