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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05026268
Other study ID # 16/21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2021
Est. completion date August 2023

Study information

Verified date August 2021
Source State Scientific Centre of Coloproctology, Russian Federation
Contact Sergey Achkasov, MD
Phone 89036710225
Email achkasovy@mail.ru
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 2
Est. completion date August 2023
Est. primary completion date August 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Procedure:
intracorporeal anastomosis
intracorporeal stapled "side-to-side" isoperistaltic anastomosis

Locations

Country Name City State
Russian Federation State Scientific Centre of Coloproctology, Russian Federation Moscow

Sponsors (1)

Lead Sponsor Collaborator
State Scientific Centre of Coloproctology, Russian Federation

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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). 0 to 30 days
Secondary 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). 0 to 10 days
Secondary The time of activation of patients We will estimate time to verticalization of patients. 0 to 10 days
Secondary 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. 0 to 10 days
Secondary The time to discharge from hospital We will count days of postoperativa hospital stay. 0 to 30 days
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