The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis (LaRCIa)

August 23, 2021 updated by: State Scientific Centre of Coloproctology, Russian Federation
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • State Scientific Centre of Coloproctology, Russian Federation
        • Contact:
          • Sergey Achkasov, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intracorporeal anastomosis
A laparoscopic right colectomy will be performed according to the surgeons standard practice with the intracorporeal anastomosis performing.
Procedure: intracorporeal anastomosis
intracorporeal stapled "side-to-side" isoperistaltic anastomosis
No Intervention: extracorporeal anastomosis
A laparoscopic right colectomy will be performed according to the surgeons standard practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-operative complications rate
Time Frame: 0 to 30 days
The incidence and structure of postoperative complications according to the Clavien-Dindo scale (I-grade - any deviation from the normal course of the postoperative course without the need for pharmacological, surgical, endoscopic or interventional radiological interventions. drugs that are acceptable include antiemetics, antipyretics, analgesics, diuretics, and electrolytes. In addition, this grade includes a wound infection "stopped at the patient's bedside", V grades - Death of the patient).
0 to 30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The level of postoperative pain
Time Frame: 0 to 10 days
The level of postoperative pain with using a visual analogue pain scale: The patient assesses the postoperative pain from 0 to 10 points (0 points - no pain, 10 - unbearable pain).
0 to 10 days
The time of activation of patients
Time Frame: 0 to 10 days
We will estimate time to verticalization of patients.
0 to 10 days
The amount of self-help of patients
Time Frame: 0 to 10 days
We will estimate the amount of self-help of patients on the Bartel scale. Total score - 100. Indicators from 0 to 20 points correspond to complete dependence, from 21 to 60 points - severe dependence, from 61 to 90 points - moderate, from 91 to 99 life points - light dependence in everyday life.
0 to 10 days
The time to discharge from hospital
Time Frame: 0 to 30 days
We will count days of postoperativa hospital stay.
0 to 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

State Scientific Centre of Coloproctology, Russian Federation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 1, 2021

Primary Completion (Anticipated)

August 1, 2023

Study Completion (Anticipated)

August 1, 2023

Study Registration Dates

First Submitted

August 6, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 23, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16/21

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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