Intracorporeal Anastomosis in Laparoscopic Left Colectomy. Cohort Comparative Study

Summary

OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection and anastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior to extracoprporeal resection and anastomosis, in terms of anastomotic leakage.

BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary to infection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced to adapt our surgical procedures in order to minimize exposure to the virus as much as possible.

Based on the recommendations in case of surgery in patients with highly contagious viral diseases, the latest studies suggest minimally invasive accesses to minimize the risk of contagion. One of the proposed measures is the performance of intracorporeal anastomoses. Therefore, given the extensive experience of our center in minimally invasive surgery and studies on the validation of intracorporeal anastomosis techniques in both laparoscopic surgery of the right colon and rectum (TaTME), and the study of advantages that they can provide to the patient, our intention is to apply it to surgery on the left colon, sigma and upper rectum. Our hypothesis is that exteriorization of the colon through an accessory incision increases the risk of tension at the mesocolon level, thus increasing the risk of vascular deficit at the level of the staple area and it may increase the rate of anastomotic leakage. In this sense, studies that validate a standard technique of intracorporeal anastomosis in left colon surgery and that demonstrate its benefit with respect to extracorporeal anastomosis are lacking. We intend to describe a new intracorporeal anastomosis technique (ICA) that is feasible and safe for the patient and that can be applied universally. Once the ICA technique is established, it will allow us to determine its non-inferiority compared to the standard technique performed up to now with extracorporeal anastomosis.

METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinoma will be included into a prospective cohort and treated by laparoscopy with totally intracorporeal resection and anastomosis. They will be compared with a retrospective cohort of consecutive patients of identical characteristics treated by laparoscopy with extracorporeal resection and anastomosis, in the immediate chronological period.

Conditions

• Colon Cancer

Interventions

PROCEDURE

Extracorporeal left hemicolectomy anastomosis

Standard surgical technique protocolized in the unit for laparoscopic surgery of the left colon, sigma and high rectum for the last 10 years. After sectioning the distal colon using a mechanical stapler (60mm blue load), a pfannestiel-type suprapubic accessory incision is made, with externalization of the tumor under wound protection with a ringed retraction device. Both the resection of the left mesocolon or mesosigma, and the placement of the head of the circular stapler are performed extracorporeally by proximal section of the colon with a pursetring® self-suturing device, removal of the piece, placement of the head, and reconnection of the pneumoperitoneum for colorectal anastomosis with Circular Stapler Curved B. Braun®

PROCEDURE

Intracorporeal left hemicolectomy anastomosis

o Intracorporeal resection of the left mesocolon The mesocolon resection will be performed totally intracorporeally to its proximal end. The distal colon section will be performed using a mechanical stapler (blue charge 60mm) o Preparation of Intracorporeal Anastomosis The anastomosis will be performed in a mechanical end-to-end manner using a Circular Stapler Curved B. Braun®. The Insertion of the stapler head into the proximal colon will be placed intracorporeally with an incision distal to the staple section. Once the head has been exteriorized at the terminal end of the proximal colon, a circular purse-type suture with prolene 2.0 will be made. Once the mechanical colorectal anastomosis is performed, 4-6 stitches of anastomotic reinforcement with silk 2.0 will be placed. The extraction of the piece will be carried out with endobag protection and with an accessory incision (pfannestiel or other location depending on the patient)

Sponsors & Collaborators

• Irene Gómez Torres

  collaborator UNKNOWN

• Laura Mora López

  collaborator UNKNOWN

• Anna Pallisera-Lloveras

  collaborator UNKNOWN

• Sheila Serra-Pla

  collaborator UNKNOWN

• Albert García Nalda

  collaborator UNKNOWN

• Anna Serracant-Barrera

  collaborator UNKNOWN

• Mercedes Muñoz

  collaborator UNKNOWN

• Oriol Pino-Pérez

  collaborator UNKNOWN

• Corporacion Parc Tauli

  lead OTHER

Principal Investigators

• Xavier Serra-Aracil, MD,PhD · Corporacio Parc Tauli. Parc Tauli University Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-06-29

Primary Completion

2021-12-31

Completion

2022-02-28

Countries

• Spain

Study Locations