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Hernia, InguinalNCT04228536

Chronic Pain After Groin Hernia Surgery in Women

An observational study of Hernia, Inguinal and Hernia, Femoral, run by Umeå University.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of this study was to evaluate chronic pain and reoperation rates due to recurrence after groin hernia surgery in women compared to men and surgical method. Read more about this study

Who is it for?
Ages 15 years and older
Conditions the study is for
Hernia, Inguinal, Hernia, Femoral
What is being tested?
Totally ExtraPeritoneal (TEP) repair, TransAbdominal PrePeritoneal (TAPP) repair and Open anterior mesh repair (OAM)
Type of treatment
Surgery or procedure
How many people
44,915 participants
Where
No sites listed yet
Study dates
1 Sep 2012to 31 Dec 2019
How long will I take part?
1 Year
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All patients 15 years and older included in the SHR between 1 Sept. 2012 and 31 Aug 2017.

Who may be able to join

  • All patients 15 years and older included in the SHR between 1 Sept. 2012 and 31 Aug 2017. Both elective and acute surgery is included.

Who cannot join

  • Patients not responding to questionnaire. Patients were the first operation during inclusion period was a reoperation.
  • Patient with bilateral operations during the study-period are only included once.

About this study

The goal of this study was to evaluate chronic pain and reoperation rates due to recurrence after groin hernia surgery in women compared to men and surgical method.

Read the detailed description

INTRODUCTION:

Groin hernia surgery in women is much less common than in men, still women represent a large patient group since groin hernia surgery is one of the most common operations in general surgery. In Sweden, approximately 16 000 groin hernia surgeries are being performed annually, of these 8 % are performed in women. Management and method of repair in women is largely based on subgroup analyses and register studies, there is a lack of randomised controlled trials focusing on women. Previous studies have shown that femoral hernias are more common in women than in men, that women have a higher risk of emergency operation, and a higher incidence of reoperation which serves as a marker of recurrence. Chronic pain is common after herniorraphy and an important quality marker of the performed surgery. There are indications that women suffer of higher rates of both short term and chronic post-herniorraphy pain. The introduction of mesh techniques in groin hernia surgery has considerably decreased recurrence rates. To further improve outcome after groin hernia surgery in women there is a need for more evidence of the most appropriate surgical approach in terms of chronic pain.The goal of this study was to evaluate chronic pain and reoperation rates due to recurrence after groin hernia surgery in women compared to men.

METHODS

This study is based on a patient reported outcome measure (PROM) questionnaire, crosslinked to the Swedish Hernia Registry one year after primary surgery. What the investigators would like to call a Register-PROM-study.

The Swedish Hernia Registry (SHR)

SHR is a nationwide registry which covers more than 95% of all performed groin hernia repairs in Sweden. Patients are included upon surgery. Registered parameters include details about hernia anatomy, method of repair, American Society of Anesthesiologists (ASA) Physical Status and early complications (within 30 days), among others. Using the Swedish personal identity number, where each inhabitant has a unique number, it is possible to follow patients regardless of where the participants have their primary or recurrence operation.

Questionnaire

To measure the postoperative pain one year after primary operation a shortened version of the previously validated Inguinal Pain Questionnaire (IPQ) was used. Patients were asked to grade the worst pain the participants had felt in the operated groin during the last week. Scores were:

  1. No pain.
  2. Pain present, but easily ignored.
  3. Pain present, cannot be ignored, but does not interfere with everyday activities.
  4. Pain present, cannot be ignored, and interferes with concentration on everyday activities.
  5. Pain present, interferes with most activities.
  6. Pain present, necessitating bed rest.
  7. Pain present, prompt medical advice sought. Scores of 1-3 were defined as no pain and scores of 4-7 as chronic pain.

Data Collection

The questionnaire is sent by regular mail to everyone included in the SHR one year after surgery. Answers are recorded in the SHR. The participants are able to answer the questionnaire by mail or a web based questionnaire. Postal addresses were obtained through the Swedish population register. If no response had been received within 1 month a reminder was sent. A previous study with a similar cohort has analyzed loss to follow up and reliability of the method.

Being tested
Totally ExtraPeritoneal (TEP) repair, TransAbdominal PrePeritoneal (TAPP) repair, Open anterior mesh repair (OAM), Combined Anterior and Posterior technique (CAP), Open PrePeritoneal Mesh technique (OPPM)
Keywords
chronic pain
Medical subject headings
Hernia, Inguinal, Hernia, Femoral, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Totally ExtraPeritoneal (TEP) repairProcedure or surgery

  • TransAbdominal PrePeritoneal (TAPP) repairProcedure or surgery

  • Open anterior mesh repair (OAM)Procedure or surgery

    Also called Lichtenstein

  • Combined Anterior and Posterior technique (CAP)Procedure or surgery

    Also called Plug, Prolene Hernis System (PHS), Onstep, TransInguinalPrePeritoneal repair (TIPP)

  • Open PrePeritoneal Mesh technique (OPPM)Procedure or surgery

    Also called Nyhus, Stoppa, Hives

  • Sutured RepairProcedure or surgery

    Also called McVay, Bassini, Shouldice, Marcy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of chronic pain in women 1 year after groin hernia surgery.

    Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.

    Measured: 1 year after groin hernia surgery

  2. Rate of chronic pain in men 1 year after groin hernia surgery.

    Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.

    Measured: 1 year after groin hernia surgery

Secondary outcomes (1)
  1. Rate of reoperation for recurrence.

    Measured: Through study completion, minimum follow up 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jan 2020
  2. Study start1 Sep 2012
  3. Primary completion31 Dec 2018
  4. Study completion31 Dec 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
44,915 participants (actual)
Target duration
1 Year
IDs, dates and publications
ClinicalTrials.gov ID
NCT04228536
Sponsor's protocol ID
2019-00041
Other IDs
2019
Status last verified
Feb 2019
First submitted
13 Aug 2019
Last updated
14 Jan 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Franneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyren O, Sandblom G. Validation of an Inguinal Pain Questionnaire for assessment of chronic pain after groin hernia repair. Br J Surg. 2008 Apr;95(4):488-93. doi: 10.1002/bjs.6014.

    PubMed 18161900
  • Jakobsson E, Lundstrom KJ, Holmberg H, de la Croix H, Nordin P. Chronic Pain After Groin Hernia Surgery in Women: A Patient-reported Outcome Study Based on Data From the Swedish Hernia Register. Ann Surg. 2022 Feb 1;275(2):213-219. doi: 10.1097/SLA.0000000000005194.

    PubMed 35007224

Questions about this trial

What is this clinical trial studying?

An observational study of Hernia, Inguinal and Hernia, Femoral, run by Umeå University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of chronic pain in women 1 year after groin hernia surgery. (time frame: 1 year after groin hernia surgery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04228536, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2020.

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