NCT02123719

Brief Summary

Retrospective analysis of patients undergoing laparoscopic incisional hernia repair. Study group: Patients with incisional hernia post liver transplantation Control group: Patients with incisional hernia post any other laparotomy in the upper quadrant. Primary study outcome parameter: Risk of hernia recurrence. Secondary study outcome parameters: - Hernia repair-related infection rate \- Postoperative morbidity Statistical analysis: Comparison of study versus control group, univariate and multivariate analysis, Chi² and Mann-Whitney-U tests. P-values \<0.05 were considered significant.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2013

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, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 25, 2014

Completed
Last Updated

April 25, 2014

Status Verified

April 1, 2014

Enrollment Period

11 months

First QC Date

April 24, 2014

Last Update Submit

April 24, 2014

Conditions

Hernia Recurrence Post Laparoscopic Incisional Hernia Repair in Liver Transplant Versus Non-transplant Patients.

Outcome Measures

Primary Outcomes (1)

  • Hernia recurrence post laparoscopic incisional hernia repair

    1 - 74 months post surgery

Study Arms (2)

Patients post liver transplantation

Patients after liver transplantation

Other: Surgery

Control group

Patients with an abdominal incisional hernia without a history of immunosuppresion

Other: Surgery

Interventions

SurgeryOTHER
Control groupPatients post liver transplantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient with incisional hernia post liver transplantation

You may qualify if:

  • Incisional hernia
  • Laparoscopic repair possible

You may not qualify if:

  • Other types of ventral hernias
  • Laparoscopy not possible

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Interventions

Surgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Priv.-Doz. M.D.

Study Record Dates

First Submitted

April 24, 2014

First Posted

April 25, 2014

Study Start

January 1, 2013

Primary Completion

December 1, 2013

Study Completion

February 1, 2014

Last Updated

April 25, 2014

Record last verified: 2014-04

Locations

AU(1)