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The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis (LaRCIa)

Primary Purpose

Colon Cancer

Status
Unknown status
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
intracorporeal anastomosis
Sponsored by
State Scientific Centre of Coloproctology, Russian Federation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Colon Cancer focused on measuring right colon cancer, laparoscopic right colectomy, intracorporeal anastomosis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • State Scientific Centre of Coloproctology, Russian FederationRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intracorporeal anastomosis

extracorporeal anastomosis

Arm Description

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

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

Outcomes

Primary Outcome Measures

Post-operative complications rate
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).

Secondary Outcome Measures

The level of postoperative pain
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).
The time of activation of patients
We will estimate time to verticalization of patients.
The amount of self-help of patients
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.
The time to discharge from hospital
We will count days of postoperativa hospital stay.

Full Information

First Posted
August 6, 2021
Last Updated
August 23, 2021
Sponsor
State Scientific Centre of Coloproctology, Russian Federation
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1. Study Identification

Unique Protocol Identification Number
NCT05026268
Brief Title
The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
Acronym
LaRCIa
Official Title
The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 2021 (Anticipated)
Primary Completion Date
August 2023 (Anticipated)
Study Completion Date
August 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
State Scientific Centre of Coloproctology, Russian Federation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colon Cancer
Keywords
right colon cancer, laparoscopic right colectomy, intracorporeal anastomosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intracorporeal anastomosis
Arm Type
Experimental
Arm Description
A laparoscopic right colectomy will be performed according to the surgeons standard practice with the intracorporeal anastomosis performing.
Arm Title
extracorporeal anastomosis
Arm Type
No Intervention
Arm Description
A laparoscopic right colectomy will be performed according to the surgeons standard practice.
Intervention Type
Procedure
Intervention Name(s)
intracorporeal anastomosis
Intervention Description
intracorporeal stapled "side-to-side" isoperistaltic anastomosis
Primary Outcome Measure Information:
Title
Post-operative complications rate
Description
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).
Time Frame
0 to 30 days
Secondary Outcome Measure Information:
Title
The level of postoperative pain
Description
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).
Time Frame
0 to 10 days
Title
The time of activation of patients
Description
We will estimate time to verticalization of patients.
Time Frame
0 to 10 days
Title
The amount of self-help of patients
Description
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.
Time Frame
0 to 10 days
Title
The time to discharge from hospital
Description
We will count days of postoperativa hospital stay.
Time Frame
0 to 30 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sergey Achkasov, MD
Phone
89036710225
Email
achkasovy@mail.ru
Facility Information:
Facility Name
State Scientific Centre of Coloproctology, Russian Federation
City
Moscow
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sergey Achkasov, MD

12. IPD Sharing Statement

Learn more about this trial

The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis

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