Intracorporeal Anastomosis in Laparoscopic Left Colectomy. Cohort Comparative Study

Colon Cancer Clinical Trial

— RIAL-COLECTOMY  

Official title:

RESECTION AND INTRACORPOREAL ANASTOMOSIS IN LAPAROSCOPIC LEFT COLECTOMY AS AN ADAPTATION TO THE PANDEMIC CAUSED BY SARS-CoV-2 (COVID19). A COMPARATIVE COHORT STUDY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04456933
• Other study ID #: HEMI-E-INTRACORPOREA-2020
• Status: Recruiting
• Start date: June 29, 2020
• Est. completion date: February 28, 2022

Study information

• Verified date: November 2021
• Source: Corporacion Parc Tauli
• Contact: Xavier Serra-Aracil, MD,PhD
• Phone: 34-93-723-1010
• Email: jserraa[@]tauli.cat
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

HYPOTHESIS Resection of the left colon / sigmoid with intracorporeal colorectal TT anastomosis is safe and not inferior to that performed extracorporeally. With the benefits of reduced intraoperative dissection, traction on the mesenteries, reduced vascular compromise of the anastomosis, a smaller incision size and being able to choose its location.

Main Aim:

The objective of this study is to demonstrate that colorectal mechanical end-to-end intracorporeal anastomosis is not inferior to extracorporeal approach in terms of anastomotic dehiscence.

Secondary Aims:

• To demonstrate the reproducibility of the colorectal mechanical end-to-end intracorporeal anastomosis technique in terms of reconversion, anastomotic dehiscence, organo-cavitary infection, and other postoperative complications.

• To determine the benefits that the IC anastomosis technique can bring to patients with obesity.

• To determine the benefits that the IC anastomosis technique can provide in terms of postoperative complications, hospital stay, and size of the accessory incision.

• To determine the benefit of the application of indocyanine green to determine the point of resection and anastomosis.

STUDY DESIGN

Comparative, single-center, controlled non-inferiority cohort study of resection and mechanical end-to-end intracorporeal anastomosis in left colon, sigmoid, and upper rectum surgery (prospective cohort) versus the standard technique of extracorporeal laparoscopic surgery (retrospective cohort).

SUBJECTS OF THE STUDY

In group 1 or control (retrospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum who meet the inclusion criteria Operated on surgically by our unit, collected in our database, by laparoscopic oncological surgery applying the conventional extracorporeal anastomosis technique.

In group 2 or case (prospective cohort): patients diagnosed with adenocarcinoma of the left colon, sigmoid or upper rectum, that meet the inclusion criteria, with an oncological surgical indication with a laparoscopic approach since July 2020, to which the resection and intracoporeal anastomosis technique will be applied.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 148
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Left Colonic Adenocarcinoma. Location of the tumor in the left colon, sigma or high rectum (with the anastomosis performed above the peritoneal reflection). Non-metastatic stage. Scheduled oncological surgery with curative intention operated on with laparoscopic surgery with resection technique and intracorporeal anastomosis. Over 18 years

Exclusion Criteria:

• Other tumor locations. Non-adenocarcinoma tumors. Synchronous tumors. T4 tumor stage and stage IV of TNM classification. ASA IV (American Society of Anesthesiologists). Non-optimal nutritional study (preoperative albumin =3.4 g / dl). Do not sign informed consent. Pregnant patients. Diagnosis of another type of neoplasm with active disease. Liver cirrhosis, Chronic kidney failure on dialysis treatment, patients with stent bridge to elective surgery.

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

Intervention

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®
• 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)

Locations

Country	Name	City	State
Spain	Hospital Universitario Parc Tauli de Sabadel	Sabadell	Barceelona

Sponsors (9)

Lead Sponsor	Collaborator
Corporacion Parc Tauli	Albert García Nalda, Anna Pallisera-Lloveras, Anna Serracant-Barrera, Irene Gómez Torres, Laura Mora López, Mercedes Muñoz, Oriol Pino-Pérez, Sheila Serra-Pla

Country where clinical trial is conducted

Spain, 

References & Publications (2)

Akamatsu H, Omori T, Oyama T, Tori M, Ueshima S, Nakahara M, Abe T, Nishida T. Totally laparoscopic sigmoid colectomy: a simple and safe technique for intracorporeal anastomosis. Surg Endosc. 2009 Nov;23(11):2605-9. doi: 10.1007/s00464-009-0406-6. Epub 2009 Mar 6. — View Citation

Serra-Aracil X, Mora-López L, Casalots A, Pericay C, Guerrero R, Navarro-Soto S. Hybrid NOTES: TEO for transanal total mesorectal excision: intracorporeal resection and anastomosis. Surg Endosc. 2016 Jan;30(1):346-54. doi: 10.1007/s00464-015-4170-5. Epub 2015 Mar 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of anastomotic leak (AL)	Percentage of anastomic leak (defined in accordance with Peel et al.).	30 days
Secondary	Rate of global morbidity	Dindo-Clavien Classification	30 days
Secondary	Rate of Surgical site infection	SSI in accordance with the Center for Disease Control (CDC) National	30 days
Secondary	Rate of Re-interventions	Percentage of re-interventions due to surgical complications	30 days