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Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy

Not Applicable
Not yet recruiting
Conditions
Colorectal Neoplasms Malignant
Colorectal Neoplasms, Benign
Colorectal Polyp
Colorectal Adenocarcinoma
Colorectal Neoplasms
Colorectal Cancer
Colorectal Adenoma
Registration Number
NCT06067620
Lead Sponsor
Jeremy Meyer
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).

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
70
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

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Time to first passage of faecesFrom 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 Outcome Measures
NameTimeMethod
Distal marginWithin 10 days from the index surgical procedure

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

Quality of recoveryAt 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

Blood lossFrom skin incision to skin closure, during index surgical procedure

Measured in ml

Duration of surgeryFrom skin incision to skin closure, during index surgical procedure

Measured in minutes

Intra-operative transfusionFrom skin incision to skin closure, during index surgical procedure

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

Intra-operative complicationFrom skin incision to skin closure, during index surgical procedure

Number of patients who experienced a complication during the index surgery

Creation of a stomaFrom skin incision to skin closure, during index surgical procedure

Number of patients who received a stoma during the index surgery

Post-operative morbidityFrom 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

Re-interventionFrom index surgical procedure (skin closure) to post-operative day 30

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

Length of the extraction siteAt post-operative day 30

Measured in centimeters

Surgical site infectionFrom index surgical procedure (skin closure) to post-operative day 7 and post-operative day 30

Number of patients who experienced surgical site infection

MortalityFrom index surgical procedure (skin closure) to post-operative day 30

Number of patients who experienced mortality

Proximal marginWithin 10 days from the index surgical procedure

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

Harvested lymph nodesWithin 10 days from the index surgical procedure

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

Conversion to open surgeryFrom 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

Hb, WBC and CRPAt post-operative day 1, post-operative day 2, post-operative day 3, post-operative day 4 and post-operative day 5

Blood tests

Time to first passage of flatusFrom 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

In-hospital postoperative ileusDuring 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

Length of stayFrom the first day of hospitalisation to the day of discharge, on average during the first 10 post-operative days

Measured in days

Anastomotic leakFrom index surgical procedure (skin closure) to post-operative day 30

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

Histology of the tumor/polypWithin 10 days from the index surgical procedure

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

TNM stageWithin 10 days from the index surgical procedure

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

Bowel functionAt post-operative day 30 and post-operative year 1

Gastrointestinal Quality of Life Index (GQLI)

Aesthetic numeric analogue scale (ANA-scale)At post-operative day 30 and post-operative year 1

Measuring the patient-reported esthetical aspect of the surgical wounds

Incidence of incisional herniaAt post-operative year 1

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

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