Neoplasms

Digestive System Diseases

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Gastrointestinal Diseases

Colonic Diseases

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Cola

Experimental: 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 is retrieved through a Pfannenstiel incision.

A transverse incision in the right upper quadrant is performed. An iso or anti-peristaltic side-to-side ileo-colonic anastomosis with Proximate Linear Cutter device and Proximate Rel Stapler

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.

Device:

Use of an Echelon Endopatch Powered Device to perform an ileocolonic side-to-side anastomosis.

Intracorporeal 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 Stapler.

Device:

Use of a Proximate Linear Cutter device to perform a side-to-side ileo-colonic anastomosis.Use of a Proximate stapler to the closure of the defect associated with the creation of the side-to-side ileo-colonic anastomosis.

Extracorporeal anastomosis

Anna Sánchez López

Anna Sánchez López, Faculty

Advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA) compared to extracorporeal anastomosis (EA) are widely studied. Nowadays we can conclude, with a high level of scientific evidence, that there are a number of short-term clinical advantages of laparoscopic right colectomy with intracorporeal anastomosis (IA).

However, there is currently no randomized studies describing long-term clinical and oncological outcomes.

Background:

Little evidence has been published demonstrating the advantages of IA versus EA.

Recent publications show the superiority of IA in terms of early functional digestive recovery, a shorter surgical incision, a lower need for analgesia, lower blood loss, and lower postoperative Clavien-Dindo grade. These results are similar to other further published studies, including multicenter randomized clinical trials and meta-analyses.

Methods:

This is a a long-term clinical follow-up study of 140 patients included preaviously in the single-blind single-center randomized prospective clinical trial conducted at the Hospital de la Santa Creu i Sant Pau (HSCSP) between 2015-2018; in which 30-day clinical outcomes after laparoscopic right colectomy for colon cancer with IA vs EA anastomosis were compared.

In this new trial, prospective clinical follow-up of the included 140 patients, randomized in two groups IA and EA, will be carried out, with a minimum time of 3 years.

The main objective of the study will be:

-Comparing long-term oncological outcomes of IA vs. EA anastomosis in laparoscopic right colectomy for malignant neoplasm.

The secondary objectives will be:

* Analyzing the appearance of abdominal wall hernias and episodes of occlusion.
* Describing the direct costs of both techniques retrospectively, through the financial records of the HSCSP institution.

The main hypothesis will be:

-IA is not inferior compared to EA in terms of oncological and clinical results, with a lower rate of abdominal postoperative hernias and occlusive/subocclusive episodes.

A regular prospective clinical follow-up through periodic medical visits and complementary tests established by the criteria of the Colorectal Cancer management protocol (document agreed by the HSCSP Colorectal Tumors Committee) will be conducted.

For the economic evaluation, all direct in-hospital costs that were registered by the HSCSP management will be analysed.

Extensive written information and an informed consent about the study will be provided to the patient.

The study does not entail any risk for the patient as it does not interfere with the usual follow-up or require extraordinary complementary studies.

The study was a parallel group trial with a 1:1 allocation ratio.

Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy

Long-term Clinical Results and Direct Economic Implication Within the Randomized Clinical Trial Comparing Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy

Percentage of patients alive after a 3-years follow-up-period since the laparoscopic right colectomy is performed

Percentage of patients alive without any type of recurrence (local or distant) after a 3-years follow-up-period since the laparoscopic right colectomy is performed

Percentage of patients that experiment disease recurrence which is placed in the previously operated area

Percentage of patients that experiment disease recurrence which is placed in a different area from the previously operated region (intraperitoneal, liver, lung metastases, etc)

Percentage of patients that present an abdominal hernia settled on any of the incisions performed during the laparoscopic right colectomy

Percentage of patients that experiment mechanical impairment or complete arrest of the passage of contents through the intestine due to pathology that causes blockage of the bowel.

Price (in euro) of the material used in the operating room in each procedure

Price (in euro) of the total amount of hours of surgical time per each procedure

Price (in euro) of the total amount of days of hospitalization per each group

Price (in euro) of the total amount of days of hospitalization in Intensive Care Unit per each group

Price (in euro) of the total amount of costs related to laboratory and diagnosis during the hospitalization period, per each group

Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau

Symptoms and General Pathology

Adenocarcinoma

Adenoma

Colonic Polyps

Polyps

Rectal Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Patients with neoplastic lesions less than 30mm unresectable en bloc by other less invasive endoscopic techniques, including lesions suggestive of T1 colorectal cancer, subepithelial tumors, lesions with diverticular involvement, lesions with no-lifting sign (recurrent, incomplete prior resection or untreated lesions).

Endoscopic full-thickness resection (EFTR) with Over-The-Scope-Clip in colorectal lesions

Endoscopic full-thickness resection

Hugo I. Uchima Koecklin, MD

Magin Farré Albadalejo

Javier Sola Vera

Ignasi Puig del Castillo

Alejandro Fernández

Alfredo Mata Bilbao

David Barquero

Jorge Carlos Espinós

Fernando Sábado

Francisco Martín

Eduardo Albéniz

Maria Pellisé

Joaquín Rodríguez Sánchez

Javier García Lledó

José Miguel Esteban

José Carlos Marín Gabriel

Pedro De María Pallarés

Pedro J. Rosón

Miguel Fraile López

Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC) as a closure mechanism is a recent technique that allows the endoscopic resection of colonic lesions that are poor candidates for conventional endoscopic resection techniques. The aim is to study the safety and efficacy of EFTR in colon.

Early detection and endoscopic resection of early neoplastic lesions in colon can prevent the development of colon cancer.

The classic endoscopic mucosal resection technique and the submucosal dissection technique require the creation of a submucosal "cushion" by injecting crystalloid substances or colloids. However, these advanced techniques have technical limitations when facing a lesion that presents poor lifting or non-lifting at all as it might be observed in scarring or fibrotic lesions

Endoscopic full-thickness resection (EFTR) in the colon using an over-the-scope clip (OTSC) is a recent technique that does not require the injection of a submucosal solution and allows a resection of colonic lesions of up to approximately 30 mm, en bloc, allowing a correct histological study of the sample, to confirm its complete resection with adequate deep margins, evaluation of the level of invasion and lymphovascular involvement.

EFTR with OTSC allows a colonic wall full-thickness resection, by the deployment of an over-the-scope clip before the resection of the lesion to prevent perforation. The steps of the technique are: face the lesion and marking the borders, insertion of the scope with the kit (consisting of a cap with an integrated snare and OTSC), grasping and pulling the lesion into the cap, deploy the over-the-scope-clip (OTSC) and closing the integrated snare and resect.

This is a multicenter observational study on the efficacy and safety of EFTR with OTSC in colon.

The clinical, endoscopic and histological data are collected prospectively in all cases of EFTR performed in the participant centers.

Endoscopic Full-Thickness Resection In Colon

Multicenter Prospective Study of Endoscopic Full-thickness Resection (EFTR) in Colon Using Over-the-scope-clip (OTSC)

Percentage of complete en-bloc resection of the lesion without macroscopic residual tissue after completing the endoscopic full-thickness resection

Percentage of procedure-associated major adverse events: bleeding and/or perforation

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy	NCT05446558	Colon Cancer Colon Neoplasm Malignant Neopl... Colon Neoplasia Colon Neoplasm,...	Intracorporeal ... Extracorporeal ...	18 Years -	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Long-term Results in Intracorporeal Versus Extracorporeal Anastomosis in Laparoscopic Right Colectomy	NCT05446558	Colon Cancer Colon Neoplasm Malignant Neopl... Colon Neoplasia Colon Neoplasm,...	Intracorporeal ... Extracorporeal ...	18 Years -	Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Endoscopic Full-Thickness Resection In Colon	NCT03803891	Colon Neoplasm,... Colo-rectal Can... Colonic Cancer Colonic Adenoma Colorectal Canc... Colorectal Neop... Colorectal Aden... Colon Polyp Colon Lesion Colon Neoplasm	Endoscopic full...	18 Years -	Fundació Institut Germans Trias i Pujol

Spots Global Cancer Trial Database for colon neoplasm, malignant