Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy

Trial Title: Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy

NCT ID: NCT06067620

Condition: Colorectal Neoplasms
Colorectal Neoplasms Malignant
Colorectal Neoplasms, Benign
Colorectal Cancer
Colorectal Polyp
Colorectal Adenoma
Colorectal Adenocarcinoma

Conditions: Official terms:
Neoplasms
Colorectal Neoplasms
Adenoma

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Double (Participant, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Robotic right hemicolectomy
Description: Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi.
Arm group label: Robotic right hemicolectomy

Intervention type: Procedure
Intervention name: Laparoscopic right hemicolectomy
Description: Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.
Arm group label: Laparoscopic right hemicolectomy

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).

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Start date: August 1, 2024

Completion date: December 31, 2026

Lead sponsor:
Agency: Jeremy Meyer
Agency class: Other

Collaborator:
Agency: University Hospital, Geneva
Agency class: Other

Collaborator:
Agency: Spital Biel, Switzerland
Agency class: Other

Collaborator:
Agency: Hôpital Fribourgeois
Agency class: Other

Source: University Hospital, Geneva

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06067620