Clinical Trial: Chronic Pain After Groin Hernia Repair

Study Status: Completed
Recruit Status: Completed
Study Type: Observational [Patient Registry]

Official Title: Chronic Pain After Groin Hernia Repair, Impact of Method of Surgery

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 Summary:

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.

Starting 2013, a questionnaire regarding Patient Reported Outcome Measure (PROM) is sent to all patients having an groin hernia repair from September 2012 until December 2014. Patients are identified in the SHR and postal addresses obtained through the register of the whole population, using the PIN.

Patients were sent a short form of Inguinal Pain Questionnaire (IPQ). IPQ is a validated pain questionnaire, specifically desig
Sponsor: Umeå University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome: Reoperation for recurrence [ Time Frame: Up to 4 years from primary surgery ]

Reoperation for recurrence in the same groin (all types of groin hernias)


Original Secondary Outcome: Same as current

Information By: Umeå University

Dates:
Date Received: April 8, 2016
Date Started: September 1, 2013
Date Completion:
Last Updated: February 22, 2017
Last Verified: April 2016