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Following the principle of complete mesocolic excision(CME), Ileocecus-Sparing Right colectomy refers to the resection of the most portion of the ascending colon, hepatic flexure and mid to distal transverse colon. The extent of lymph node dissection and length of distal resection margin are similar to conventional right hemicolectomy. The length of proximal resection margin varies.

The ileocecal artery(ICA) is skeletonized. The colic branch of ICA is divided and ligated. Preserve anterior cecal artery, posterior cecal artery and ileocecal branch of ICA. Divide and ligate the right colic artery(RCA) and middle colic artery(MCA) at their roots. Dissect the lymph nodes surrounding the ICA, RCA and MCA accordingly. Head-to-Head colocolic anastomois is done, with circular stapler via making an opening at the bottom of cecum.

laparoscopic ileocecus-sparing right hemicolectomy

KeFeng Ding, PhD

To investigate whether laparoscopic ileocecus-sparing right hemicolectomy is feasible and oncologically safe

Our study is a single arm, single center clinical trial. The enrolled patients will accept laparoscopic ileocecus-sparing right hemicolectomy. The primary endpoint: postoperative complications, 1-year local recurrence. The second endpoint: conversion to conventional right hemicolectomy, time to first flatus after surgery, number of harvested lymph nodes, 3-year disease free survival, R0 resection, Specimen morphometry

Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon

An Open, Single-arm, Single Center, Clinical Trial to Investigate the Feasibility and Safety of Laparoscopic Ileocecus-sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon

Postoperative complications used to calculate the Comprehensive Complication Index (CCI) will be recorded

rate of local recurrence one year after surgery, including anastomotic recurrence, recurrence around ileocolic vessels and surgical trunk of superior mesenteric vein,

the rate of conversion to conventional right hemicolectomy

days from a colectomy procedure to first occurrence of flatus during subject's postoperative recovery

Number of harvested Lymph nodes according to the pathological report

Rate of resection without any affected margins during the surgical procedure according to the pathological report

The gross dimensions of resected specimen: length, the distal and proximal resection margins distance, vascular pedicle length

the time from enrollment until disease relapse or death from any cause 3 years after surgery

Zhejiang University

Professor

Carcinoma

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Cutting the peritoneum along the line between the right mesocolon and retroperitoneum, enter the Toldt's space to dissect the posterior of Superior mesenteric vein（SMV）and Superior mesenteric artery（SMA）and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein（SMV）. In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called caudal-to-cranial approach.

First, the pedicle of ileocolic vessels is identified and the mesocolon is dissected between the pedicle and the periphery of the Superior mesenteric vein（SMV）to expose the second portion of the duodenum. The ileocolic vessels are then cut at their roots. The ascending mesocolon is separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon.This approach is the medial-to-lateral(MtL) approach

Cutting the peritoneum along the line between the right mesocolon and retroperitoneum, enter the Toldt's space to dissect the posterior of Superior mesenteric vein and Superior mesenteric artery and their branches, and then finished the D3 dissection from caudal to cranial on both sides of the mesentery along the Superior mesenteric vein. In the end, cut the lateral ligament to mobilize the posterior space of ascending colon. This approach is called the caudal-to-cranial approach.

the caudal-to-cranial approach

First, the pedicle of ileocolic vessels is identified and the mesocolon is dissected between the pedicle and the periphery of the Superior mesenteric vein to expose the second portion of the duodenum. The ileocolic vessels are then cut at their roots. The ascending mesocolon is separated from the retroperitoneal tissues, duodenum, and pancreatic head up to the hepatocolic ligament cranially. The important detail in this procedure is the wide separation between the pancreatic head and the transverse mesocolon.This approach is the medial-to-lateral(MtL) approach

the medial-to-lateral approach

Liao-nan Zou, MD.

liao-nan Zou, MD

xin-quan Lu, MD

Liao-nan Zou, professor

Jin Wan, PhD

To investigate the clinical application value of laparoscopic radical right hemicolectomy using the caudal-to-cranial approach versus the medial-to-lateral approach by prospective randomized controlled clinical study.

To compare the caudal-to-cranial approach with the medial-to-lateral approach in laparoscopic right hemicolectomy for the advance right colon cancer.

A prospective randomized controlled trial will be performed in the GI department,the Guangdong provincial hospital of Chinese Medicine from October 2016 to October 2024.The sample size，150 cases with advanced right colon cancer, will be needed after calculated by the statistics .The 150 cases will be randomly divided into two groups: laparoscopic radical right hemicolectomy using the caudal-to-cranial(CtC) approach(GroupCtC) and laparoscopic radical right hemicolectomy using the medial-to-lateral(MtL) approach (GroupMtL). Primary outcomes are the operative time，The secondary outcomes are the total blood loss,the number of lymph nodes dissected,the average time of ground activities,the time to first flatus,the hospital stay,the intra-operative complication and the post-operative complication，and others' outcomes are the Disease-free survival rate(DFS) at 3 years and 5 years,the Overall survival rate（OS）at 3 years and 5 years.The data in two groups will be compared.

A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach

A Prospective Randomized Controlled Clinical Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach

Guangdong Provincial Hospital of Traditional Chinese Medicine

professor

Rectal Diseases

Central Nervous System Depressants

Anesthetics

Laparoscopic right hemicolectomy for cancer. .For the IA group, colon, transverse mesocolon, ileum and terminal ileum mesentery will be resected intracorporeally through a 45 mm endoscopic linear stapler with vascular cartridge. Then, the linear stapler will inserted through two small enterotomies and a mechanical ileo-transverse, side-to-side isoperistaltic intracorporeal anastomosis performed using the vascular cartridge with six rows of closely placed staples. The enterotomies will be then closed using a double layered continuous intra corporeal manual suture with 3-0 Polyglactin 910. The mesenteric defects will be left open. The specimen will be placed in a protective plastic bag and then extracted through a Pfannestiel incision.

Laparoscopic right hemicolectomy for cancer. In the EA group, the bowel will be externalized by widening the incision of one of the trocars or by performing a mini-laparotomy at another location (subcostal, suprapubic) protected with a plastic sheet. The ileum and colon will be then resected through a 45 mm endoscopic linear stapler with vascular cartridge (staple height = 3.85 mm) and a side-to-side isoperistaltic mechanical anastomosis will be then performed using the same vascular cartridge. The enterotomies will be then closed using a double layered continuous manual suture using a 3-0 Polyglactin 910.

In both groups, a drain will not routinely inserted.

After induction of anesthesia, a foley catheter and an NG tube will be inserted. All patients will have their NG tubes removed after the procedure. During the procedure patients will be placed in Trendelenburg position with 15 degrees of tilt and with a right side up (tilt to the left of 25 degrees). A Veres needle will be inserted and pneumoperitoneum induced and maintained at 12 mmHg for the entire duration of the procedure. Under direct vision, three 10-12mm trocars will be inserted in the left abdominal wall. The ileocolic vessels, the right colic vessels (when present), the right branch of the middle colic vessels and the right gastroepiploic vessels will be ligated intracorporeally at their origin using clips. Anastomosis are described in each arm description.

Laparoscopic right hemicolectomy for cancer

Francesco Feroci, MD

Elisa Lenzi, MD

Andrea Vannucchi, MD

Alessia Garzi, MD

Maddalena Baraghini, MD

Marco Scatizzi, MD

Stefano Cantafio, MD

The aim of this systematic review is to compare intracorporeal (IA) versus extracorporeal anastomosis (EA) after laparoscopic right hemicolectomy for cancer.

Background. Only a few retrospective publications comparing these anastomotic techniques and no randomized clinical trial has been performed. We conducted a meta-analysis of the existing non randomized comparative studies on the argument: the results suggest that the IA results in better postoperative recovery outcomes, such as shorter hospital stay, faster bowel movement recovery, faster first flatus, faster time to solid diet and lesser analgesic usage.

Design: Two-armed, double-blinded, randomized, controlled study.

The patients will be randomized into two groups:

A. After laparoscopic right colectomy for cancer, anastomosis will be carried out intracorporeally (IA) B. After laparoscopic right colectomy for cancer, anastomosis will be carried out extracorporeally (EA)

Primary endpoint: Surgical morbidity rate defined as any diagnosed morbidity related to surgical technique (anastomotic leakage, anastomotic bleeding, wound infection, ileus) within 60 days from surgery.

Secondary endpoints:

* Intra-operative: operative time, largest incision length (mm), number of nodes harvested, intraoperative complications.
* Early postoperative: mortality, non-surgical site complications.
* Postoperative recovery: bowel movement, first flatus, time to solid diet, nasogastric tube (NGT) reintroduction, day of analgesic usage, length of stay, readmission.

Randomization. The randomization will be obtained through a computer generated program (GraphPad Software, Inc, La Jolla, California, USA). The randomization, will be done before the beginning of the study and it will consist with an ordered series of numbers with a corresponding letter: A for intracorporeal anastomosis and B for extracorporeal anastomosis. This series of numbers will be kept in a central dedicated web database; after right colon cancer diagnosis, if the patient fulfills the inclusion criteria and signs the consent a number, progressive as in order of inclusion, will be assigned to him or her. The letter corresponding to the number, and hence the type of procedure to perform, will be notified to the operating surgeon, who will proceed accordingly.

Blinding. A second surgeon team (different from the one who participate in the intervention), aware of the operative findings but not the management of the anastomosis, will then assume the care of the patient. Postoperative care and ability to be discharged from the hospital will be determined by the second surgical team. This second surgical team will be blinded to the kind of anastomosis. The primary operative team will be in every moment available for emergent consultation.

Power Calculation. The reported prevalence of surgical morbidity after laparoscopic colectomy varies widely from 5-15%16-39, usually depending on the definition of complications and the type of resection performed. The most recent Cochrane review on the argument indicates a 8.6% of local morbidity (Wound infection, anastomotic insufficiency, postoperative ileus, postoperative bleeding)40. Therefore the number of patients required was based on the hope of improving the rate of surgical morbidity from 8.6% to 4.3%; considering a drop-out rate of 5%, 384 patients (192 in the IA group and 192 in the EA group) are necessary to ensure an 80% power with an alpha of 5%, when using a two-sided log-rank test. The statistical power sample calculation was carried out using PASS 2005 (Power Analysis and Sample Size, within the statistical package "NCSS 2004 and PASS 2005").

Sixty-four patients will be included by each of the six centers of the consortium. Only surgeons with at least 30 right colectomies performed with intracorporeal anastomosis will be allowed to recruit patients as first operator.

Statistics. To evaluate significance of differences between the two groups, chi-squared and Fisher's exact test will be used as appropriated for categorical variables, and the non-parametric Mann-Whitney U-test for continuous variables. Significance level will be set at 5%. The statistical analysis will be carried out using the Statistical Package for the Social Sciences (SPSS version 13; SPSS Inc. Chicago, Illinois, USA).

Monitoring. as commonly requested for Randomized Controlled Trials on patients, a strict control of outcomes has been planned during the study. Three experts in laparoscopic colorectal surgery will be designed as member of IN EXTREMO Trial Monitoring Committee. They would have access to the data during the whole course of the study and indicate cessation of the trial if one arm is providing manifestly inferior results.

INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer

INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer: a Randomized Clinical Trial. (IN EXTREMO Study)

Surgical morbidity rate defined as any diagnosed morbidity related to surgical technique (anastomotic leakage, anastomotic bleeding, wound infection, ileus) within 60 days from surgery.

Minutes from skin incision to skin closure

Incidence and kind of intraoperative morbidity

Incidence and kind of medical morbidity (cardiovascular, respiratory, or metabolic events; nonsurgical infections; deep venous thrombosis; and pulmonary embolism)

Defined as hours from surgery to peristalsis, assessement every 8 hours

Defined as hours from surgery to first flatus

Defined as hours from surgery to first stool canalization

Defined as hours from surgery to solid diet tolerance

Defined as number of days after interventions

Defined as day from surgery to dismission plus eventual days of recovery after readmission

Ospedale Misericordia e Dolce

Laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis.

Laparoscopic right hemicolectomy with extracorporeal anastomosis.

Intracorporeal anastomosis group The laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. In this procedure, intracorporeal division of the mesoileum and transverse colon is performed, as shown in the animation. The ileum and transverse colon are divided with the Endopath® Echelon Flex ™ 60 stapler. The specimen is inserted in a plastic bag. Side-to-side isoperistaltic mechanical anastomosis is performed using the same endostapler. A running suture is performed of the mechanical suture orifice, with another reinforcing suture with Monocryl ™ (poliglecaprone 25) or with STRATAFIX ™ Spiral Knotless barbed suture. The specimen is extracted through a Pfannestiel minilaparotomy (3.5-4 cm) Wound Protector

Laparoscopic right hemicolectomy with intracorporeal anastomosis.

Laparoscopic right hemicolectomy with extracorporeal anastomosis with the technical features of each center

Xavier Serra-Aracil, MD, PhD

INTRODUCTION: Colorectal cancer is the second most frequent cancer in the Western world. Roughly a third of colorectal tumors are located in the right colon, and right hemicolectomy surgery is the treatment of choice in non-disseminated right colon cancer and other benign pathologies. Despite the introduction of laparoscopy and multimodal fast-track perioperative management programs in recent years, postoperative complication rates remain high. The most serious complication is anastomotic leak (AL), which is associated with increased mortality, longer hospital stay, and reduced quality of life due to the presence of ostomies. For a long time, the importance of ileo-colic AL was underestimated. However, the ANACO study, conducted in 52 hospitals in our environment, reported a rate of AL of 8.4% with a range of 0 to 35%. This wide range is due to the differences in the surgical procedures and anastomoses used (the surgical approach may be open or laparoscopic, and the anastomosis may be manual or mechanical, with all its variations).

The results of intracorporeal laparoscopic anastomosis in the literature vary widely and, are discordant, although those reported so far estimate a DA less than 2%. But the latest publications report low rates of morbidity and of surgical space infection (SSI). The main problem with this technique is that it requires a learning curve somewhat greater than the others and its results depend on the skill of the surgeon and his casuistry. For all these reasons, it is necessary to carry out comparative studies that favor the use of this technique as gold standard.

The multicentre, controlled and randomized controlled studies have the disadvantage that randomization in centers not used with one of the techniques does include a learning curve bias. Besides the fact that in a center there is a belief that one of the techniques is superior to the other, it is not ethical to randomize the techniques. This situation has encouraged us to perform a non-randomized TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND).

Main objective:

To assess if laparoscopic right hemicolectomy, with anastomosis, obtains better results than laparoscopic with extracorporeal anastomosis and open surgery in terms of global morbidity, surgical space infection, anastomotic leak, re-interventions and hospital stay, in the first 30 postoperative days.

Secondary objectives:

To analyze the rate of anastomotic leak (AL) and organ-cavitary infections in each hospital.

* Compare the results obtained with those published in the literature.
* Try to identify the risk factors associated with AL.
* Analyze the comorbidities associated with the type of incision made for the extraction of the surgical piece, in intra and extracorporeal anastomosis

Study Design: TREND-study design (Transparent Reporting of Evaluations with Non-randomized Designs-TREND):

A multicenter prospective, non-randomized, controlled study of the intracorporeal mechanical side-to-side isoperistaltic anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy. TREND-study.

Study procedure

Intracorporeal anastomosis group The laparoscopic right hemicolectomy with intracorporeal mechanical side-to-side isoperistaltic anastomosis. In this procedure, intracorporeal division of the mesoileum and transverse colon is performed, as shown in the animation. The ileum and transverse colon are divided with the Endopath® Echelon Flex ™ 60 stapler. The specimen is inserted in a plastic bag. Side-to-side isoperistaltic mechanical anastomosis is performed using the same endostapler. A running suture is performed of the mechanical suture orifice, with another reinforcing suture with Monocryl ™ (poliglecaprone 25) or with STRATAFIX ™ Spiral Knotless barbed suture. The specimen is extracted through a Pfannestiel minilaparotomy (3.5-4 cm) Wound Protector Extracorporeal anastomosis group according to the usual technique in each center.

Expected duration of subject participation; what is done and when: Duration of the study two years.

Population

Patients diagnosed with adenocarcinoma of the right colon up to the hepatic angle after complete colonoscopy, biopsy, and chest, abdominal and pelvic CT, and chest radiography, of the participating hospitals.

Recruitment Plan

Centers intracorporeal group: Parc Taulí University Hospital, Spain. Hospital Universitario Joan XXIII de Tarragona, Spain. Hospital de Cancer de Barretos. Brazil

Centers extracorporeal group: Consorcio Hospitalario de Terrassa (Barcelona), Spain. Hospital de Universitario de Vich (Barcelona), Spain. Hospital Universitario Arnau de Vilanova de Lleida, Spain. Hospital Santa Tecla de Tarragona, Spain. Hospital Universitario Sant Joan de Reus (Tarragona), Spain.

A multicenter prospective, non-randomized, controlled study of the intracorporeal mechanical side-to-side isoperistaltic anastomosis versus extracorporeal anastomosis in laparoscopic right hemicolectomy. TREND-study

Study of the Intracorporeal Versus Extracorporeal Anastomosis in Right Hemicolectomy: HEMI-D-TREND-study

A Multicenter Controlled Study of the Intracorporeal Mechanical Side-to-side Isoperistaltic Anastomosis Versus Extracorporeal Anastomosis in Laparoscopic Right Hemicolectomy: HEMI-D-TREND-study

Percentage of anastomic leak (defined in accordance with Peel et al.).

SSI in accordance with the Center for Disease Control (CDC) National Nosocomial Infection Monitoring System

Percentage of re-interventions due to surgical complications

Mireia Pascua-Solé

Laura Mora-Lopez

Anna Pallisera-Lloveras

Sheila Serra-Pla

Ricard Sales

Beatriz Espina

Luis Romangolo

Anna Serracant

Cristina Ruiz

Mº José Mañas Gomez

Angels Montserrat-Marti

Mireia Merichal

Carlos Cerdán-Santacruz

Antonio Sanchez

Helena Vallverdú

Corporacion Parc Tauli

Head of Colorectal Unit

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.

Extracorporeal anastomosis

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.

Intracorporeal anastomosis

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

Implementation standardised laparoscopic right hemicolectomy with proctoring

Implementation standardised laparoscopic right hemicolectomy without proctoring

Alexander A.J. Grüter, MD

Usha K. Coblijn, MD, PhD

Jurriaan B. Tuynman, MD, PhD

Pieter J. Tanis, MD, PhD, Prof

Boudewijn R. Toorenvliet, MD, PhD

A surgical intervention might be highly variable amongst surgeons and centers. This variability has a potential relevance concerning clinical outcomes.

For right-sided colon cancer, the laparoscopic right hemicolectomy (LRHC) knows substantial variation. Especially since the surgical technique has been evolving during the latest decade with the introduction of intracorporeal anastomosis, a dissection technique within the correct embryological planes (complete mesocolic excision) and central vascular ligation of the segmental branches at its origin, resulting in an optimal lymph node dissection.

Given the insights from recent studies showing the association between quality of surgery and relevant clinical outcomes, there is a great need for a formative quality assessment of LRHC. Detailed objective assessment of the LRHC is currently not performed in clinical practice nor in surgical training. Quality assessment of LRHC has great potential to improve surgical training and furthermore, implementation of a standardized technique will ultimately lead to better quality of care for patients suffering from right-sided colon cancer.

The main objective of this study is to improve surgical outcomes for patient with right-sided colon cancer by a prospective sequential interventional cohort study that aims to standardize the surgical technique with subsequent controlled implementation after standardized review of the current practice in a nationwide multicenter setting. The primary endpoint is the 30-day morbidity according to the Clavien-Dindo classification system.

1. Prospective mapping of current practice with surgical variations in laparoscopic right hemicolectomy (total duration of inclusion 3 months) N= 40 centers N = 310 videos

   1. METC approval for the use of anonymized videos of a laparoscopic procedure and collection of corresponding clinical outcomes.
   2. Approaching hospitals for participation (high volume centers (50+ colon cancers).
   3. Prospective inclusion of consecutive patients undergoing laparoscopic right hemicolectomy in the participating hospitals in three months.
2. Development of Standard Laparoscopic Right Hemicolectomy: an (inter)national Delphi study

   1. Approaching specialists to participate in the Delphi method (from participating hospitals in step 1).
   2. Identification of crucial steps and measures according to literature and expert's opinion (Delphi method).
   3. Documentation of steps and the order in which they need to be performed, development of a competency assessment tool (CAT).
3. Skills center training facility

   a. Training the participating surgeons in the method of the standardized laparoscopic right hemicolectomy, as consented in the Delphi method.
4. Implementation of the standardized laparoscopic right hemicolectomy with proctoring during another period with prospective inclusion of consecutive patients with collection of surgical videos in all participating hospitals (N=40 centers, total 310 videos)

   1. Rating videos.
   2. Comparing with pre-implementation performance based on outcome measures reflecting oncological quality of surgery, and 30-day clinical outcomes.
   3. Comparing with pre-implementation performance based on the long-term outcomes. (3-year DFS and 5-year OS).
5. Implementing standardised lap right hemicolectomy (after learning curve without proctoring)

   1. Consecutive inclusion of patients (n=310)
   2. CT imaging
   3. Video analysis
   4. Competency analysis
   5. Variation analysis
   6. Clinico pathological data

A prospective interventional sequential cohort study with a transition period

Standardizing Right Hemicolectomy for Colon Cancer

Implementation of Optimized and Standardized Surgical Technique for Right Sided Colon Cancer: a Prospective Interventional Sequential Cohort Study With a Transition Period

Assessment according to a competency assessment tool (CAT) for laparoscopic right hemicolectomy. This tool will be created during phase 2 using the Delphi method.

Radicality of resection margin of the specimen, as assessed by the pathologist.

Prof. dr. P.J. Tanis, colorectal surgeon

Dr. B.R. Toorenvliet, colorectal surgeon

D. Miskovic, St Marks hospital London, UK

S. Benz, Klinikverbund SuedWest, Böblingen, Germany

F. Aigner, Krankenhaus der Barmherzigen Bruder, Graz, Austria

C.A. Bertelsen, Hillerød University Hospital, Copenhagen, Denmark

Drs. A.A.J. Grüter

Dr. U.K. Coblijn

Dr. H.L. van Westreenen

Dr. C. Sietses

Prof. dr. E.C.J. Consten

Dr. A.W.H. van de Ven

Dr. P. van Duijvendijk

Dr. S. van Aalten

Dr. F. den Boer

Dr. J.W.A. Leijtens

Dr. C. Hoff

Dr. O. van Ruler

Dr. G. D. Slooter

Prof. dr. J. Lange

Prof. dr. G.J. Kleinrensink

Amsterdam UMC, location VUmc

Symptoms and General Pathology

Adenoma

Polyps

Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section (fully minimally invasive right hemicolectomy)

Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline (standard of care)

Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi.

Robotic right hemicolectomy

Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.

Laparoscopic right hemicolectomy

Jeremy Meyer, MD, MD-PhD

Christian Toso, MD, PhD

Robotic right hemicolectomy with intra-corporeal anastomosis may have better short-term recovery outcomes and decreased incidence of incisional hernia when compared to the laparoscopic actual standard of care, for similar safety outcomes.

During laparoscopic right hemicolectomy (lapRHC) for cancer or polyp, intra-corporeal anastomosis (ICA) offers better short-term recovery and decreased incidence of incisional hernia (IH) when compared to extra-corporeal anastomosis (ECA). However, because of the technical limitations of laparoscopy, ICA has not gained in wide acceptance and ECA has remained the standard of care. On the contrary, robotics offers improved suturing capacities and facilitates the realization of ICA. Therefore, robotic right hemicolectomy (robRHC) with ICA may have better short-term recovery outcomes and decreased incidence of IH when compared to the laparoscopic actual standard of care. In a randomized controlled trial, we will compare robRHC with ICA with lapRHC with ECA, in terms of recovery of bowel function (time to first passage of faeces). Secondary outcomes will notably include length of stay, incidence of IH, patient-reported esthetical outcomes and safety outcomes (morbidity, mortality, proximal and distal margins, harvested lymph nodes).

Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy

Robotic Right Hemicolectomy With Intracorporeal Anastomosis Versus Laparoscopic Right Hemicolectomy With Extracorporeal Anastomosis (PRORHEM): a Randomized Controlled Trial

Measured in hours, starting at the skin closure of the index surgery

Number of patients who received blood and/or blood products transfusion

Number of patients who experienced a complication during the index surgery

Number of patients who had conversion to open surgery; defined as an extraction site longer than 10cm

Number of patients who received a stoma during the index surgery

Number of patients who experienced a post-operative ileus which required the insertion of a nasogastric tube

Number of patients who experienced post-operative morbidity, as measured by the Clavien-Dindo scale

Number of patients who experienced surgical site infection

Number of patients who experienced anastomotic leak, with radiological and/or surgical confirmation

Number of patients who required a surgical re-intervention associated with the index surgery

Number of patients who experienced mortality

Measured in centimeters, on the operative specimen of the index surgery

Number of harvested lymph nodes, on the operative specimen of the index surgery

Type of cancer and/or polyp, based on the operative specimen of the index surgery

8th edition of the UICC TNM classification, based on the operative specimen of the index

Gastrointestinal Quality of Life Index (GQLI)

Measuring the patient-reported esthetical aspect of the surgical wounds

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon	NCT04479111	Hepatic Flexure... Proximal Transv...	laparoscopic il...	18 Years - 75 Years	Zhejiang University
A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach	NCT02949440	Ascending Colon... Ileocaecal Valv... Cancer Flexure ... Adenocarcinoma ...	the caudal-to-c... the medial-to-l...	18 Years - 80 Years	Guangdong Provincial Hospital of Traditional Chinese Medicine
Laparoscopic IIeocecus-Sparing Right Hemicolectomy for Cancer of the Hepatic Flexure and Proximal Transverse Colon	NCT04479111	Hepatic Flexure... Proximal Transv...	laparoscopic il...	18 Years - 75 Years	Zhejiang University
A Study of Laparoscopic Right Hemicolectomy Using the Caudal-to-cranial Approach	NCT02949440	Ascending Colon... Ileocaecal Valv... Cancer Flexure ... Adenocarcinoma ...	the caudal-to-c... the medial-to-l...	18 Years - 80 Years	Guangdong Provincial Hospital of Traditional Chinese Medicine
INtracorporeal Versus EXTracorpoREal anastoMOsis After Laparoscopic Right Colectomy for Cancer	NCT01679756	Colorectal Canc...	Laparoscopic ri...	18 Years - 80 Years	Ospedale Misericordia e Dolce
Study of the Intracorporeal Versus Extracorporeal Anastomosis in Right Hemicolectomy: HEMI-D-TREND-study	NCT03918369	Colon Cancer	Laparoscopic ri... Laparoscopic ri...	18 Years -	Corporacion Parc Tauli
Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer	NCT05039762	Colon Cancer	Extracorporeal ... Intracorporeal ...	18 Years -	University of Southern Denmark
Standardizing Right Hemicolectomy for Colon Cancer	NCT04889456	Colonic Carcino... Laparoscopic Ri... Standardisation Training Delphi Study Implementation Consolidation Assessment	Implementation ... Implementation ...	18 Years -	Amsterdam UMC, location VUmc
Intracorporeal vs. Extracorporeal Anastomosis in Patients Undergoing Laparoscopic Right Hemicolectomy for Colonic Cancer	NCT05039762	Colon Cancer	Extracorporeal ... Intracorporeal ...	18 Years -	University of Southern Denmark
Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy	NCT06067620	Colorectal Neop... Colorectal Neop... Colorectal Neop... Colorectal Canc... Colorectal Poly... Colorectal Aden... Colorectal Aden...	Robotic right h... Laparoscopic ri...	18 Years -	University Hospital, Geneva

Spots Global Cancer Trial Database for laparoscopic right hemicolectomy