NCT Number: NCT04228536
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.
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Conditions
Age range
15 year and older
Sex eligibility
All sexes
Study type
Observational
About this study
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:
- No pain.
- Pain present, but easily ignored.
- Pain present, cannot be ignored, but does not interfere with everyday activities.
- Pain present, cannot be ignored, and interferes with concentration on everyday activities.
- Pain present, interferes with most activities.
- Pain present, necessitating bed rest.
- 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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
TransAbdominal PrePeritoneal (TAPP) repair
ProcedureOpen anterior mesh repair (OAM)
ProcedureOther names: Lichtenstein
Combined Anterior and Posterior technique (CAP)
ProcedureOther names: Plug, Prolene Hernis System (PHS), Onstep, TransInguinalPrePeritoneal repair (TIPP)
Open PrePeritoneal Mesh technique (OPPM)
ProcedureOther names: Nyhus, Stoppa, Hives
Sutured Repair
ProcedureOther names: McVay, Bassini, Shouldice, Marcy
Primary outcomes
-
Rate of chronic pain in women 1 year after groin hernia surgery.
Time frame: 1 year after groin hernia surgery
Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.
-
Rate of chronic pain in men 1 year after groin hernia surgery.
Time frame: 1 year after groin hernia surgery
Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.
Secondary outcomes
-
Rate of reoperation for recurrence.
Time frame: Through study completion, minimum follow up 1 year
Other outcomes
-
Age as a risk factors for chronic pain after groin hernia surgery
Time frame: 1 year after groin hernia surgery
Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.
-
Sex as a risk factors for chronic pain after groin hernia surgery
Time frame: 1 year after groin hernia surgery
Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure
-
Hernia anatomy as a risk factors for chronic pain after groin hernia surgery
Time frame: 1 year after groin hernia surgery
Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure
-
Method of repair as a risk factors for chronic pain after groin hernia surgery
Time frame: 1 year after groin hernia surgery
Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure
-
Acute surgery as a risk factors for chronic pain after groin hernia surgery
Time frame: 1 year after groin hernia surgery
Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure
-
Annual surgeon volume as a risk factors for chronic pain after groin hernia surgery
Time frame: 1 year after groin hernia surgery
Using Inguinal Pain Questionnaire (IPQ) for patient reported outcome measure.
-
ASA grade as a risk factors for chronic pain after groin hernia surgery
Time frame: 1 year after groin hernia surgery
The 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 surgery
Time frame: 1 year after groin hernia surgery
weight and height will be combined to report BMI in kg/m^2
Sponsors and collaborators
Lead sponsor
Umeå University
Other
Collaborators
- Region Jämtland Härjedalen
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2018
- Study completion
- 2019
- First posted
- Jan 14, 2020
- Registry last updated
- Jan 14, 2020
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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