NCT06067620

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.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started Aug 2024

Typical duration for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress73%
Aug 2024Dec 2026

First Submitted

Initial submission to the registry

September 11, 2023

Completed
24 days until next milestone

First Posted

Study publicly available on registry

October 5, 2023

Completed
10 months until next milestone

Study Start

First participant enrolled

August 1, 2024

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

September 11, 2023

Last Update Submit

May 9, 2024

Conditions

Colorectal NeoplasmsColorectal Neoplasms MalignantColorectal Neoplasms, BenignColorectal CancerColorectal PolypColorectal AdenomaColorectal Adenocarcinoma

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (25)

  • Duration of surgery

    From skin incision to skin closure, during index surgical procedure

  • Blood loss

    From skin incision to skin closure, during index surgical procedure

  • Intra-operative transfusion

    From skin incision to skin closure, during index surgical procedure

  • Intra-operative complication

    From skin incision to skin closure, during index surgical procedure

  • Conversion to open surgery

    From skin incision to skin closure, during index surgical procedure

  • +20 more secondary outcomes

Study Arms (2)

Robotic right hemicolectomy

EXPERIMENTAL

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

Procedure: Robotic right hemicolectomy

Laparoscopic right hemicolectomy

ACTIVE COMPARATOR

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

Procedure: Laparoscopic right hemicolectomy

Interventions

Robotic right hemicolectomyPROCEDURE

Robotic right hemicolectomy with intracorporeal anastomosis and extraction through a C-section, using the Da Vinci Xi.

Robotic right hemicolectomy
Laparoscopic right hemicolectomyPROCEDURE

Laparoscopic right hemicolectomy with extracorporeal anastomosis and extraction through midline.

Laparoscopic right hemicolectomy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Colorectal NeoplasmsColonic Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Christian Toso, MD, PhD

    University Hospitals of Geneva

    STUDY CHAIR

Central Study Contacts

Jeremy Meyer, MD, MD-PhD

CONTACT

+41795533248jeremy.meyer@hcuge.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 11, 2023

First Posted

October 5, 2023

Study Start

August 1, 2024

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share