Nationwide Results on Chronic Pain After Bilateral Transabdominal Preperitoneal Inguinal Hernia Repair (TAPP)

NCT ID: NCT03155230

Last Updated: 2019-03-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

209 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-01

Study Completion Date

2017-10-25

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Danish male patients who had undergone bilateral TAPP (July 2012 to June 2013) were recruited from the Danish Hernia Database and cross-checked with hospital files and the National Patient Registry. A standardized postal questionnaire was sent out two years after the index surgery to investigate Patients Related Outcome Measures (PROMs) such as chronic post-operative pain.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The present study was primarily undertaken to provide evidence for the risk of activity-related chronic postoperative inguinal pain following bilateral TAPP in an all-male Danish setting. Impaired sexual activity and sleep disturbance due to pain was also recorded. Data based on nationwide consecutive patients undergoing bilateral TAPP. Data collected for the Danish Inguinal Hernia Database, hospital files and the National Patient Registry (Denmark).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hernia, Inguinal Chronic Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Danish males,
* Age\>18 years
* Elective, bilateral TAPP due to inguinal hernia within the period from July 1, 2012 to June 30 2013

Exclusion Criteria

* age \<18 years
* miss-classified surgical code
* non-Danish speaking
* psychiatric anamneses
* regarded and non-compliant patients who had either died, emigrated or were lost to follow-up emergency repair
* femoral hernia repair
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hvidovre University Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Niels Johansen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Thue Bisgaard, professor

Role: STUDY_DIRECTOR

HvidovreUT

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Gastrounit, Surgical Division, Hvidovre Hospital, Denmark

Copenhagen, Danmark, Denmark

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

nj01042017

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Transabdominal Preperitoneal Inguinal Hernia Repair
NCT05839587 ACTIVE_NOT_RECRUITING NA