Inguinal HerniaLap-LyskeNCT00962338
Pain and Convalescence After Laparoscopic Groin Hernia Repair
An observational study of Inguinal Hernia and Convalescence, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
The investigators want to identify limiting factors for short convalescence after laparoscopic groin hernia repair. Before the operation patients are given intensive structured information about one day´s convalescence. Patients fill out questionnaire before operation about several clinically relevant parameters. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inguinal Hernia, Convalescence
- What is being tested?
- Information
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 210 participants
- Where
- 1 siteDenmark
- Study dates
- Aug 2009to Jun 2011
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population are from Region Sjaelland and are planned for laparoscopic inguinal or femoral herniorrhaphy. Single university hospital department i Denmark.
Who may be able to join
- planned laparoscopic inguinal or femoral herniorrhaphy
- ASA class I-II
- speak and read danish
Who cannot join
- converting to open operation
- low compliance (dementia, psychiatric disorder)
- use of morphine or similar drugs daily in the last month
- complications to the operation
Trial locations and contacts
1 site in 1 country.
About this study
The investigators want to identify limiting factors for short convalescence after laparoscopic groin hernia repair. Before the operation patients are given intensive structured information about one day´s convalescence. Patients fill out questionnaire before operation about several clinically relevant parameters. This is also done first 3 days after operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and 6 months.
- Conditions
- Inguinal Hernia, Convalescence
- Being tested
- Information
- Keywords
- convalescence, pain, nausea, vomiting, sexual dysfunction
- Medical subject headings
- Hernia, Inguinal, Convalescence, Pain, Nausea, Vomiting, Sexual Dysfunction, Physiological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
InformationBehavioural
Also called Groin hernia repair, TAPP, Convalescence
Information on short convalescence (1 day). Example: Operated today and getting started with normal activities again tomorrow.
| Study group | Role | What they receive |
|---|---|---|
| lap. inguinal herniorrhaphy | Patients undergoing planned lap. inguinal herniorrhaphy Receives: Behavioral: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
duration of convalescence
Measured: 3 weeks in average
Secondary outcomes (9)
Pain scores on visual analog scale and verbal rating scale
daily first 4 days, after 1 and 6 months
Measured: 6 months
fatigue scores on numeric rating scale (1-10)
daily first 4 days, 1 and 6 months
Measured: 6 months
sexual dysfunction
Measured: 6 months
nausea scores on verbal rating scale
Measured: 3 days
vomiting
Measured: 3 days
wellbeing scores on visual analog scale
Measured: 6 months
Hospital anxiety and depression scale (HAD)
Measured: Baseline (before operation)
Pain catastrophizing scale (PCS)
Measured: Baseline (before operation)
Activity assessment scale (AAS)
Functional status
Measured: Baseline (before operation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionDec 2010
- Study completionJun 2011
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 Inguinal HerniaStudies of the same condition, open and under way.
- More trials run by Zealand University HospitalThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mette Astrup Madsen, Zealand University Hospital
- Investigators
- Mette A Tolver, M.D., Principal investigator, University Hospital Køge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00962338
- Sponsor's protocol ID
- SJ-125
- Acronym
- Lap-Lyske
- Status last verified
- Aug 2024
- First submitted
- 19 Aug 2009
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tolver MA, Rosenberg J. Pain during sexual activity before and after laparoscopic inguinal hernia repair. Surg Endosc. 2015 Dec;29(12):3722-5. doi: 10.1007/s00464-015-4143-8. Epub 2015 Mar 18.
PubMed 25783834Tolver MA, Strandfelt P, Rosenberg J, Bisgaard T. Female gender is a risk factor for pain, discomfort, and fatigue after laparoscopic groin hernia repair. Hernia. 2013 Jun;17(3):321-7. doi: 10.1007/s10029-012-0956-8. Epub 2012 Jul 12.
PubMed 22790511
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain and Convalescence After Laparoscopic Groin Hernia Repair
- ClinicalTrials.gov ID
- NCT00962338
- Acronym / sponsor ID
- Lap-Lyske / SJ-125
- Conditions
- Inguinal Hernia, Convalescence
- Keywords
- convalescence, pain, nausea, vomiting, sexual dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 20 Aug 2009 (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.
The investigators want to identify limiting factors for short convalescence after laparoscopic groin hernia repair. Before the operation patients are given intensive structured information about one day´s convalescence. Patients fill out questionnaire before operation about several clinically relevant parameters. This is also done first 3 days after operation and after 1 month and 6 months. The patients are seen for clinical control at 1 and 6 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lap. inguinal herniorrhaphy | – | Behavioral: InformationPatients undergoing planned lap. inguinal herniorrhaphy |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population are from Region Sjaelland and are planned for laparoscopic inguinal or femoral herniorrhaphy. Single university hospital department i Denmark.
Key inclusion criteria (3 listed)
- planned laparoscopic inguinal or femoral herniorrhaphy
- ASA class I-II
- speak and read danish
Key exclusion criteria (4 listed)
- converting to open operation
- low compliance (dementia, psychiatric disorder)
- use of morphine or similar drugs daily in the last month
- complications to the operation
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 |
|---|---|---|
| InformationAlso: Groin hernia repair, TAPP, ConvalescenceInformation on short convalescence (1 day). Example: Operated today and getting started with normal activities again tomorrow. | Behavioural | lap. inguinal herniorrhaphy |
Primary outcome
duration of convalescence
Time frame: 3 weeks in average
9 secondary outcomes
Pain scores on visual analog scale and verbal rating scale
Time frame: 6 months
fatigue scores on numeric rating scale (1-10)
Time frame: 6 months
sexual dysfunction
Time frame: 6 months
nausea scores on verbal rating scale
Time frame: 3 days
vomiting
Time frame: 3 days
wellbeing scores on visual analog scale
Time frame: 6 months
Hospital anxiety and depression scale (HAD)
Time frame: Baseline (before operation)
Pain catastrophizing scale (PCS)
Time frame: Baseline (before operation)
Activity assessment scale (AAS)
Time frame: Baseline (before operation)
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 26 Aug 2024.
- Derived from this study: PubMed 25783834Tolver MA, Rosenberg J. Pain during sexual activity before and after laparoscopic inguinal hernia repair. Surg Endosc. 2015 Dec;29(12):3722-5. doi: 10.1007/s00464-015-4143-8. Epub 2015 Mar 18.
- Derived from this study: PubMed 22790511Tolver MA, Strandfelt P, Rosenberg J, Bisgaard T. Female gender is a risk factor for pain, discomfort, and fatigue after laparoscopic groin hernia repair. Hernia. 2013 Jun;17(3):321-7. doi: 10.1007/s10029-012-0956-8. Epub 2012 Jul 12.
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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.
Mette A Tolver, M.D. principal investigator
University Hospital Køge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inguinal Hernia and Convalescence, run by Zealand University Hospital at 1 site in Denmark.
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 3 inclusion and 4 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 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
duration of convalescence (time frame: 3 weeks in average). 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 NCT00962338, 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 26 Aug 2024.