Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy (PRORHEM)

May 9, 2024 updated by: Jeremy Meyer

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Adult patients requiring elective minimally invasive RHC for cT1-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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to first passage of faeces
Time Frame: From index surgical procedure (skin closure) until time of first passage of faeces, during hospitalisation, on average during the first 7 post-operative days
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Duration of surgery
Time Frame: From skin incision to skin closure, during index surgical procedure
Measured in minutes
From skin incision to skin closure, during index surgical procedure
Blood loss
Time Frame: From skin incision to skin closure, during index surgical procedure
Measured in ml
From skin incision to skin closure, during index surgical procedure
Intra-operative transfusion
Time Frame: From skin incision to skin closure, during index surgical procedure
Number of patients who received blood and/or blood products transfusion
From skin incision to skin closure, during index surgical procedure
Intra-operative complication
Time Frame: From skin incision to skin closure, during index surgical procedure
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
Time Frame: From skin incision to skin closure, during index surgical procedure
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
Time Frame: At post-operative day 30
Measured in centimeters
At post-operative day 30
Creation of a stoma
Time Frame: From skin incision to skin closure, during index surgical procedure
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
Time Frame: At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5
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
Time Frame: From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days
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
Time Frame: During hospitalisation, on average during the first 5 post-operative days
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
Time Frame: From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days
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
Time Frame: From index surgical procedure (skin closure) to post-operative day 30
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
Time Frame: From index surgical procedure (skin closure) to post-operative day 7 and post-operative day 30
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
Time Frame: From index surgical procedure (skin closure) to post-operative day 30
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
Time Frame: From index surgical procedure (skin closure) to post-operative day 30
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
Time Frame: From index surgical procedure (skin closure) to post-operative day 30
Number of patients who experienced mortality
From index surgical procedure (skin closure) to post-operative day 30
Proximal margin
Time Frame: Within 10 days from the index surgical procedure
Measured in centimeters, on the operative specimen of the index surgery
Within 10 days from the index surgical procedure
Distal margin
Time Frame: Within 10 days from the index surgical procedure
Measured in centimeters, on the operative specimen of the index surgery
Within 10 days from the index surgical procedure
Harvested lymph nodes
Time Frame: Within 10 days from the index surgical procedure
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
Time Frame: Within 10 days from the index surgical procedure
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
Time Frame: Within 10 days from the index surgical procedure
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
Time Frame: At post-operative day 30 and post-operative year 1
Gastrointestinal Quality of Life Index (GQLI)
At post-operative day 30 and post-operative year 1
Quality of recovery
Time Frame: 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
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)
Time Frame: At post-operative day 30 and post-operative year 1
Measuring the patient-reported esthetical aspect of the surgical wounds
At post-operative day 30 and post-operative year 1
Incidence of incisional hernia
Time Frame: At post-operative year 1
Overall, and at extraction site; measured clinically and by CT
At post-operative year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jeremy Meyer

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Hospital, Geneva
Hôpital Fribourgeois
Spital Biel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Christian Toso, MD, PhD, University Hospitals of Geneva

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 11, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 2, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 5, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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