Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy

Colorectal Cancer Clinical Trial

— PRORHEM  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06067620
• Other study ID #: PRORHEM
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 1, 2024
• Est. completion date: December 31, 2026

Study information

• Verified date: May 2024
• Source: University Hospital, Geneva
• Contact: Jeremy Meyer, MD, MD-PhD
• Phone: +41795533248
• Email: jeremy.meyer[@]hcuge.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: December 31, 2026
• Est. primary completion date: August 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Adenoma
• Colorectal Adenocarcinoma
• Colorectal Adenoma
• Colorectal Cancer
• Colorectal Neoplasms
• Colorectal Neoplasms Malignant
• Colorectal Neoplasms, Benign
• Colorectal Polyp
• Neoplasms

Intervention

Procedure:
• Robotic right hemicolectomy
Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi.
• Laparoscopic right hemicolectomy
Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
Jeremy Meyer	Hôpital Fribourgeois, Spital Biel, Switzerland, University Hospital, Geneva

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of surgery	Measured in minutes	From skin incision to skin closure, during index surgical procedure
Secondary	Blood loss	Measured in ml	From skin incision to skin closure, during index surgical procedure
Secondary	Intra-operative transfusion	Number of patients who received blood and/or blood products transfusion	From skin incision to skin closure, during index surgical procedure
Secondary	Intra-operative complication	Number of patients who experienced a complication during the index surgery	From skin incision to skin closure, during index surgical procedure
Secondary	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
Secondary	Length of the extraction site	Measured in centimeters	At post-operative day 30
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Mortality	Number of patients who experienced mortality	From index surgical procedure (skin closure) to post-operative day 30
Secondary	Proximal margin	Measured in centimeters, on the operative specimen of the index surgery	Within 10 days from the index surgical procedure
Secondary	Distal margin	Measured in centimeters, on the operative specimen of the index surgery	Within 10 days from the index surgical procedure
Secondary	Harvested lymph nodes	Number of harvested lymph nodes, on the operative specimen of the index surgery	Within 10 days from the index surgical procedure
Secondary	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
Secondary	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
Secondary	Bowel function	Gastrointestinal Quality of Life Index (GQLI)	At post-operative day 30 and post-operative year 1
Secondary	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
Secondary	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
Secondary	Incidence of incisional hernia	Overall, and at extraction site; measured clinically and by CT	At post-operative year 1