Chronic Pain After Groin Hernia Repair

February 22, 2017 updated by: Umeå University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

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 designed for groin hernia repair. The key question sent were " Grade the pain you felt in the operated groin the last week". Patients then answered in a 7 grades scale, where pain was correlated to if it could be ignored and to what extent it limited activities of daily life.

The questionnaire could be answered on regular paper or through a web questionnaire. One reminder was sent if no answer was collected within 1 month

The surgical methods were divided in 5 groups. Total ExtraPeritoneal (TEP) (Reference group), TransAbdominal PrePeritoneal (TAPP), Open anterior mesh technique (OAM i.e Lichtenstien), Open anterior non mesh ( ONM i.e Shouldice, McVay, Bassini), Combined Anterior end posterior Techniques (CAP i.e. Plug, Prolene Hernia System, Onestep), and Open Preperitoneal Mesh Techniques (OPT).

The method of surgery and other variables at index surgery for each individual patient was derived from the SHR through the PIN.

Using data from SHR. Multivariate analysis and propensity score matching will be used for analysis. Adjustments is made for all known and possible confounders such as age (above or below median age), gender, primary or recurrent hernia, emergent or electively operated, ASA class (≤2/>2),mesh weight (light (≤50g/m2) or heavy (> 50g/m2)), resident or consultant surgeon, annual surgeon volume (≤25/>25), hernia anatomy (femoral/medial/lateral- combined hernias considered as lateral), per or postoperative complication yes/no (hematoma, severe pain, infection and other complications), handling of the hernia sac (divided excised or invaginated) and type of hospital and others.

Missing data on different variables is managed by exclusion or imputation.

Adverse events such as preoperative complication is reported by the surgeon, and postoperative complications are detected by registry administrator at the surgical site by chart review 30 days postoperatively.

A reliability test (test-retest) is made on a random sample of patients 30 days apart.

A non responder analysis is conducted to asses wether patients not responding on the primary questionnaire differs from the responders according to perceived pain. This is done by randomly select patients to conduct a telephone interview.

Power calculations is based on the assumption of 75% response rate (0.75x30.000)= 22.500. Of these approximately 15% TEP=3375. Of TEP approximately 50% is done bilaterally, which is excluded from this study. Assuming a difference in pain of 4% in favor of TEP, it is needed more than 1200 patients in the TEP group to detect these differences, considered clinically meaningful.

Study Type

Observational

Enrollment (Actual)

24607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients registered in the Swedish hernia surgery.

Description

Inclusion criteria:

  • Unilateral, elective, groin hernia repair

Exclusion criteria:

  • Bilateral hernia repair
  • Emergent repair (<24h of duration with signs of incarceration)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reoperation for recurrence
Time Frame: Up to 4 years from primary surgery
Reoperation for recurrence in the same groin (all types of groin hernias)
Up to 4 years from primary surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Umeå University

Investigators

  • Principal Investigator: Pär Nordin, MD.Ph.D, Umea University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2013

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

February 1, 2017

Study Registration Dates

First Submitted

April 8, 2016

First Submitted That Met QC Criteria

April 25, 2016

First Posted (Estimate)

April 26, 2016

Study Record Updates

Last Update Posted (Actual)

February 24, 2017

Last Update Submitted That Met QC Criteria

February 22, 2017

Last Verified

April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • JLL-468171

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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