Neoplasms

Digestive System Diseases

All Conditions

Colonic Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Gastrointestinal Agents

All Drugs and Chemicals

Herbal and Botanical

Antidiarrheals

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

Pain, Postoperative

Pain

Patients undergo robotic right colectomy with intracorporeal anastomosis.

Patients undergo robotic right colectomy with extracorporeal anastomosis.

Use of intracorporeal anastomosis technique

Use of the conventional extracorporeal anastomosis technique

Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is less invasive and thereby has the potential to improve the postoperative course of right colonic cancer patients.

The objective of this study is to compare robotic right colectomy with either ICA or ECA in a randomized controlled setting.

INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy

Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy - a Double-blinded Randomized Controlled Trial

Continuously ECG-monitoring intraoperatively and postoperatively

Measuring changes in expression of ROS and immulogical genes due to surgery.

Herlev and Gentofte Hospital

Infections

Adenocarcinoma

Communicable Diseases

Surgical Wound Infection

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

In this group, the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.

In this group, the anastomosis is performed by pulling out the bowel through a laparotomy.

Byung Soh Min

STUDY DESIGN This study is a prospective, randomized, multi-center study comparing intracorporeal versus extracorporeal anastomosis in performing laparoscopic right colectomy. The study subjects will be randomly assigned to 1. intracorporeal anastomosis (experimental group) 2. extracorporeal anastomosis (control group) with 1:1 manner. After surgery the subjects will be followed up at 1month, after then, every 3 month in total 3 years.

STUDY POPULATION

1. Screening A detailed review of the medical records will be performed to assess inclusion/exclusion criteria for all subjects who have been diagnosed with right colon tumor (malignant or benign) or benign disease (complicated diverticulitis and so on) that are subject to a right colectomy procedure.

All patients who are eligible, meet the inclusion and none of the exclusion criteria of this study, will be offered enrollment into the study at each site.

RISK ANALYSIS

1. Potential risks All these procedures are in practice today and only surgeons competent in a technique shall be allowed to perform those surgeries. Therefore, there are no anticipated additional risks than would normally be encountered from these surgeries when they are performed for these patients.
2. Potential benefits There may be some benefit due to having closer follow-up in the study.

QUALIFICATION OF PARTICIPATING SURGEONS

1. Surgical procedure

   * Laparoscopic surgery: a surgical technique where operations are performed far from their target anatomy location through small incisions normally less than 15mm.
   * Extracorporeal anastomosis: the anastomosis is performed by pulling out the bowel through a laparotomy.
   * Intracorporeal anastomosis: the anastomosis is performed inside the abdominal cavity with a laparoscopic technique. Specimen extraction will be done through Pfannenstiel incision or similar incision in lower abdomen.
2. Procedure standardization and qualification procedure Participating surgeons should complete the learning curve of the procedure and experience at least 50 laparoscopic right colectomy. They are required to be evaluated by the quality control (QC) committee. They should submit their unedited videos of laparoscopic right colectomy and must be accepted by 2 or more of total 3 QC committee members.

STATISTICAL ANALYSIS Based on attaining a success rate of 85% for the primary endpoint, a total of 106 subjects will be required for each group. Accounting for a 5% loss, a total of 241 subjects will be recruited for this study.

STUDY METHODS

1. Ethical committee approval The study protocol, patient informed consent form and other required study documentation will be reviewed and approved by an institutional review board or any other authority body, prior to study start-up.
2. Study duration and enrollment The total study duration will be approximately 5 years. Study enrollment will take approximately 24 months. The study subjects will have a short-term follow-up at 30 and 3 months post procedure, with long term follow-up upto 3 years after surgery. Surveillance will be performed according to standard follow-up guideline after colorectal cancer surgery.
3. Randomization All the enrolled subject will be randomly assigned to one of the study group (intracorporeal or extracorporeal). The randomization will be performed upon the enrollment at the central institution stratifying center on 1:1 manner by a coordinator who is not aware of any clinical information
4. Data collection Data will be collected at baseline, operative procedure, discharge, 1 month, 3 months and 1 year. A screening log will be maintained at each site during the enrollment period, in which all patients eligible for the trial shall be identified. This will be maintained to ensure no patient selection bias occurs within a center or by a surgeon.
5. Informed Consent Using the study-specific, IRB approved, informed consent form, information pertinent to this study will be provided to the subjects in writing and in their native, non-technical, language. The consent form will include a description of the study and its purpose, potential benefits, potential risks, site contact information, and all other elements required of an informed consent.

   Subjects are required to voluntarily sign the informed consent form before any study-specific procedure is performed. The Investigator and/or his/her authorized designee, trained on the protocol and performing a consent, will conduct the informed consent process and will answer questions the subjects may have. If the subject agrees to participate, the informed consent form must be signed and dated by the subject or his/her legally authorized representative prior to enrollment in the study and separately signed and dated by the person taking consent. Only subjects who have signed the study informed consent will be included in the study.
6. Withdrawal and discontinuation The subject's participation in any clinical trial is voluntary. The subject has the right to withdraw at any time without penalty or loss of benefit. Study withdrawal means the subject is no longer participating in the study and no further follow-ups will be performed. All subjects that withdraw after informed consent is signed will be evaluated at the time of withdrawal. Every effort will be made to document the subject outcome at the time of withdrawal. The investigator has the right to discontinue subjects from the study at their discretion to ensure wellbeing of the subject. The reasons for withdrawal shall be documented.

This study is a prospective, randomized, multi-center study comparing intracorporeal versus extracorporeal anastomosis in performing laparoscopic right colectomy. The study subjects will be randomly assigned to: 1. Intracorporeal anastomosis 2. Extracorporeal anastomosis

Intracorporeal Versus Extracorporeal Anastomosis In Laparoscopic Right Colon Resection

Intracorporeal Versus Extracorporeal Anastomosis In Laparoscopic Right Colon Resection: A Prospective Randomized Multi-center Clinical Trial

The efficacy of the anastomosis technique is defined as a lack of surgical site infection within 30 postoperative days.

1. Superficial surgical site infection
2. Deep surgical site infection

1. The distance from the tumour and the closest bowel wall to the high vascular tie (mm)
2. The length of colon and ileum (mm)
3. The area of mesocolon (mm2)
4. Macroscopic quality of specimen (3 grades) G1 : intact mesocolon G2 : significant mesocolic disruptions away from the muscularis G3 : significant disruptions extending down to the muscularis

Yonsei University

Behaviors and Mental Disorders

Quality of Life

After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected and a side-to-side anastomosis is fashioned with a laparoscopic stapler.

After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. Then, a primary ileocolic side-to-side handsewn or mechanical anastomosis is fashioned extracorporeally.

After complete right colon mobilization and ileocolic and right colic vessels ligation, the proximal transverse colon and the terminal ileum are transected with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The antimesenteric side of the stapled ends of the transverse colon and terminal ileum are approximated by a stay suture tied intracorporeally and then held by the assistant. An antimesenteric enterotomy and an antimesenteric colotomy are made about 10 cm distal to the stapled ends of the transverse colon and terminal ileum, respectively. A side-to-side anastomosis is fashioned with a laparoscopic EndoGIA TM stapler (Covidien Medtronic). The enterotomies are then closed by two layers of reabsorbable sutures tied intracorporeally. The specimen is delivered through a small Pfannenstiel or a median incision. A big dressing covering all incisions will be applied, similar to that used for the EIA group.

Laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA)

After complete right colon mobilization and ileocolic and right colic vessels ligation, the terminal ileum, right colon, and proximal transverse colon are exteriorized for bowel division through a small midline skin incision in the upper abdomen. A primary ileocolic side-to-side handsewn or mechanical (with GIA stapler - Covidien Medtronic) anastomosis is fashioned and the bowel returned to the abdominal cavity. After reinduction of pneumoperitoneum, the lack of twists of the ileocolic anastomosis is checked. A big dressing covering all incisions will be applied.

Laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA)

Marco E Allaix, MD, PhD

Mario Morino, MD

Giuseppe Giraudo, MD, PhD

Alberto Arezzo, MD

Simone Arolfo, MD

Maurizio Degiuli, MD

Massimiliano Mistrangelo, MD, PhD

Roberto Passera, MD

Marco A Bonino, MD

During the last few years, the laparoscopic right colectomy with intracorporeal ileocolic anastomosis (IIA) has been proposed as an alternative to laparoscopic right colectomy with extracorporeal ileocolic anastomosis (EIA) for the treatment of right colon tumors. However, the level of evidence coming from the currently available literature is low, based on the results of a few small and heterogeneous retrospective non-randomized studies. A randomised controlled trial is warranted to challenge these two procedures. The aim of this randomized controlled trial is to assess the outcomes after IIA or EIA after laparoscopic right colectomy for right colon tumors.

While there are no differences in oncologic principles (no touch technique, proximal vessel ligation, lymphadenectomy) between laparoscopic right colectomy with IIA and EIA, potential advantages of IIA are: (1) no need for extensive mobilization of the transverse colon to reach the abdominal wall; (2) performing the anastomosis away from the abdominal wall may lead to reduced rates of superficial site infection; (3) a shorter incision for the specimen extraction may be associated with clinical benefits such as less pain and lower rates of superficial site infections; (4) laparoscopic visualization during the creation of the IIA may reduce unrecognized twisting of the terminal ileum mesentery, and (5) the ability to remove the specimen through any type of incision, with subsequent reduced risks of incisional hernias in case of Pfannenstiel incision when compared to midline or off-midline incisions.

Some retrospective and heterogeneous studies comparing perioperative outcomes after laparoscopic right colectomy with EIA and IIA have been published in the last decade, reporting controversial results. Furthermore, the results of recent metanalyses are challenged by the heterogeneity and the poor quality of the published studies. Lastly, no comprehensive economic evaluation of the two procedures have been performed yet.

Consecutive patients with right colon tumors are included in a randomized controlled trial. This is a single Institution prospective randomized controlled trial comparing the outcomes in patients undergoing laparoscopic right colectomy with IIA or EIA for right colon neoplasm. Eligible patients will be randomly assigned in a 1:1 ratio to undergo either laparoscopic IA or EA according to a list of randomization numbers with treatment assignments. This list will be computer generated. An Internet application will allow central randomization.

Cost analysis will be based on the following costs: surgical instruments (including re-usable trocars and disposable tools), operative room, routine postoperative surgical care, diagnosis and treatment of postoperative complications. Operative room costs include healthcare personnel, medications, and structure costs. To calculate the cost of each postoperative complication, the following items will be assessed: laboratory and microbiology analysis; medical, technical, and diagnostic services; surgical and therapeutic interventions; medications; prolonged hospital stay, and outpatient clinic follow-up. The mean length of hospital stay of uncomplicated patients will be the basis to calculate the prolonged hospital stay in each patient with complication. In patients who will develop multiple complications, resources used to treat each complication will be recorded separately.

A big dressing covering all incisions will be applied at the end of each operation in both arms.

Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.

Intracorporeal or Extracorporeal Ileocolic Anastomosis After Laparoscopic Right Colectomy.

evaluation of the number of lymph nodes in the specimen on pathology report

percentage of patients requiring narcotics after surgery

Cost analysis will be based on the following costs: surgical instruments (including re-usable trocars and disposable tools), operative room, routine postoperative surgical care, diagnosis and treatment of postoperative complications. Operative room costs included healthcare personnel, medications, and structure costs. To calculate the cost of each postoperative complication, the following items will be assessed: laboratory and microbiology analysis; medical, technical, and diagnostic services; surgical and therapeutic interventions; medications; prolonged hospital stay, and outpatient clinic follow-up. The mean length of hospital stay of uncomplicated patients will be the basis to calculate the prolonged hospital stay in each patient with complication. In patients who will develop multiple complications, resources used to treat each complication will be recorded separately.

the SF-12 questionnaire will assess quality of life

University of Turin, Italy

Professor

Laparoscopic right hemicolectomy with Extracorporeal anastomosis in patients with colon cancer.

Laparoscopic right hemicolectomy with Intracorporeal anastomosis in patients with colon cancer.

Laparoscopic right hemicolectomy will be carried out. The dissection is performed laparoscopically. When the right hemicolon is sufficiently mobilized and the vessels (ileocolic pedicle, right colic pedicle and the right branch of the middle colic pedicle) are ligated, a horizontal incision in the upper right quadrant is made. Through this incision the right hemicolon is extracted, the small bowel and the transverse colon are divided using staplers. The side-to-side ileocolic anastomosis is then handsewn.

Laparoscopic right hemicolectomy will be carried out. The dissection is performed laparoscopically. The right hemicolon is mobilized and the vessels (ileocolic pedicle, right colic pedicle and the right branch of the middle colic pedicle) are ligated. The small bowel and the transverse colon are then divided using laparoscopic staplers. The side-to-side ileocolic anastomosis is formed by creating a small opening in the small bowel and the transverse colon, through which the laparoscopic stapler is used to join the bowel ends. The remaining opening is sutured laparoscopically. The specimen is retrieved through a Pfannenstiel incision.

Benedicte Schelde-Olesen, MD

In this study, the investigators will compare extracorporeal anastomosis (EA) with intracorporeal anastomosis (IA) in patients undergoing elective laparoscopic hemicolectomy for right colon cancer.

At Odense University Hospital, Svendborg, current standard treatment for right colon cancer is laparoscopic hemicolectomy with extracorporeal anastomosis (EA).

To reduce the risk of adverse events, such as fascial dehiscence and later development of incisional hernia, right hemicolectomy with intracorporeal anastomosis has been introduced.

When performing a laparoscopic right hemicolectomy the dissection is carried out intracorporeally and the transection and anastomosis is made extracorporeally (EA technique). For IA technique the cancer bearing segment is resected and the bowel ends joined intracorporeally with laparoscopic technique, and the specimen is then retrieved through a Pfannenstiel incision.

Previous series have shown shorter hospital stay as well as shorter time to bowel recovery in patients treated with IA compared to EA, without increasing the risk of severe complications or compromising the oncological outcome.

The aim of this study is to investigate whether IA in patients undergoing right hemicolectomy reduces the overall complication rate compared to EA evaluated by Comprehensive Complication Index (CCI) .

51 patients will be enrolled in each group.

Prospective, single center, non-randomized, non-blinded

Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer

Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer - A Prospective Cohort Study

According to the Comprehensive Complication Index (CCI) based on the Clavien Dindo classification of postsurgical complications.

CCI is a continuous scale from 0-100 (0 equals no complications, 100 equals death)

Evaluated by C-reactive protein (CRP), leucocytes and National Early Warning Score (NEWS).

NEWS is an aggregate scoring system, based on physiological measurements, designed to help detect acute illness. Minimum score of 0 indicates normal measurements. The score increases with further deviation from the norm, with a maximum score of 20.

Measured in hours from end of surgery to first flatus and first bowel movement respectively

Measured in hours from end of surgery until the patient is discharged

Registered daily using Visual analogue scale (VAS) for pain. The scale ranging from 0-10, 0 being no pain, 10 being worst pain imaginable.

Based on CT scans 1 and 3 years post surgery

University of Southern Denmark

Principal investigator

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
INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy	NCT03130166	Colonic Cancer	Intracorporeal ... Extracorporeal ...	-	Herlev and Gentofte Hospital
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
Intracorporeal Versus Extracorporeal Anastomosis In Laparoscopic Right Colon Resection	NCT05077358	Adenocarcinoma ...	Intracorporeal ... Extracorporeal ...	19 Years -	Yonsei University
Intracorporeal Versus Extracorporeal Anastomosis In Laparoscopic Right Colon Resection	NCT05077358	Adenocarcinoma ...	Intracorporeal ... Extracorporeal ...	19 Years -	Yonsei University
Intracorporeal or Extracorporeal Anastomosis After Laparoscopic Right Colectomy.	NCT03045107	Colon Cancer Anastomosis	Laparoscopic ri... Laparoscopic ri...	18 Years -	University of Turin, Italy
Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer	NCT05039762	Colon Cancer	Extracorporeal ... Intracorporeal ...	18 Years -	University of Southern Denmark
Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer	NCT05039762	Colon Cancer	Extracorporeal ... Intracorporeal ...	18 Years -	University of Southern Denmark
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

Spots Global Cancer Trial Database for extracorporeal anastomosis