Robotic Right Hemicolectomy Versus Laparoscopic Right Hemicolectomy (PRORHEM)

Jeremy Meyer

Status: Not yet enrolling

Conditions: Colorectal Adenocarcinoma; Colorectal Adenoma; Colorectal Polyp; Colorectal Neoplasms Malignant; Colorectal Neoplasms, Benign; Colorectal Neoplasms; Colorectal Cancer

Treatments: Procedure: Robotic right hemicolectomy; Procedure: Laparoscopic right hemicolectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT06067620

PRORHEM

Details and patient eligibility

About

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.

Full 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).

Enrollment: 70 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Robotic right hemicolectomy

Experimental group

Description:

Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section (fully minimally invasive right hemicolectomy)

Treatment:

Procedure: Robotic right hemicolectomy

Laparoscopic right hemicolectomy

Active Comparator group

Description:

Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline (standard of care)

Treatment:

Procedure: Laparoscopic right hemicolectomy