OBJECTIVE: The aim of the study is to demonstrate that the intracorporeal resection andanastomosis in left-sided colon cancer, sigma and upper rectum, is not inferior toextracoprporeal resection and anastomosis, in terms of anastomotic leakage.BACKGROUND: Due to the recent events of a pandemic respiratory disease secondary toinfection by SARS-CoV-2 virus or coronavirus 19 (COVID19), surgeons have been forced toadapt our surgical procedures in order to minimize exposure to the virus as much aspossible.Based on the recommendations in case of surgery in patients with highly contagious viraldiseases, the latest studies suggest minimally invasive accesses to minimize the risk ofcontagion. One of the proposed measures is the performance of intracorporeal anastomoses.Therefore, given the extensive experience of our center in minimally invasive surgery andstudies on the validation of intracorporeal anastomosis techniques in both laparoscopicsurgery of the right colon and rectum (TaTME), and the study of advantages that they canprovide to the patient, our intention is to apply it to surgery on the left colon, sigmaand upper rectum. Our hypothesis is that exteriorization of the colon through anaccessory incision increases the risk of tension at the mesocolon level, thus increasingthe risk of vascular deficit at the level of the staple area and it may increase the rateof anastomotic leakage. In this sense, studies that validate a standard technique ofintracorporeal anastomosis in left colon surgery and that demonstrate its benefit withrespect to extracorporeal anastomosis are lacking. We intend to describe a newintracorporeal anastomosis technique (ICA) that is feasible and safe for the patient andthat can be applied universally. Once the ICA technique is established, it will allow usto determine its non-inferiority compared to the standard technique performed up to nowwith extracorporeal anastomosis.METHODS: All consecutive patients with left-sided, sigma and upper rectum adenocarcinomawill be included into a prospective cohort and treated by laparoscopy with totallyintracorporeal resection and anastomosis. They will be compared with a retrospectivecohort of consecutive patients of identical characteristics treated by laparoscopy withextracorporeal resection and anastomosis, in the immediate chronological period.
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.
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)
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.
Hospital Universitario Parc Tauli de Sabadel
Sabadell, Barceelona, Spain
Investigator: Xavier Serra-Aracil, MD,PhD
Contact: 937 231 010
jserraa@tauli.cat
Xavier Serra-Aracil, MD,PhD
34-93-723-1010 - 21490
jserraa@tauli.cat
Xavier Serra-Aracil, MD,PhD, Principal Investigator
Corporacio Parc Tauli. Parc Tauli University Hospital