Incisional HerniaLACHNCT00537927
LACH-Trial: LAparoscopic Correction of Hernia
A study testing laparoscopic correction of hernia with mesh in people with Incisional Hernia and Ventral Hernia, run by Ziekenhuisgroep Twente at 1 site in Netherlands.
Trial summary
Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of postoperative pain. The study hypothesis is that there is no difference in postoperative pain between different methods to fix the mesh in laparoscopic incisional / ventral hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Incisional Hernia, Ventral Hernia
- What is being tested?
- laparoscopic correction of hernia with mesh
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 215 participants
- Where
- 1 siteNetherlands
- Study dates
- Aug 2005to Jan 2009
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Non-acute incisional hernia of the abdominal wall or ventral hernia of the abdominal wall
- Informed consent
- Elective surgery
Who cannot join
- < 18 years and > 80 years
- Prednison > 15 mg/24hr, started more than 2 weeks prior to surgery
- Chronical cough (severe COPD etc)
- Ascites
- Peritoneal dialysis
- Current abdominal infection
- Complete loss of abdominal domain due to hernia (diameter more than 10 cm?)
- Re-laparoscopic correction of ventral hernia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.
Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of postoperative pain.
The study hypothesis is that there is no difference in postoperative pain between different methods to fix the mesh in laparoscopic incisional / ventral hernia repair.
Read the detailed description
One of the complications in laparoscopic incisional / ventral hernia repair is postoperative pain. Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of this postoperative pain. Fixation of the mesh might also influence other outcome parameters such as return to preoperative activities, costs and recurrence rate.
The study hypothesis is that there is no difference in postoperative pain when comparing three commonly used mesh fixation techniques in laparoscopic incisional / ventral hernia repair.
- Conditions
- Incisional Hernia, Ventral Hernia
- Being tested
- laparoscopic correction of hernia with mesh
- Keywords
- laparoscopic correction, ventral and incisional hernia, mesh fixation, postoperative pain
- Medical subject headings
- Incisional Hernia, Hernia, Ventral, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic correction of hernia with meshProcedure or surgery
Also called DualMesh, Mersilene, Vicryl, ProTack
Correction of hernia with mesh and fixation of mesh using one of the arms.
| Study group | Role | What they receive |
|---|---|---|
| 0 | Active comparator | fixation of mesh with a single crown of tacks and absorbable sutures Receives: Procedure: laparoscopic correction of hernia with mesh |
| 1 | Active comparator | fixation of mesh with a double crown of tacks and no sutures Receives: Procedure: laparoscopic correction of hernia with mesh |
| 2 | Active comparator | fixation of mesh with a single crown of tacks and non-absorbable sutures Receives: Procedure: laparoscopic correction of hernia with mesh |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of postoperative pain
Measured: one year
Secondary outcomes (5)
Quality of life
Measured: one year
Overall satisfaction
Measured: one year
Postoperative stay
Measured: one month
Per- and postoperative morbidity
Measured: one month
Recurrence
Measured: Three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2007 (estimated)
- Study startAug 2005
- Primary completionOct 2008
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 215 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ziekenhuisgroep Twente
- Sponsor type
- University, hospital or other
- Investigators
- Eelco B Wassenaar, MD, Principal investigator, Ziekenhuisgroep TwenteSrjdan Rakic, MD, PhD, Study director, Ziekenhuisgroep Twente
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00537927
- Sponsor's protocol ID
- P05-28
- Acronym
- LACH
- Status last verified
- Jan 2009
- First submitted
- 1 Oct 2007
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Goodney PP, Birkmeyer CM, Birkmeyer JD. Short-term outcomes of laparoscopic and open ventral hernia repair: a meta-analysis. Arch Surg. 2002 Oct;137(10):1161-5. doi: 10.1001/archsurg.137.10.1161.
PubMed 12361426DeMaria EJ, Moss JM, Sugerman HJ. Laparoscopic intraperitoneal polytetrafluoroethylene (PTFE) prosthetic patch repair of ventral hernia. Prospective comparison to open prefascial polypropylene mesh repair. Surg Endosc. 2000 Apr;14(4):326-9. doi: 10.1007/s004640020013.
PubMed 10790548LeBlanc KA. Laparoscopic incisional and ventral hernia repair: complications-how to avoid and handle. Hernia. 2004 Dec;8(4):323-31. doi: 10.1007/s10029-004-0250-5.
PubMed 15235939Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab.
PubMed 14501505Wassenaar E, Schoenmaeckers E, Raymakers J, van der Palen J, Rakic S. Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques. Surg Endosc. 2010 Jun;24(6):1296-302. doi: 10.1007/s00464-009-0763-1. Epub 2009 Dec 24.
PubMed 20033726
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.
- ClinicalTrials.gov ID
- NCT00537927
- Acronym / sponsor ID
- LACH / P05-28
- Conditions
- Incisional Hernia, Ventral Hernia
- Keywords
- laparoscopic correction, ventral and incisional hernia, mesh fixation, postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 215 participants (actual)
- Lead sponsor
- Ziekenhuisgroep TwenteUniversity, hospital or other
- Study start
- Aug 2005
- Primary completion
- Oct 2008 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 2 Oct 2007 (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.
Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of postoperative pain.
The study hypothesis is that there is no difference in postoperative pain between different methods to fix the mesh in laparoscopic incisional / ventral hernia repair.
Detailed description
One of the complications in laparoscopic incisional / ventral hernia repair is postoperative pain. Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair might influence the degree of this postoperative pain. Fixation of the mesh might also influence other outcome parameters such as return to preoperative activities, costs and recurrence rate.
The study hypothesis is that there is no difference in postoperative pain when comparing three commonly used mesh fixation techniques in laparoscopic incisional / ventral hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 0 | Active comparator | Procedure: laparoscopic correction of hernia with meshfixation of mesh with a single crown of tacks and absorbable sutures |
| 1 | Active comparator | Procedure: laparoscopic correction of hernia with meshfixation of mesh with a double crown of tacks and no sutures |
| 2 | Active comparator | Procedure: laparoscopic correction of hernia with meshfixation of mesh with a single crown of tacks and non-absorbable sutures |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Non-acute incisional hernia of the abdominal wall or ventral hernia of the abdominal wall
- Informed consent
- Elective surgery
Key exclusion criteria (8 listed)
- < 18 years and > 80 years
- Prednison > 15 mg/24hr, started more than 2 weeks prior to surgery
- Chronical cough (severe COPD etc)
- Ascites
- Peritoneal dialysis
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 |
|---|---|---|
| laparoscopic correction of hernia with meshAlso: DualMesh, Mersilene, Vicryl, ProTackCorrection of hernia with mesh and fixation of mesh using one of the arms. | Procedure or surgery | 0, 1, 2 |
Primary outcome
Assessment of postoperative pain
Time frame: one year
5 secondary outcomes
Quality of life
Time frame: one year
Overall satisfaction
Time frame: one year
Postoperative stay
Time frame: one month
Per- and postoperative morbidity
Time frame: one month
Recurrence
Time frame: Three years
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 18 Feb 2009.
- Background: PubMed 12361426Goodney PP, Birkmeyer CM, Birkmeyer JD. Short-term outcomes of laparoscopic and open ventral hernia repair: a meta-analysis. Arch Surg. 2002 Oct;137(10):1161-5. doi: 10.1001/archsurg.137.10.1161.
- Background: PubMed 10790548DeMaria EJ, Moss JM, Sugerman HJ. Laparoscopic intraperitoneal polytetrafluoroethylene (PTFE) prosthetic patch repair of ventral hernia. Prospective comparison to open prefascial polypropylene mesh repair. Surg Endosc. 2000 Apr;14(4):326-9. doi: 10.1007/s004640020013.
- Background: PubMed 15235939LeBlanc KA. Laparoscopic incisional and ventral hernia repair: complications-how to avoid and handle. Hernia. 2004 Dec;8(4):323-31. doi: 10.1007/s10029-004-0250-5.
- Background: PubMed 14501505Heniford BT, Park A, Ramshaw BJ, Voeller G. Laparoscopic repair of ventral hernias: nine years' experience with 850 consecutive hernias. Ann Surg. 2003 Sep;238(3):391-9; discussion 399-400. doi: 10.1097/01.sla.0000086662.49499.ab.
- Derived from this study: PubMed 20033726Wassenaar E, Schoenmaeckers E, Raymakers J, van der Palen J, Rakic S. Mesh-fixation method and pain and quality of life after laparoscopic ventral or incisional hernia repair: a randomized trial of three fixation techniques. Surg Endosc. 2010 Jun;24(6):1296-302. doi: 10.1007/s00464-009-0763-1. Epub 2009 Dec 24.
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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.
Eelco B Wassenaar, MD principal investigator
Ziekenhuisgroep Twente
Srjdan Rakic, MD, PhD study director
Ziekenhuisgroep Twente
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic correction of hernia with mesh in people with Incisional Hernia and Ventral Hernia, run by Ziekenhuisgroep Twente at 1 site in Netherlands.
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 8 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 18 Feb 2009. 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 Netherlands. 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?
Assessment of postoperative pain (time frame: one year). 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 NCT00537927, which also lists 5 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 18 Feb 2009; AzTrials last refreshed its copy on 1 Nov 2026.