Chronic Postherniotomy PainNCT00649142
Predisposing Factors for Chronic Postherniotomy Pain
A study testing Open sutured mesh repair and Laparoscopic mesh glue fixation in people with Chronic Postherniotomy Pain, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in 2 countries.
Trial summary
Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair. However no prospective study has investigated potential predisposing factors for development of pain, including genetic, psychosocial and detailed neurophysiological assessment of surgical method. Read more about this study
- Who is it for?
- Ages 18 to 80 years, men only
- Conditions the study is for
- Chronic Postherniotomy Pain
- What is being tested?
- Open sutured mesh repair and Laparoscopic mesh glue fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 455 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jan 2007to Sep 2008
- Phase
- Interventional
- 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 18 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (>18 years)
- Male
- Primary unilateral groin hernia
- Ability to use pain scales
Who cannot join
- Neurological disease
- Diabetes with late stage complications
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain
Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair. However no prospective study has investigated potential predisposing factors for development of pain, including genetic, psychosocial and detailed neurophysiological assessment of surgical method.
The current study will assess the above factors in a prospective study.
- Conditions
- Chronic Postherniotomy Pain
- Being tested
- Open sutured mesh repair, Laparoscopic mesh glue fixation
- Keywords
- Groin hernia, Chronic postsurgical pain, open mesh repair, laparoscopic mesh glue fixation, Sensory changes after groin hernia repair
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open sutured mesh repairProcedure or surgery
Open sutured mesh repair
Laparoscopic mesh glue fixationProcedure or surgery
Laparoscopic mesh glue fixation
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | Open sutured mesh repair Receives: Procedure: Open sutured mesh repair |
| B | Active comparator | Laparoscopic mesh glue fixation Receives: Procedure: Laparoscopic mesh glue fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of chronic pain
Measured: 6 months postoperatively
Secondary outcomes (2)
Changes in sensory function
Measured: 6 months
Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2008 (estimated)
- Study startJan 2007
- Primary completionSep 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Postherniotomy PainStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 455 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Aesculap AG, Baxter Healthcare Corporation
- Investigators
- Henrik Kehlet, Professor, Ph D, M.D, Study chair, Rigshospitalet, Copenhagen, section for surgical pathophysiologyReinhard Bittner, Prof. Ph D, M.D., Principal investigator, Marienhospital Stuttgart, Viszeralchirurgie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00649142
- Sponsor's protocol ID
- (KF) 01 294867
- Status last verified
- Sep 2008
- First submitted
- 28 Mar 2008
- Last updated
- 22 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Aasvang E, Kehlet H. Surgical management of chronic pain after inguinal hernia repair. Br J Surg. 2005 Jul;92(7):795-801. doi: 10.1002/bjs.5103.
PubMed 15962258
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of Predisposing Factors for Chronic Postherniotomy Pain
- ClinicalTrials.gov ID
- NCT00649142
- Acronym / sponsor ID
- (KF) 01 294867
- Conditions
- Chronic Postherniotomy Pain
- Keywords
- Groin hernia, Chronic postsurgical pain, open mesh repair, laparoscopic mesh glue fixation, Sensory changes after groin hernia repair
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 455 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Aesculap AG, Baxter Healthcare Corporation
- Study start
- Jan 2007
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 1 Apr 2008 (estimated)
- 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.
Chronic pain affects pain in 5-8% of patients more than a year after groin hernia repair. However no prospective study has investigated potential predisposing factors for development of pain, including genetic, psychosocial and detailed neurophysiological assessment of surgical method.
The current study will assess the above factors in a prospective study.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Procedure: Open sutured mesh repairOpen sutured mesh repair |
| B | Active comparator | Procedure: Laparoscopic mesh glue fixationLaparoscopic mesh glue fixation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult (>18 years)
- Male
- Primary unilateral groin hernia
- Ability to use pain scales
Key exclusion criteria (2 listed)
- Neurological disease
- Diabetes with late stage complications
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 |
|---|---|---|
| Open sutured mesh repairOpen sutured mesh repair | Procedure or surgery | A |
| Laparoscopic mesh glue fixationLaparoscopic mesh glue fixation | Procedure or surgery | B |
Primary outcome
Frequency of chronic pain
Time frame: 6 months postoperatively
2 secondary outcomes
Changes in sensory function
Time frame: 6 months
Influence of genotype, preoperative pain, intraoperative findings, psycho-social factors
Time frame: 6 months
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 22 Jan 2009.
- Background: PubMed 15962258Aasvang E, Kehlet H. Surgical management of chronic pain after inguinal hernia repair. Br J Surg. 2005 Jul;92(7):795-801. doi: 10.1002/bjs.5103.
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.
Henrik Kehlet, Professor, Ph D, M.D study chair
Rigshospitalet, Copenhagen, section for surgical pathophysiology
Reinhard Bittner, Prof. Ph D, M.D. principal investigator
Marienhospital Stuttgart, Viszeralchirurgie
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open sutured mesh repair and Laparoscopic mesh glue fixation in people with Chronic Postherniotomy Pain, run by Copenhagen University Hospital, Rigshospitalet at 2 sites in 2 countries.
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 4 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 22 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Frequency of chronic pain (time frame: 6 months postoperatively). 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 NCT00649142, which also lists 1 linked publication.
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 22 Jan 2009.