Inguinal HerniaNCT00793286
Stapler Versus Glue for Laparoscopic Groin Hernia Repair
A study testing Mesh fixation by staples and Mesh fixation by glue in people with Inguinal Hernia and Recurrence, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Repair of inguinal hernia is the most common operation of the general surgeon. In recent years, it was recognized that chronic postoperative pain is as important for postoperative outcome as recurrent hernia. The incidence of pain or discomfort ranges up to 60% of operated patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inguinal Hernia, Recurrence, Pain
- What is being tested?
- Mesh fixation by staples and Mesh fixation by glue
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- Aug 2004to Oct 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients scheduled for laparoscopic primary inguinal hernia repair
- uni- or bilateral patients with recurrent hernias after anterior surgical technique
- written informed consent
Who cannot join
- general contradictions for laparoscopy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Dep. of Visceral and Transplantsurgery, Bern University Hospital
Bern, 3010
About this study
Repair of inguinal hernia is the most common operation of the general surgeon. In recent years, it was recognized that chronic postoperative pain is as important for postoperative outcome as recurrent hernia. The incidence of pain or discomfort ranges up to 60% of operated patients. Despite the fact that laparoscopic hernia repair has been shown to reduce postoperative pain compared to open hernia repair, up to 5% of patients suffer from persistent discomfort. During that operation the mesh is either fixed using a stapler or tissue adhesive glue. With the current study we compare postoperative pain between patients undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high sensitivity.
Read the detailed description
Despite the fact that laparoscopic hernia repair has been shown to reduce postoperative pain compared to open hernia repair, up to 5% of patients suffer from persistent discomfort. During that operation the mesh is either fixed using a stapler or tissue adhesive glue. With the current study we compare postoperative pain between patients undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high sensitivity.
To perform a prospective randomized trial comparing pain after inguinal hernia repair using either fixation with stapler or histoacryl.
The standard TAPP procedure is performed under general anesthesia. Patients receive a single shot antibiotic prophylaxis, using Amoxicillin/Clavulanic Acids. Operations are performed by resident surgeons under supervision, consultants or senior consultants. After hernial sac dissection and retraction, preperitoneal fat is removed bluntly and Cooper's ligament is identified. A Vypro II ® (Ethicon ®) prosthetic mesh, 10x15 cm, is placed and fixed depending on randomization with either 5 mm Protack TM (Autosuture TM) or Glubran ® 2 (G.E.M., Viareggio, Italy). Randomization is performed in permutated block of 20 using sealed envelopes. Where tissue glue is used, meshs are additionally fixed caudally and laterocaudally. Peritoneal closure over the mesh is performed using resorptive sutures. Glubran ® 2 is a cyanoacrylate tissue adhesive. Follow up assessment: The use of analgesics in the postoperative period is standardized using paracetamol and morphine derivates. Following discharge patients are liberated of physical restrictions. Patient follow-up will be performed after 6 weeks, 6 and 12 months postoperatively. Patients are advised to mention pain in the operated groin area. In addition the Visual Analogue Scale is used to evaluate pain intensity.Statistical comparison is done using Mann-Whitney Test and Chi square Test (significance p < 0,05).
- Conditions
- Inguinal Hernia, Recurrence, Pain
- Being tested
- Mesh fixation by staples, Mesh fixation by glue
- Keywords
- inguinal hernia, laparoscopy, mesh
- Medical subject headings
- Hernia, Inguinal, Recurrence, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh fixation by staplesProcedure or surgery
Mesh fixation by staples
Mesh fixation by glueProcedure or surgery
Also called N-Butyl-2 Cyanoacrulat Glue
Mesh fixation by glue
| Study group | Role | What they receive |
|---|---|---|
| A | Other | Mesh fixation by staples Receives: Procedure: Mesh fixation by staples |
| B | Other | Mesh fixation by glue Receives: Procedure: Mesh fixation by glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Measured: 6 weeks, 6 months, 12 months postoperative
Secondary outcomes (3)
postoperative pain
Measured: 6 weeks, 6 months, 12 months postoperative
sensibility disorder
Measured: 6 weeks, 6 months, 12 months postoperative
intra- and postoperative complications
Measured: 6 weeks, 6 months, 12 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startAug 2004
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 Insel Gruppe AG, University Hospital BernThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Guido Beldi, MD, Principal investigator, Dep. of Visceral and Transplantsurgery, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793286
- Sponsor's protocol ID
- KEK_89_04
- Status last verified
- Nov 2008
- First submitted
- 18 Nov 2008
- Last updated
- 24 Nov 2008
- Results posted
- No
- Data monitoring committee
- No
Publications
McCormack K, Scott NW, Go PM, Ross S, Grant AM; EU Hernia Trialists Collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev. 2003;2003(1):CD001785. doi: 10.1002/14651858.CD001785.
PubMed 12535413Cunningham J, Temple WJ, Mitchell P, Nixon JA, Preshaw RM, Hagen NA. Cooperative hernia study. Pain in the postrepair patient. Ann Surg. 1996 Nov;224(5):598-602. doi: 10.1097/00000658-199611000-00003.
PubMed 8916874Bay-Nielsen M, Perkins FM, Kehlet H; Danish Hernia Database. Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Ann Surg. 2001 Jan;233(1):1-7. doi: 10.1097/00000658-200101000-00001.
PubMed 11141218Laparoscopic versus open repair of groin hernia: a randomised comparison. The MRC Laparoscopic Groin Hernia Trial Group. Lancet. 1999 Jul 17;354(9174):185-90.
PubMed 10421299Katkhouda N, Mavor E, Friedlander MH, Mason RJ, Kiyabu M, Grant SW, Achanta K, Kirkman EL, Narayanan K, Essani R. Use of fibrin sealant for prosthetic mesh fixation in laparoscopic extraperitoneal inguinal hernia repair. Ann Surg. 2001 Jan;233(1):18-25. doi: 10.1097/00000658-200101000-00004.
PubMed 11141220Jourdan IC, Bailey ME. Initial experience with the use of N-butyl 2-cyanoacrylate glue for the fixation of polypropylene mesh in laparoscopic hernia repair. Surg Laparosc Endosc. 1998 Aug;8(4):291-3.
PubMed 9703604Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350(18):1819-27. doi: 10.1056/NEJMoa040093. Epub 2004 Apr 25.
PubMed 15107485Bittner R, Schmedt CG, Schwarz J, Kraft K, Leibl BJ. Laparoscopic transperitoneal procedure for routine repair of groin hernia. Br J Surg. 2002 Aug;89(8):1062-6. doi: 10.1046/j.1365-2168.2002.02178.x.
PubMed 12153636
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stapler Versus Glue for Laparoscopic Groin Hernia Repair
- ClinicalTrials.gov ID
- NCT00793286
- Acronym / sponsor ID
- KEK_89_04
- Conditions
- Inguinal Hernia, Recurrence, Pain
- Keywords
- inguinal hernia, laparoscopy, mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Aug 2004
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 19 Nov 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.
Repair of inguinal hernia is the most common operation of the general surgeon. In recent years, it was recognized that chronic postoperative pain is as important for postoperative outcome as recurrent hernia. The incidence of pain or discomfort ranges up to 60% of operated patients. Despite the fact that laparoscopic hernia repair has been shown to reduce postoperative pain compared to open hernia repair, up to 5% of patients suffer from persistent discomfort. During that operation the mesh is either fixed using a stapler or tissue adhesive glue. With the current study we compare postoperative pain between patients undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high sensitivity.
Detailed description
Despite the fact that laparoscopic hernia repair has been shown to reduce postoperative pain compared to open hernia repair, up to 5% of patients suffer from persistent discomfort. During that operation the mesh is either fixed using a stapler or tissue adhesive glue. With the current study we compare postoperative pain between patients undergoing laparoscopic inguinal hernia repair with either mesh fixation using a stapler or tissue adhesive. The use of von Frey monofilaments allows to describe pain with a high sensitivity.
To perform a prospective randomized trial comparing pain after inguinal hernia repair using either fixation with stapler or histoacryl.
The standard TAPP procedure is performed under general anesthesia. Patients receive a single shot antibiotic prophylaxis, using Amoxicillin/Clavulanic Acids. Operations are performed by resident surgeons under supervision, consultants or senior consultants. After hernial sac dissection and retraction, preperitoneal fat is removed bluntly and Cooper's ligament is identified. A Vypro II ® (Ethicon ®) prosthetic mesh, 10x15 cm, is placed and fixed depending on randomization with either 5 mm Protack TM (Autosuture TM) or Glubran ® 2 (G.E.M., Viareggio, Italy). Randomization is performed in permutated block of 20 using sealed envelopes. Where tissue glue is used, meshs are additionally fixed caudally and laterocaudally. Peritoneal closure over the mesh is performed using resorptive sutures. Glubran ® 2 is a cyanoacrylate tissue adhesive. Follow up assessment: The use of analgesics in the postoperative period is standardized using paracetamol and morphine derivates. Following discharge patients are liberated of physical restrictions. Patient follow-up will be performed after 6 weeks, 6 and 12 months postoperatively. Patients are advised to mention pain in the operated groin area. In addition the Visual Analogue Scale is used to evaluate pain intensity.Statistical comparison is done using Mann-Whitney Test and Chi square Test (significance p < 0,05).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Other | Procedure: Mesh fixation by staplesMesh fixation by staples |
| B | Other | Procedure: Mesh fixation by glueMesh fixation by glue |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- patients scheduled for laparoscopic primary inguinal hernia repair
- uni- or bilateral patients with recurrent hernias after anterior surgical technique
- written informed consent
Key exclusion criteria (1 listed)
- general contradictions for laparoscopy
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 |
|---|---|---|
| Mesh fixation by staplesMesh fixation by staples | Procedure or surgery | A |
| Mesh fixation by glueAlso: N-Butyl-2 Cyanoacrulat GlueMesh fixation by glue | Procedure or surgery | B |
Primary outcome
Recurrence
Time frame: 6 weeks, 6 months, 12 months postoperative
3 secondary outcomes
postoperative pain
Time frame: 6 weeks, 6 months, 12 months postoperative
sensibility disorder
Time frame: 6 weeks, 6 months, 12 months postoperative
intra- and postoperative complications
Time frame: 6 weeks, 6 months, 12 months postoperative
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 24 Nov 2008.
- Background: PubMed 12535413McCormack K, Scott NW, Go PM, Ross S, Grant AM; EU Hernia Trialists Collaboration. Laparoscopic techniques versus open techniques for inguinal hernia repair. Cochrane Database Syst Rev. 2003;2003(1):CD001785. doi: 10.1002/14651858.CD001785.
- Background: PubMed 8916874Cunningham J, Temple WJ, Mitchell P, Nixon JA, Preshaw RM, Hagen NA. Cooperative hernia study. Pain in the postrepair patient. Ann Surg. 1996 Nov;224(5):598-602. doi: 10.1097/00000658-199611000-00003.
- Background: PubMed 11141218Bay-Nielsen M, Perkins FM, Kehlet H; Danish Hernia Database. Pain and functional impairment 1 year after inguinal herniorrhaphy: a nationwide questionnaire study. Ann Surg. 2001 Jan;233(1):1-7. doi: 10.1097/00000658-200101000-00001.
- Background: PubMed 10421299Laparoscopic versus open repair of groin hernia: a randomised comparison. The MRC Laparoscopic Groin Hernia Trial Group. Lancet. 1999 Jul 17;354(9174):185-90.
- Background: PubMed 11141220Katkhouda N, Mavor E, Friedlander MH, Mason RJ, Kiyabu M, Grant SW, Achanta K, Kirkman EL, Narayanan K, Essani R. Use of fibrin sealant for prosthetic mesh fixation in laparoscopic extraperitoneal inguinal hernia repair. Ann Surg. 2001 Jan;233(1):18-25. doi: 10.1097/00000658-200101000-00004.
- Background: PubMed 9703604Jourdan IC, Bailey ME. Initial experience with the use of N-butyl 2-cyanoacrylate glue for the fixation of polypropylene mesh in laparoscopic hernia repair. Surg Laparosc Endosc. 1998 Aug;8(4):291-3.
- Background: PubMed 15107485Neumayer L, Giobbie-Hurder A, Jonasson O, Fitzgibbons R Jr, Dunlop D, Gibbs J, Reda D, Henderson W; Veterans Affairs Cooperative Studies Program 456 Investigators. Open mesh versus laparoscopic mesh repair of inguinal hernia. N Engl J Med. 2004 Apr 29;350(18):1819-27. doi: 10.1056/NEJMoa040093. Epub 2004 Apr 25.
- Background: PubMed 12153636Bittner R, Schmedt CG, Schwarz J, Kraft K, Leibl BJ. Laparoscopic transperitoneal procedure for routine repair of groin hernia. Br J Surg. 2002 Aug;89(8):1062-6. doi: 10.1046/j.1365-2168.2002.02178.x.
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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.
Guido Beldi, MD principal investigator
Dep. of Visceral and Transplantsurgery, Bern University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesh fixation by staples and Mesh fixation by glue in people with Inguinal Hernia and Recurrence, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
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 1 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 24 Nov 2008. 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 Switzerland. 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?
Recurrence (time frame: 6 weeks, 6 months, 12 months postoperative). 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 NCT00793286, which also lists 8 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 24 Nov 2008.