AzTrials
AzTrials

Colorectal NeoplasmsPRORHEMNCT06067620

Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy

A study testing Robotic right hemicolectomy and Laparoscopic right hemicolectomy in people with Colorectal Neoplasms and Colorectal Neoplasms Malignant, run by Jeremy Meyer.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Robotic right hemicolectomy and Laparoscopic right hemicolectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
1 Aug 2024to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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)
Show all 13Show fewer
  • cT4
  • cM+
  • History of laparotomy
  • Pregnancy
  • No anastomosis planned
  • Unable to provide informed consent
  • No informed consent

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Jeremy Meyer, MD, MD-PhD contact

+41795533248

jeremy.meyer@hcuge.ch

About this study

Official title: 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.

Read the 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).

Being tested
Robotic right hemicolectomy, Laparoscopic right hemicolectomy
Medical subject headings
Colorectal Neoplasms, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Robotic right hemicolectomyProcedure or surgery

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

  • Laparoscopic right hemicolectomyProcedure or surgery

    Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.

Study groups in NCT06067620
Study groupRoleWhat they receive
Robotic right hemicolectomyExperimentalRobotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section (fully minimally invasive right hemicolectomy)
Receives: Procedure: Robotic right hemicolectomy
Laparoscopic right hemicolectomyActive comparatorLaparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline (standard of care)
Receives: Procedure: Laparoscopic right hemicolectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first passage of faeces

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

    Measured: 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 outcomes (25)

  1. Duration of surgery

    Measured in minutes

    Measured: From skin incision to skin closure, during index surgical procedure

  2. Blood loss

    Measured in ml

    Measured: From skin incision to skin closure, during index surgical procedure

  3. Intra-operative transfusion

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

    Measured: From skin incision to skin closure, during index surgical procedure

  4. Intra-operative complication

    Number of patients who experienced a complication during the index surgery

    Measured: From skin incision to skin closure, during index surgical procedure

  5. Conversion to open surgery

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

    Measured: From skin incision to skin closure, during index surgical procedure

  6. Length of the extraction site

    Measured in centimeters

    Measured: At post-operative day 30

  7. Creation of a stoma

    Number of patients who received a stoma during the index surgery

    Measured: From skin incision to skin closure, during index surgical procedure

  8. Hb, WBC and CRP

    Blood tests

    Measured: At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5

  9. Time to first passage of flatus

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

    Measured: From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days

  10. In-hospital postoperative ileus

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

    Measured: During hospitalisation, on average during the first 5 post-operative days

  11. Length of stay

    Measured in days

    Measured: From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days

  12. Post-operative morbidity

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

    Measured: From index surgical procedure (skin closure) to post-operative day 30

  13. Surgical site infection

    Number of patients who experienced surgical site infection

    Measured: From index surgical procedure (skin closure) to post-operative day 7 and post-operative day 30

  14. Anastomotic leak

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

    Measured: From index surgical procedure (skin closure) to post-operative day 30

  15. Re-intervention

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

    Measured: From index surgical procedure (skin closure) to post-operative day 30

  16. Mortality

    Number of patients who experienced mortality

    Measured: From index surgical procedure (skin closure) to post-operative day 30

  17. Proximal margin

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

    Measured: Within 10 days from the index surgical procedure

  18. Distal margin

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

    Measured: Within 10 days from the index surgical procedure

  19. Harvested lymph nodes

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

    Measured: Within 10 days from the index surgical procedure

  20. Histology of the tumor/polyp

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

    Measured: Within 10 days from the index surgical procedure

  21. TNM stage

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

    Measured: Within 10 days from the index surgical procedure

  22. Bowel function

    Gastrointestinal Quality of Life Index (GQLI)

    Measured: At post-operative day 30 and post-operative year 1

  23. Quality of recovery

    Quality of Recovery-15 (QoR-15) score

    Measured: 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

  24. Aesthetic numeric analogue scale (ANA-scale)

    Measuring the patient-reported esthetical aspect of the surgical wounds

    Measured: At post-operative day 30 and post-operative year 1

  25. Incidence of incisional hernia

    Overall, and at extraction site; measured clinically and by CT

    Measured: At post-operative year 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Oct 2023
  2. Study start1 Aug 2024 (estimated)
  3. Primary completion1 Aug 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06067620
Sponsor's protocol ID
PRORHEM
Acronym
PRORHEM
Status last verified
May 2024
First submitted
11 Sep 2023
Last updated
10 May 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Meyer J, Liot E, Meurette G, Toso C, Ris F. Robotic right hemicolectomy with intracorporeal anastomosis versus laparoscopic right hemicolectomy with extracorporeal anastomosis (PRORHEM): protocol for a randomized controlled trial. BMC Surg. 2026 Jul 8. doi: 10.1186/s12893-026-03990-1. Online ahead of print.

    PubMed 42420958

Questions about this trial

What is this clinical trial studying?

A study testing Robotic right hemicolectomy and Laparoscopic right hemicolectomy in people with Colorectal Neoplasms and Colorectal Neoplasms Malignant, run by Jeremy Meyer.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeremy Meyer, MD, MD-PhD (+41795533248, jeremy.meyer@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06067620, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2024.

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