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Chronic Pain After Groin Hernia Surgery in Women

Chronic Pain After Groin Hernia Surgery in Women

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04228536
Enrollment
44915
Registered
2020-01-14
Start date
2012-09-01
Completion date
2019-12-31
Last updated
2020-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Femoral, Hernia, Inguinal

Keywords

chronic pain

Brief 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.

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.

Interventions

PROCEDUREOpen anterior mesh repair (OAM)
PROCEDURECombined Anterior and Posterior technique (CAP)
PROCEDUREOpen PrePeritoneal Mesh technique (OPPM)
PROCEDURESutured Repair

Sponsors

Region Jämtland Härjedalen
CollaboratorOTHER
Umeå University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of chronic pain in women 1 year after groin hernia surgery.1 year after groin hernia surgeryUsing Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.
Rate of chronic pain in men 1 year after groin hernia surgery.1 year after groin hernia surgeryUsing Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.

Secondary

MeasureTime frame
Rate of reoperation for recurrence.Through study completion, minimum follow up 1 year

Other

MeasureTime frameDescription
Method of repair as a risk factors for chronic pain after groin hernia surgery1 year after groin hernia surgeryUsing Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure
Acute surgery as a risk factors for chronic pain after groin hernia surgery1 year after groin hernia surgeryUsing Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure
Age as a risk factors for chronic pain after groin hernia surgery1 year after groin hernia surgeryUsing Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.
ASA grade as a risk factors for chronic pain after groin hernia surgery1 year after groin hernia surgeryThe ASA physical status classification system is a system for assessing the fitness of patients before surgery.
BMI as a risk factors for chronic pain after groin hernia surgery1 year after groin hernia surgeryweight and height will be combined to report BMI in kg/m\^2
Annual surgeon volume as a risk factors for chronic pain after groin hernia surgery1 year after groin hernia surgeryUsing Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.
Sex as a risk factors for chronic pain after groin hernia surgery1 year after groin hernia surgeryUsing Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure
Hernia anatomy as a risk factors for chronic pain after groin hernia surgery1 year after groin hernia surgeryUsing Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026