Anastomotic Leakage in Right Colectomy

August 11, 2024 updated by: ILIYAN ILIEV, Barmherzige Brüder Vienna

Open Versus Laparoscopic Right Colectomy: Does the Initial Approach Impact on Management and Outcome in Anastomotic Leakage? A Multicenter Cohort Study

Data of patients undergoing elective right colectomy for benign and malignant disease using an open or laparoscopic approach are to be collected in seven colorectal units among Austria for the period between January 2010 and December 2019. Demographic, peri- and postoperative data of patients were analyzed retrospectively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

3446

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with benign or malignant diseases in the right colon.

Description

Inclusion Criteria:

  • Patients with benign or malignant diseases in the right portion of the colon.
  • elective surgery

Exclusion Criteria:

  • emergent surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients after laparoscopic right hemicolectomy
Patients who had undergone a laparoscopic tight colectomy and had anastomotic leak.
Procedure: suturing of leak, lavage, drainage
Operative suturing of the leak, lavage, drainage within a revision surgery.
Procedure: Formation of a new anasthomosis
Operative resection of the old leaking anastomosis and formation of a new one.
Procedure: Fecal diversion
Formation of a deviating stoma.
Patients after open right hemicolectomy
Patients who had undergone a laparoscopic tight colectomy and had anastomotic leak.
Procedure: suturing of leak, lavage, drainage
Operative suturing of the leak, lavage, drainage within a revision surgery.
Procedure: Formation of a new anasthomosis
Operative resection of the old leaking anastomosis and formation of a new one.
Procedure: Fecal diversion
Formation of a deviating stoma.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical outcome
Time Frame: 2010-2019
Survival or death
2010-2019

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barmherzige Brüder Vienna

Collaborators

Medical University of Vienna
University Hospital, Saarland
Kepler University Hospital
University of Salzburg
Hospital Barmherzige Schwestern Vienna
Sigmund Freud PrivatUniversitat
Barmherzige Brüder Salzburg

Investigators

  • Principal Investigator: Bernhard Dauser, Assoc. Prof., Krankenhaus der Barmherzigen Brüder Vienna

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 12, 2024

Primary Completion (Estimated)

October 12, 2024

Study Completion (Estimated)

December 12, 2024

Study Registration Dates

First Submitted

August 11, 2024

First Submitted That Met QC Criteria

August 11, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 11, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LEAK1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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