NCT03130166

Brief Summary

Right-sided colonic cancer is treated with right-sided colectomy, predominantly performed as minimally invasive surgery with extracorporeal anastomosis (ECA). In recent years a new technique with intracorporeal anastomosis (ICA) has emerged and it is thought that ICA is less invasive and thereby has the potential to improve the postoperative course of right colonic cancer patients. The objective of this study is to compare robotic right colectomy with either ICA or ECA in a randomized controlled setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 26, 2017

Completed
1 year until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2020

Completed
Last Updated

January 5, 2021

Status Verified

January 1, 2021

Enrollment Period

2.7 years

First QC Date

April 23, 2017

Last Update Submit

January 3, 2021

Conditions

Colonic Cancer

Keywords

Postoperative painPostoperative recoveryIntracorporeal anastomosisRobotic right colectomy

Outcome Measures

Primary Outcomes (1)

  • Postoperative recovery

    Questionnaire of Recovery 15 (QoR-15)

    1 month

Secondary Outcomes (12)

  • Time fo first flatus

    1 month

  • Time to first bowel movement

    1 month

  • Length of hospital stay

    1 month

  • Morbidity

    1 month

  • Mortality

    1 month

  • +7 more secondary outcomes

Study Arms (2)

Intracorporeal anastomosis

EXPERIMENTAL

Patients undergo robotic right colectomy with intracorporeal anastomosis.

Procedure: Intracorporeal anastomosis

Extracorporeal anastomosis

ACTIVE COMPARATOR

Patients undergo robotic right colectomy with extracorporeal anastomosis.

Procedure: Extracorporeal anastomosis

Interventions

Intracorporeal anastomosisPROCEDURE

Use of intracorporeal anastomosis technique

Intracorporeal anastomosis
Extracorporeal anastomosisPROCEDURE

Use of the conventional extracorporeal anastomosis technique

Extracorporeal anastomosis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Herlev Hospital

Herlev, Copenhagen, Denmark

Location

Sealand University Hospital

Roskilde, Denmark

Location

Related Publications (3)

  • Dohrn N, Oppermann C, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. The effect of intracorporeal versus extracorporeal anastomosis in robotic right colectomy on perianastomotic perfusion: a substudy to a multicenter RCT. Langenbecks Arch Surg. 2022 Dec;407(8):3577-3586. doi: 10.1007/s00423-022-02693-4. Epub 2022 Sep 28.

    PMID: 36171282DERIVED

  • Dohrn N, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Sorensen F, Jakobsen HL, Brisling S, Lykke J, Eriksen JR, Klein MF, Gogenur I. Intracorporeal Versus Extracorporeal Anastomosis in Robotic Right Colectomy: A Multicenter, Triple-blind, Randomized Clinical Trial. Ann Surg. 2022 Nov 1;276(5):e294-e301. doi: 10.1097/SLA.0000000000005254. Epub 2021 Oct 13.

    PMID: 35129520DERIVED

  • Dohrn N, Klein MF, Gogenur I. Intracorporeal versus extracorporeal anastomosis in right colectomy - a protocol for a randomised trial. Dan Med J. 2021 Apr 20;68(5):A09200710.

    PMID: 33913415DERIVED

MeSH Terms

Conditions

Colonic NeoplasmsPain, Postoperative

Condition Hierarchy (Ancestors)

Colorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD.

Study Record Dates

First Submitted

April 23, 2017

First Posted

April 26, 2017

Study Start

May 1, 2018

Primary Completion

December 29, 2020

Study Completion

December 29, 2020

Last Updated

January 5, 2021

Record last verified: 2021-01

Locations

DK(2)