NCT03967067

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 30, 2019

Completed
Last Updated

May 30, 2019

Status Verified

May 1, 2019

Enrollment Period

6.2 years

First QC Date

May 26, 2019

Last Update Submit

May 26, 2019

Conditions

Liver Diseases

Keywords

AuditLiver resectionSurgical complicationsnon-Eastern/non-WesternQuality improvement

Outcome Measures

Primary Outcomes (2)

  • 90-day Mortality rate

    Death within 90 days of surgical procedure

    90 days from surgery

  • 90-day Complication rate

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

    90 days from surgery

Secondary Outcomes (1)

  • Risk factor of major complication at 90-day

    90 days from surgery

Interventions

liver resectionPROCEDURE

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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%

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ibn Sina Hospital, Surgical department A

Rabat, 10100, Morocco

Location

Related Publications (5)

  • Dokmak S, Fteriche FS, Borscheid R, Cauchy F, Farges O, Belghiti J. 2012 Liver resections in the 21st century: we are far from zero mortality. HPB (Oxford). 2013 Nov;15(11):908-15. doi: 10.1111/hpb.12069. Epub 2013 Mar 6.

    PMID: 23461811BACKGROUND

  • Lim C, Dejong CH, Farges O; e-HPBchir Study Group from the Association de Chirurgie Hepato-Biliaire et de Transplantation (ACHBT) (Association of Hepatobilary and Transplant Surgery). Improving the quality of liver resection: a systematic review and critical analysis of the available prognostic models. HPB (Oxford). 2015 Mar;17(3):209-21. doi: 10.1111/hpb.12346. Epub 2014 Oct 17.

    PMID: 25322917BACKGROUND

  • Benkabbou A, Souadka A, Serji B, Hachim H, Mohsine R, Ifrine L, Belkouchi A, El Malki HO. Changing paradigms in the surgical management of cystic liver hydatidosis improve the postoperative outcomes. Surgery. 2016 Apr;159(4):1170-80. doi: 10.1016/j.surg.2015.10.029. Epub 2015 Dec 31.

    PMID: 26747223BACKGROUND

  • Galun DA, Bulajic P, Zuvela M, Basaric D, Ille T, Milicevic MN. Is there any benefit from expanding the criteria for the resection of hepatocellular carcinoma in cirrhotic liver? Experience from a developing country. World J Surg. 2012 Jul;36(7):1657-65. doi: 10.1007/s00268-012-1544-x.

    PMID: 22395347BACKGROUND

  • Mann CD, Palser T, Briggs CD, Cameron I, Rees M, Buckles J, Berry DP. A review of factors predicting perioperative death and early outcome in hepatopancreaticobiliary cancer surgery. HPB (Oxford). 2010 Aug;12(6):380-8. doi: 10.1111/j.1477-2574.2010.00179.x.

    PMID: 20662788BACKGROUND

MeSH Terms

Conditions

Liver Diseases

Interventions

Hepatectomy

Condition Hierarchy (Ancestors)

Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Abdelkader Belkouchi, MD

    Surgical department A Ibn Sina

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2019

First Posted

May 30, 2019

Study Start

January 1, 2010

Primary Completion

March 31, 2016

Study Completion

December 31, 2016

Last Updated

May 30, 2019

Record last verified: 2019-05

Locations

MO(1)