Risk Factors for Major Complications After Liver Resection

May 26, 2019 updated by: Moroccan Society of Surgery

Risk Factors for Major Complications After Liver Resection: Audit of a Non-Eastern/Non-Western Experience

The aim of this study is to determine the risk factors for major complications following liver resection in the setting of a general surgery-teaching department in Morocco, North Africa

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Over the past 20 years, the refinement of liver surgery techniques, anesthesiology and perioperative management has dramatically improved the safety of liver resection patients. It has also led to a concomitant extension of indications for a growing number of patients with complex benign or malignant hepatobiliary diseases and/or high risk surgeries.

Published complication rates and risk prediction models and recommendations for patients undergoing liver resection primarily stem from far East or Western high-volume specialized centers. In developing countries, including those in North Africa, specific constraints (e.g., endemic indications, such as liver cystic hydatidosis, blood shortage, and the scarcity of liver surgeons and intensive care providers) may impact liver resection outcomes but they are rarely addressed in the literature.

The aim of this study was to determine the risk factors for major complications following liver resection in the setting of a general surgery-teaching department in Morocco, North Africa

Study Type

Observational

Enrollment (Actual)

213

Contacts and Locations

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

Study Locations

  • Morocco
      • Rabat, Morocco, 10100
        • Ibn Sina Hospital, Surgical department A

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

All patient who underwent a liver resection in a sugical hepatobiliary department and who had underwent preoperative serum tests, imaging workup and multidisciplinary discussion, according to the indication for LR. Adequate imaging assessment included the calculation of the future remnant liver volume (RLV) using free software, as needed. Preoperative portal embolization or a 2-step approach, including ALPPS, was considered in non-cirrhotic cases with a RLV to body weight ratio <0.5%

Description

Inclusion Criteria:

  • all patients who underwent an hepatectomy
  • between january 2010 and December 2015

Exclusion Criteria:

  • All patient who only underwent liver biopsy with no resection
  • Patients non operated

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
90-day Mortality rate
Time Frame: 90 days from surgery
Death within 90 days of surgical procedure
90 days from surgery
90-day Complication rate
Time Frame: 90 days from surgery
Defined by Clavien-Dindo grade I to IV within90 days of surgical procedure
90 days from surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Risk factor of major complication at 90-day
Time Frame: 90 days from surgery
defined by multivariate logistic regression of 90 day complication with Clavien-Dindo more than grade III
90 days from surgery

Collaborators and Investigators

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

Sponsor

Moroccan Society of Surgery

Investigators

  • Study Director: Abdelkader Belkouchi, MD, Surgical department A Ibn Sina

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

January 1, 2010

Primary Completion (Actual)

March 31, 2016

Study Completion (Actual)

December 31, 2016

Study Registration Dates

First Submitted

May 26, 2019

First Submitted That Met QC Criteria

May 26, 2019

First Posted (Actual)

May 30, 2019

Study Record Updates

Last Update Posted (Actual)

May 30, 2019

Last Update Submitted That Met QC Criteria

May 26, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LiverResection

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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