The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis

Colon Cancer Clinical Trial

— LaRCIa  

Official title:

The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05026268
• Other study ID #: 16/21
• Status: Recruiting
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms

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