Hernia, InguinalNCT04228536
Chronic Pain After Groin Hernia Surgery in Women
An observational study of Hernia, Inguinal and Hernia, Femoral, run by Umeå University.
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:
- 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.
- Conditions
- Hernia, Inguinal, Hernia, Femoral
- 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.
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
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)
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.
- First posted14 Jan 2020
- Study start1 Sep 2012
- Primary completion31 Dec 2018
- Study completion31 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hernia, InguinalStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Collaborators
- Region Jämtland Härjedalen
- Responsible party
- Sponsor
- Investigators
- Pär Nordin, M.D., Ph.D., Principal investigator, Umeå University
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 18161900Jakobsson 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
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Pain After Groin Hernia Surgery in Women
- ClinicalTrials.gov ID
- NCT04228536
- Acronym / sponsor ID
- 2019-00041
- Conditions
- Hernia, Inguinal, Hernia, Femoral
- Keywords
- chronic pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 44,915 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Collaborators
- Region Jämtland Härjedalen
- Study start
- 1 Sep 2012 (actual)
- Primary completion
- 31 Dec 2018 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 14 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients 15 years and older included in the SHR between 1 Sept. 2012 and 31 Aug 2017.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Totally ExtraPeritoneal (TEP) repair | Procedure or surgery | – |
| TransAbdominal PrePeritoneal (TAPP) repair | Procedure or surgery | – |
| Open anterior mesh repair (OAM)Also: Lichtenstein | Procedure or surgery | – |
| Combined Anterior and Posterior technique (CAP)Also: Plug, Prolene Hernis System (PHS), Onstep, TransInguinalPrePeritoneal repair (TIPP) | Procedure or surgery | – |
| Open PrePeritoneal Mesh technique (OPPM)Also: Nyhus, Stoppa, Hives | Procedure or surgery | – |
| Sutured RepairAlso: McVay, Bassini, Shouldice, Marcy | Procedure or surgery | – |
Primary outcome
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.
1 secondary outcome
Rate of reoperation for recurrence.
Time frame: Through study completion, minimum follow up 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2020.
- Background: PubMed 18161900Franneby 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.
- Derived from this study: PubMed 35007224Jakobsson 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pär Nordin, M.D., Ph.D. principal investigator
Umeå University
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.