Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy (PRORHEM)

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Colorectal Neoplasms; Colorectal Cancer; Colorectal Adenoma; Colorectal Adenocarcinoma; Colorectal Polyp; Colorectal Neoplasms Malignant; Colorectal Neoplasms, Benign
• Intervention / Treatment: Procedure: Robotic right hemicolectomy; Procedure: Laparoscopic right hemicolectomy

Detailed Description

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).

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jeremy Meyer, MD, MD-PhD; Phone Number: +41795533248; Email: jeremy.meyer@hcuge.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients requiring elective minimally invasive RHC for polyps not amenable to endoscopic resection or for cTis-T3 Nx M0 cancer of the right colon (including cancer of the appendix, caecum, ascending colon and hepatic flexure).

Exclusion Criteria:

• Not scheduled for minimally invasive RHC (refuses surgery and/or planned open approach)
• Emergency surgery
• Hereditary colorectal cancer
• Inflammatory bowel disease
• Synchronous resection of (an)other organ(s)
• Synchronous surgical procedure (including more extended resection of the lower gastrointestinal tract)
• cT4
• cM+
• History of laparotomy
• Pregnancy
• No anastomosis planned
• Unable to provide informed consent
• No informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Robotic right hemicolectomy; Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section (fully minimally invasive right hemicolectomy)	Procedure: Robotic right hemicolectomy; Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi.
Active Comparator: Laparoscopic right hemicolectomy; Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline (standard of care)	Procedure: Laparoscopic right hemicolectomy; Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first passage of faeces	Measured in hours, starting at the skin closure of the index surgery	From index surgical procedure (skin closure) until time of first passage of faeces, during hospitalisation, on average during the first 7 post-operative days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgery	Measured in minutes	From skin incision to skin closure, during index surgical procedure
Blood loss	Measured in ml	From skin incision to skin closure, during index surgical procedure
Intra-operative transfusion	Number of patients who received blood and/or blood products transfusion	From skin incision to skin closure, during index surgical procedure
Intra-operative complication	Number of patients who experienced a complication during the index surgery	From skin incision to skin closure, during index surgical procedure
Conversion to open surgery	Number of patients who had conversion to open surgery; defined as an extraction site longer than 10cm	From skin incision to skin closure, during index surgical procedure
Length of the extraction site	Measured in centimeters	At post-operative day 30
Creation of a stoma	Number of patients who received a stoma during the index surgery	From skin incision to skin closure, during index surgical procedure
Hb, WBC and CRP	Blood tests	At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5
Time to first passage of flatus	Measured in hours, starting at the skin closure of the index surgery	From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days
In-hospital postoperative ileus	Number of patients who experienced a post-operative ileus which required the insertion of a nasogastric tube	During hospitalisation, on average during the first 5 post-operative days
Length of stay	Measured in days	From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days
Post-operative morbidity	Number of patients who experienced post-operative morbidity, as measured by the Clavien-Dindo scale	From index surgical procedure (skin closure) to post-operative day 30
Surgical site infection	Number of patients who experienced surgical site infection	From index surgical procedure (skin closure) to post-operative day 7 and post-operative day 30
Anastomotic leak	Number of patients who experienced anastomotic leak, with radiological and/or surgical confirmation	From index surgical procedure (skin closure) to post-operative day 30
Re-intervention	Number of patients who required a surgical re-intervention associated with the index surgery	From index surgical procedure (skin closure) to post-operative day 30
Mortality	Number of patients who experienced mortality	From index surgical procedure (skin closure) to post-operative day 30
Proximal margin	Measured in centimeters, on the operative specimen of the index surgery	Within 10 days from the index surgical procedure
Distal margin	Measured in centimeters, on the operative specimen of the index surgery	Within 10 days from the index surgical procedure
Harvested lymph nodes	Number of harvested lymph nodes, on the operative specimen of the index surgery	Within 10 days from the index surgical procedure
Histology of the tumor/polyp	Type of cancer and/or polyp, based on the operative specimen of the index surgery	Within 10 days from the index surgical procedure
TNM stage	8th edition of the UICC TNM classification, based on the operative specimen of the index	Within 10 days from the index surgical procedure
Bowel function	Gastrointestinal Quality of Life Index (GQLI)	At post-operative day 30 and post-operative year 1
Quality of recovery	Quality of Recovery-15 (QoR-15) score	At post-operative hour 12, post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4, post-operative day 5 and post-operative day 7
Aesthetic numeric analogue scale (ANA-scale)	Measuring the patient-reported esthetical aspect of the surgical wounds	At post-operative day 30 and post-operative year 1
Incidence of incisional hernia	Overall, and at extraction site; measured clinically and by CT	At post-operative year 1

Collaborators and Investigators

• Sponsor: Jeremy Meyer
• Collaborators: University Hospital, Geneva; Hôpital Fribourgeois; Spital Biel, Switzerland
• Investigators: Study Chair: Christian Toso, MD, PhD, University Hospitals of Geneva

Study record dates

Study Major Dates

• Study Start (Estimated): January 1, 2024
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: September 11, 2023
• First Submitted That Met QC Criteria: October 2, 2023
• First Posted (Actual): October 5, 2023

Study Record Updates

• Last Update Posted (Actual): October 5, 2023
• Last Update Submitted That Met QC Criteria: October 2, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Neoplasms; Colorectal Neoplasms; Adenoma
• Other Study ID Numbers: PRORHEM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No