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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06067620
Other study ID # PRORHEM
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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