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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

Surgical outcomes after laparoscopic intracorporeal versus for right and left hemicolectomies in management of colonic cancers

Surgical outcomes after laparoscopic extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers

laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers

laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies

Abdullah AA Abdullah, M.B.B.Ch,M.Sc

Omar AS AlTabary, professor

Omar AS Al tabary, professor

Abd El-Aal AS Mahran, Assistant professor

Ahmed A Aldardeer, Lecturer

Ahmed Farag, professor

Omar AS Al tabary, Professor

The aim of this study is to compare the Surgical outcomes after laparoscopic intracorporeal versus extracorporeal anastomosis for right and left hemicolectomies in management of colonic cancers .

This is clinical trial ,Interventional quasi experiment study to evaluate the surgical outcomes between intracorporeal versus extracorporeal anastomosis in laparoscopic right and left hemicolectomies including post operative pain, hospital stay, leakage from anastomosis, early recurrence, hernias patient satisfaction operative time and more surgical outcomes.

In Egyptian hospitals. Source of data the investigators follow up and medical reports and more . surgical procedures This trial including two groups of patients with right and left cancer colon undergoing Laparoscopic colectomy. First group (A) will be operated as intracorporeal anastomosis while the second group (B) will be operated as extracorporeal anastomosis.

Sample size more than 50 person Statistical analysis plan Statistical Package for the Social Sciences (SPSS) program

right and left hemicolectomies in colonic cancers

Laparoscopic Colectomies In Management of Colonic Cancers

Surgical Outcomes After Laparoscopic Intracorporeal Versus Extracorporeal Anastomosis for Right and Left Hemicolectomies In Management of Colonic Cancers

intraoperative time of surgery by minutes

Post operative leakage of anastomosis by follow up ultrasound, Abdominal Xray erect \& wound infection

early recurrence of the cancer by CT scan

Sohag University

Assistant lecture general surgery

Rectal Diseases

Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.

Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction.

Robot-assisted surgery (RAS), allows many types of complex MIS procedures using robotic systems to aid in surgical procedures providing more precision, flexibility and control than is possible with other MIS techniques.

Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.

Intracorporeal anastomosis: when the anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique. A Pfannenstiel incision will be done exclusively for specimen extraction.

Laparoscopic surgery, also called minimally invasive surgery (MIS), or keyhole surgery, is a surgical technique in which operations are performed far from their location through small incisions (usually 0.5-1.5 cm) elsewhere in the body.

Extracorporeal anastomosis: when the anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Anastomosis is performed by pulling out the bowel through a laparotomy wherever that laparotomy is performed.

Extracorporeal Anastomosis

Anastomosis is performed inside the abdominal cavity with a laparoscopic or robotic technique

Intracorporeal Anastomosis

Procedure is performed using robotic instruments

Robotic Surgery

Procedure is performed using standard laparoscopic instruments

Laparoscopic Surgery

Marcos Gómez Ruiz, MD PhD

Lucía Lavín Alconero, BSc PhD

Arto Turunen

Pälvi Vento

Jyrki Kössi

Tero Rautio

Tarja Pinta

Anne DUBOIS

Philippe ROUANET

Benoit ROMAIN Benoit

Laurent BRESLER

Markus Winny

Thalia Petropoulou

Andrea Coratti

Paolo Pietro Bianchi, MD PhD

Wanda Luisa Petz

Dominico D´Ugo

Antonino Spinelli

Dario RIBERO

Nuno Rama

Antonio Arroyo Sebastián, MD

Antonio Arroyo Sebastián

Nuria Truan Alonso

Marcos Gómez Ruiz, MD

Carmen Cagigas Fernández

Julio José Del Castillo Diego

Joaquin Alonso Martín

Lidia Cristobal Poch

Manuel Gómez Fleitas

Marcos Gómez Ruiz

Eloy Espin

Franco Marinello

Carlos Placer Galán

José María Enriquez Navascues

Pedro Antonio Sanchez Fuentes, MD

Angel Reina Duarte

Francisco Rubio Gil

Manuel Ferrer Marquez

Vicente Simó Fernández

Mauricio García Alonso, MD

Oscar Cano Valderrama

Mauricio García Alonso

Eduardo Rubio Gonzalez

Oscar García Villar

María Labalde Martinez

Jim Kahn

Galo Peralta, MD

Right colectomy (hemicolectomy) involves the removal of the cecum, the ascending colon, the hepatic flexure, the first one-third of the transverse colon, part of the terminal ileum, and the associated regional fat and lymph nodes, and is the accepted treatment for malignant neoplasms of the right colon.

A minimally invasive approach is commonly used for right colectomy, with studies reporting reduced complications, less blood loss, and hospital stay when compared to an open approach.

However, there remains controversy regarding whether robotic assistance is advantageous for this technique and whether an intracorporeal (ICA) or extracorporeal anastomosis (ECA) is best.

MIRCAST is a prospective, observational, international, multi-center, 4-parallel-cohorts study. Sites or surgeons will select a cohort of the study for which they are qualified. Four cohorts will be the subject of study:

1. Robotic Right Colectomy with ICA
2. Robotic Right Colectomy with ECA
3. Laparoscopic Right Colectomy with ICA
4. Laparoscopic Right Colectomy with ECA

All patient assessments will be done according to the sites standard of care. Parameters routinely recorded during right colectomy surgery will be collected prospectively. Enrolled subjects will undergo assessments at the following intervals: pre-operative, operative, discharge, 30 days, 3 months, 1 year and 2 years post-surgery.

MIRCAST study is an observational, prospective, parallel cohorts, international, multi-center to compare robotic assisted and laparoscopic minimally invasive right colectomy, and intracorporeal anastomosis versus extracorporeal anastomosis.

The research is coordinated by Marcos Gómez Ruiz MD PhD from Hospital Universitario Marqués de Valdecilla in Santander, Spain; the sponsorship is performed by Fundacion Instituto de Investigación Marqués de Valdecilla (IDIVAL). The European Society of Coloproctology (ESCP) endorses MIRCAST Study and will run a quality audit/independent monitoring of the study.

The objectives of study are to compare of the peri-operative complications after robotic assisted and laparoscopic minimally invasive right colectomy with intracorporeal anastomosis versus extracorporeal anastomosis.

To Identify potential benefits of robotic assisted procedures for right colon resections.

Minimally Invasive Right Colectomy Anastomosis Study

A Prospective Observational Multi-center 4 Cohort Study Comparing Robotic Assisted and Laparoscopic Invasive Right Colectomy and Intracorporeal Anastomosis Versus Extracorporeal Anastomosis

PCT values on postoperative dates 1, 3 and 5

Time until patient gets out of bed and engages in light activity (such as sitting, standing, or walking)

o Time to start working/activity at patient´s job again

Visual analogue scale (VAS) scores at postoperative days. Scores will range from 0 to 10 (0 no pain and 10 a pain you would rather prefer to die).

(CDC definition \[Health Protection Agency. Surveillance of Surgical Site Infection in England: October 1997-September 2005. London: Health Protection Agency; 2006): Superficial incisional, affecting the skin and subcutaneous tissue. These infections may be indicated by localised (Celsian) signs such as redness, pain, heat or swelling at the site of the incision or by the drainage of pus.

Complications according to Clavien Dindo Classification.

The length of time from either the date of diagnosis or the start of treatment for a disease, such as cancer, that patients diagnosed with the disease are still alive

Length of time after primary treatment for a cancer ends that the patient survives without any signs or symptoms of that cancer.

Rate of cancer that has recurred at or near the same place as the original (primary) tumor

Rate of Cancer that has spread from the original (primary) tumor to distant organs or distant lymph nodes

When anything apart of the anastomosis had to be done through the laparotomy. If the anastomosis is not completely performed in an intracorporeal approach, the case is considered also converted

Operative time from skin to skin in minutes

Complete Mesocolic Excision is defined as complete resection of the mesocolon with its anatomical envelope. Anatomical report should include any defect on CME specimen (Hohenberger W, Weber K., Matzel K., Papadopoulost T., Merkel S. Standardized surgery for colonic cancer: complete mesocolic excision and central ligation - technical notes and outcome. Colorectal Disease 11, 354-365 2008. doi:10.1111/j.1463-1318.2008.01735.x)

Number of harvested Lymph nodes according to the definitive pathological report.

Rate of resection without any affected margins during the surgical procedure.

In hospital stay of the patient from the day that they are admitted before surgery to the day that they are fit to leave the hospital after the procedure.

Incidence of ventral hernia 1 year after the procedure and 2 years after the procedure at the laparotomy site.

Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-C30 Score 3 months and 1 year after the procedure.

Quality of Life Questionnaire (QLQ) of the European Organisation for Research and Treatment of Cancer (EORTC) QLQ-CR29 Score 3 months and 1 year after the procedure.

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
Laparoscopic Colectomies In Management of Colonic Cancers	NCT04972994	Laparoscopic Co... Cancer Colon Intracorporeal ...	laparoscopic in...	20 Years - 90 Years	Sohag University
Minimally Invasive Right Colectomy Anastomosis Study	NCT03650517	Colorectal Canc... Anastomotic Com... Colectomy	Extracorporeal ... Intracorporeal ... Robotic Surgery Laparoscopic Su...	18 Years -	Instituto de Investigación Marqués de Valdecilla

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