Chronic Pain After Groin Hernia Surgery in Women

Hernia, Inguinal Clinical Trial

Official title:

Chronic Pain After Groin Hernia Surgery in Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04228536
• Other study ID #: 2019-00041
• Status: Completed
• Start date: September 1, 2012
• Est. completion date: December 31, 2019

Study information

• Verified date: February 2019
• Source: Umeå University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44915
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Pain
• Hernia
• Hernia, Femoral
• Hernia, Inguinal

Intervention

Procedure:
• Totally ExtraPeritoneal (TEP) repair

• TransAbdominal PrePeritoneal (TAPP) repair

• Open anterior mesh repair (OAM)

• Combined Anterior and Posterior technique (CAP)

• Open PrePeritoneal Mesh technique (OPPM)

• Sutured Repair

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Umeå University	Region Jamtland Harjedalen

References & Publications (1)

Fränneby U, Gunnarsson U, Andersson M, Heuman R, Nordin P, Nyrén 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age as a risk factors for chronic pain after groin hernia surgery	Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.	1 year after groin hernia surgery
Other	Sex as a risk factors for chronic pain after groin hernia surgery	Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure	1 year after groin hernia surgery
Other	Hernia anatomy as a risk factors for chronic pain after groin hernia surgery	Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure	1 year after groin hernia surgery
Other	Method of repair as a risk factors for chronic pain after groin hernia surgery	Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure	1 year after groin hernia surgery
Other	Acute surgery as a risk factors for chronic pain after groin hernia surgery	Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure	1 year after groin hernia surgery
Other	Annual surgeon volume as a risk factors for chronic pain after groin hernia surgery	Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.	1 year after groin hernia surgery
Other	ASA grade as a risk factors for chronic pain after groin hernia surgery	The ASA physical status classification system is a system for assessing the fitness of patients before surgery.	1 year after groin hernia surgery
Other	BMI as a risk factors for chronic pain after groin hernia surgery	weight and height will be combined to report BMI in kg/m^2	1 year after groin hernia surgery
Primary	Rate of chronic pain in women 1 year after groin hernia surgery.	Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.	1 year after groin hernia surgery
Primary	Rate of chronic pain in men 1 year after groin hernia surgery.	Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.	1 year after groin hernia surgery
Secondary	Rate of reoperation for recurrence.		Through study completion, minimum follow up 1 year