The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis

Not Applicable

• Conditions: Colon Cancer
• Interventions: Procedure: intracorporeal anastomosis

• Registration Number: NCT05026268
• Lead Sponsor: State Scientific Centre of Coloproctology, Russian Federation

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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-06
• Study First Submitted QC: 2021-08-23
• Last Update Submitted: 2021-08-23
• Study First Posted: 2021-08-30
• Last Update Posted: 2021-08-30
• Study Start: 2021-09
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Post-operative complications rate	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).

Secondary Outcome Measures

Name	Time	Method
The level of postoperative pain	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).
The time of activation of patients	0 to 10 days	We will estimate time to verticalization of patients.
The amount of self-help of patients	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.
The time to discharge from hospital	0 to 30 days	We will count days of postoperativa hospital stay.

Trial Locations

Locations (1)

State Scientific Centre of Coloproctology, Russian Federation; 🇷🇺 Moscow, Russian Federation