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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04578405
Other study ID # JagiellonianU-6
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 1, 2016
Est. completion date July 1, 2020

Study information

Verified date October 2020
Source Jagiellonian University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Both extracorporeal and intracorporeal anastomosis in laparoscopic right hemicolectomy are renowned and performed worldwide. Many observational studies show conflicting results which method is better. This randomized control trial aimed to assess which technique is superior.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date July 1, 2020
Est. primary completion date April 1, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- malignant or benign neoplasm located in right side of the colon

Exclusion Criteria:

- stage IV disease

- conversion

- inflammatory bowel diseases

- corticosteroid intake

- immunodeficiency

- emergency surgery

- neoadjuvant therapy

- no technical possibility to perform either anastomosis

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Intracorporeal anastomosis
Anastomosis performed totally laparoscopically
Extracorporeal anastomosis
Anastomosis performed through a minilaparotomy

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Jagiellonian University

Outcome

Type Measure Description Time frame Safety issue
Primary Time to first stool 5 days
Secondary Time to first flatus 5 days
Secondary Complications 30 day
Secondary Length of surgery 1 day
Secondary Length of hospital stay 30 day
See also
  Status Clinical Trial Phase
Recruiting NCT04628182 - The China Laparoscopic Right Hemicolectomy SNAPSHOT