Chronic Pain After Groin Hernia Surgery in Women

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.

Study Overview

• Status: Completed
• Conditions: Hernia, Inguinal; Hernia, Femoral
• Intervention / Treatment: Procedure: Totally ExtraPeritoneal (TEP) repair; Procedure: TransAbdominal PrePeritoneal (TAPP) repair; Procedure: Open anterior mesh repair (OAM); Procedure: Combined Anterior and Posterior technique (CAP); Procedure: Open PrePeritoneal Mesh technique (OPPM); Procedure: Sutured Repair

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.

• Study Type: Observational
• Enrollment (Actual): 44915

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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

Description

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.

Study Plan

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
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
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 Outcome Measures

Outcome Measure	Time Frame
Rate of reoperation for recurrence.	Through study completion, minimum follow up 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Umeå University
• Collaborators: Region Jämtland Härjedalen
• Investigators: Principal Investigator: Pär Nordin, M.D., Ph.D., Umeå University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: August 13, 2019
• First Submitted That Met QC Criteria: January 13, 2020
• First Posted (Actual): January 14, 2020

Study Record Updates

• Last Update Posted (Actual): January 14, 2020
• Last Update Submitted That Met QC Criteria: January 13, 2020
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: chronic pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal; Chronic Pain; Hernia, Femoral
• Other Study ID Numbers: 2019-00041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No