The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis

NCT ID: NCT05026268

Last Updated: 2021-08-30

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

2 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2023-08-31

Brief Summary

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This is a randomized, controlled, "non-inferiority" trial to determine the non-difference in post-operative complications rate in laparoscopic right colectomy with intracorporeal or extracorporeal anastomosis formation.

Detailed Description

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The design involves random allocation of eligible patients to laparosopic colectomy with intracorporeal or extracorporeal anastomosis.

Postoperative complications in both groups will be recorded in accordance with the Clavien-Dindo classification. The level of postoperative pain will be registred according to the visual analogue pain scale (VAS). Also the investigators will study the time of activation of patients, patient self-care scope according to the Bartell scale, postoperative hospital stay will be assessed.

Conditions

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Colon Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intracorporeal anastomosis

A laparoscopic right colectomy will be performed according to the surgeons standard practice with the intracorporeal anastomosis performing.

Group Type EXPERIMENTAL

intracorporeal anastomosis

Intervention Type PROCEDURE

intracorporeal stapled "side-to-side" isoperistaltic anastomosis

extracorporeal anastomosis

A laparoscopic right colectomy will be performed according to the surgeons standard practice.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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intracorporeal anastomosis

intracorporeal stapled "side-to-side" isoperistaltic anastomosis

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients age is 18 years and older
* Patients with right colon cancer
* Informed agreement

Exclusion Criteria

* Carcinomatosis
* Primary tumor stage T4b
* Refusal of anastomosis
* Refusal of the patient to participate in the study
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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State Scientific Centre of Coloproctology, Russian Federation

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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State Scientific Centre of Coloproctology, Russian Federation

Moscow, , Russia

Site Status RECRUITING

Countries

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Russia

Central Contacts

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Sergey Achkasov, MD

Role: CONTACT

89036710225

Facility Contacts

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Sergey Achkasov, MD

Role: primary

Other Identifiers

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16/21

Identifier Type: -

Identifier Source: org_study_id

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