The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis

Study Overview
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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.

Official Title
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The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis

Conditions
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Colon Cancer

Intervention / Treatment
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* Procedure: intracorporeal anastomosis


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The time of activation of patients | We will estimate time to verticalization of patients. | 0 to 10 days | 
| 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 | 
| The time to discharge from hospital | We will count days of postoperativa hospital stay. | 0 to 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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right colon cancer, laparoscopic right colectomy, intracorporeal anastomosis