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The Laparoscopic Right Colectomy With Intracoroporeal Anastomosis (LaRCIa)

S

State Scientific Centre of Coloproctology, Russian Federation

Status

Unknown

Conditions

Colon Cancer

Treatments

Procedure: intracorporeal anastomosis

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

2 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

2 participants in 2 patient groups

Intracorporeal anastomosis
Experimental group
Description:
A laparoscopic right colectomy will be performed according to the surgeons standard practice with the intracorporeal anastomosis performing.
Treatment:
Procedure: intracorporeal anastomosis
extracorporeal anastomosis
No Intervention group
Description:
A laparoscopic right colectomy will be performed according to the surgeons standard practice.

Trial contacts and locations

1

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Central trial contact

Sergey Achkasov, MD

Data sourced from clinicaltrials.gov

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