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Clinical Trials/NCT02751190
NCT02751190CompletedNot Applicable

Chronic Pain After Groin Hernia Repair, Impact of Method of Surgery

Umeå University0 sites24,607 target enrollmentStarted: September 1, 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
24,607
Primary Endpoint
Chronic post herniorraphy pain

Study Overview

Brief Summary

In the present study the investigators aimed to investigate the relationship between surgical methods and chronic pain in over 20 000 patients who underwent groin hernia repair in Sweden

Detailed Description

The Swedish Hernia Register (SHR) covers more than 98% of all groin hernia repairs in Sweden. Approximately 16.000 hernia repairs is performed annually. All patients are identified by the Swedish personal identification number (PIN), which is assigned at birth and used in virtually all contacts with Swedish healthcare and authorities.

All variables in the SHR are collected prospectively at the time of surgery, reported by the surgeon. Variables collected are numerous and contain among else age, gender, method of repair, anaesthesia type, hernia anatomy, recurrent or primary repair, sliding hernia, handling of the hernia sac, resident or consultant surgeon, annual surgeon volume, and type of unit.

A detailed variable list is found at the Swedish National Board of Welfare website (http://www.socialstyrelsen.se/register/registerservice/nationellakvalitetsregister/svensktbrackregister-nationell) Variables are validated thru annual validation of 10% of participating units where register data are checked against chart review made on a randomized sample of patients and units.

Patient can be registered more than once and be followed in time, which is possible by using the PIN.

Preoperative pain is not registered.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
15 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Chronic post herniorraphy pain

Time Frame: 1 year

A IPQ score of \> 3. Pain, which could not be ignored and affected concentration on activities and leisure activities

Secondary Outcomes

  • Reoperation for recurrence(Up to 4 years from primary surgery)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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