INtracorporeal Versus EXtracorporeal Anastomosis in Robotic Right Colectomy

NCT ID: NCT03130166

Last Updated: 2021-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2020-12-29

Brief Summary

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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.

Detailed Description

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Conditions

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Colonic Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intracorporeal anastomosis

Patients undergo robotic right colectomy with intracorporeal anastomosis.

Group Type EXPERIMENTAL

Intracorporeal anastomosis

Intervention Type PROCEDURE

Use of intracorporeal anastomosis technique

Extracorporeal anastomosis

Patients undergo robotic right colectomy with extracorporeal anastomosis.

Group Type ACTIVE_COMPARATOR

Extracorporeal anastomosis

Intervention Type PROCEDURE

Use of the conventional extracorporeal anastomosis technique

Interventions

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Intracorporeal anastomosis

Use of intracorporeal anastomosis technique

Intervention Type PROCEDURE

Extracorporeal anastomosis

Use of the conventional extracorporeal anastomosis technique

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

All patients scheduled for robotic right colectomy due to colonic cancer are eligible for inclusion.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Herlev and Gentofte Hospital

OTHER

Sponsor Role lead

Responsible Party

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Niclas Dohrn

MD.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Herlev Hospital

Herlev, Copenhagen, Denmark

Site Status

Sealand University Hospital

Roskilde, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 36171282 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35129520 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33913415 (View on PubMed)

Other Identifiers

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RCT0001

Identifier Type: -

Identifier Source: org_study_id

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