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Completed

NCT Number: NCT03967067

Risk Factors for Major Complications After Liver Resection

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

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Key information

Conditions

Liver Diseases Digestive System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ibn Sina Hospital, Surgical department A

Rabat, 10100, Morocco

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

liver resection

Procedure

Open or laparoscopic, major or minor hepatectomy performed using the clamp-crush technique and intermittent clamping of hepatic pedicle

Primary outcomes

  1. 90-day Mortality rate

    Time frame: 90 days from surgery

    Death within 90 days of surgical procedure

  2. 90-day Complication rate

    Time frame: 90 days from surgery

    Defined by Clavien-Dindo grade I to IV within90 days of surgical procedure

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Moroccan Society of Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2016
Study completion
2016
First posted
May 30, 2019
Registry last updated
May 30, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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