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NCT Number: NCT06067620

Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy

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.

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Key information

Conditions

Colorectal Neoplasms Colonic Diseases Colonic Neoplasms Colorectal Adenocarcinoma Colorectal Adenoma Colorectal Cancer Colorectal Neoplasms Malignant Colorectal Neoplasms, Benign Colorectal Polyp Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site Rectal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotic right hemicolectomy

Procedure

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

laparoscopic right hemicolectomy

Procedure

Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.

Primary outcomes

  1. 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

Secondary outcomes

  1. Duration of surgery

    Time frame: From skin incision to skin closure, during index surgical procedure

    Measured in minutes

  2. Blood loss

    Time frame: From skin incision to skin closure, during index surgical procedure

    Measured in ml

  3. 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

  4. 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

  5. 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

  6. Length of the extraction site

    Time frame: At post-operative day 30

    Measured in centimeters

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. Mortality

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

    Number of patients who experienced mortality

  17. Proximal margin

    Time frame: Within 10 days from the index surgical procedure

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

  18. Distal margin

    Time frame: Within 10 days from the index surgical procedure

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

  19. 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

  20. 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

  21. 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

  22. Bowel function

    Time frame: At post-operative day 30 and post-operative year 1

    Gastrointestinal Quality of Life Index (GQLI)

  23. 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

  24. 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

  25. Incidence of incisional hernia

    Time frame: At post-operative year 1

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jeremy Meyer, MD, MD-PhD

CONTACT

[email protected]

+41795533248

Sponsors and collaborators

Lead sponsor

Jeremy Meyer

Other

Collaborators

  • Hôpital Fribourgeois
  • Spital Biel, Switzerland
  • University Hospital, Geneva

Registry information

Official study title

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

Acronym: PRORHEM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 5, 2023
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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