Clinical trial NCT06067620: Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy
Official title: Robotic Right Hemicolectomy With Intracorporeal Anastomosis Versus Laparoscopic Right Hemicolectomy With Extracorporeal Anastomosis (PRORHEM): a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Colorectal Neoplasms
Colorectal Neoplasms Malignant
Colorectal Neoplasms, Benign
Colorectal Cancer
Colorectal Polyp
Colorectal Adenoma
Colorectal Adenocarcinoma
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: University Hospital, Geneva
name: Spital Biel, Switzerland
name: Hôpital Fribourgeois
First posted: 2023-10-05
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Time to first passage of faeces
timeFrame: 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:
measure: Duration of surgery
timeFrame: From skin incision to skin closure, during index surgical procedure
measure: Blood loss
timeFrame: From skin incision to skin closure, during index surgical procedure
measure: Intra-operative transfusion
timeFrame: From skin incision to skin closure, during index surgical procedure
measure: Intra-operative complication
timeFrame: From skin incision to skin closure, during index surgical procedure
measure: Conversion to open surgery
timeFrame: From skin incision to skin closure, during index surgical procedure
measure: Length of the extraction site
timeFrame: At post-operative day 30
measure: Creation of a stoma
timeFrame: From skin incision to skin closure, during index surgical procedure
measure: Hb, WBC and CRP
timeFrame: At post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5
measure: Time to first passage of flatus
timeFrame: From index surgical procedure (skin closure) until time of first passage of flatus, during hospitalisation, on average during the first 7 post-operative days
measure: In-hospital postoperative ileus
timeFrame: During hospitalisation, on average during the first 5 post-operative days
measure: Length of stay
timeFrame: From the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days
measure: Post-operative morbidity
timeFrame: From index surgical procedure (skin closure) to post-operative day 30
measure: Surgical site infection
timeFrame: From index surgical procedure (skin closure) to post-operative day 7 and post-operative day 30
measure: Anastomotic leak
timeFrame: From index surgical procedure (skin closure) to post-operative day 30
measure: Re-intervention
timeFrame: From index surgical procedure (skin closure) to post-operative day 30
measure: Mortality
timeFrame: From index surgical procedure (skin closure) to post-operative day 30
measure: Proximal margin
timeFrame: Within 10 days from the index surgical procedure
measure: Distal margin
timeFrame: Within 10 days from the index surgical procedure
measure: Harvested lymph nodes
timeFrame: Within 10 days from the index surgical procedure
measure: Histology of the tumor/polyp
timeFrame: Within 10 days from the index surgical procedure
measure: TNM stage
timeFrame: Within 10 days from the index surgical procedure
measure: Bowel function
timeFrame: At post-operative day 30 and post-operative year 1
measure: Quality of recovery
timeFrame: 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
measure: Aesthetic numeric analogue scale (ANA-scale)
timeFrame: At post-operative day 30 and post-operative year 1
measure: Incidence of incisional hernia
timeFrame: At post-operative year 1
Other outcomes:
Locations:
Study officials:
affiliation: University Hospitals of Geneva
name: Christian Toso, MD, PhD
role: STUDY_CHAIR
References: