MedDataX Logo

Stapler Versus Glue for Laparoscopic Groin Hernia Repair

NCT ID: NCT00793286

Last Updated: 2008-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2008-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Inguinal Hernia Recurrence Pain

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

inguinal hernia laparoscopy mesh

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

A

Mesh fixation by staples

Group Type OTHER

Mesh fixation by staples

Intervention Type PROCEDURE

Mesh fixation by staples

B

Mesh fixation by glue

Group Type OTHER

Mesh fixation by glue

Intervention Type PROCEDURE

Mesh fixation by glue

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mesh fixation by staples

Mesh fixation by staples

Intervention Type PROCEDURE

Mesh fixation by glue

Mesh fixation by glue

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

N-Butyl-2 Cyanoacrulat Glue

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* patients scheduled for laparoscopic primary inguinal hernia repair
* uni- or bilateral patients with recurrent hernias after anterior surgical technique
* written informed consent

Exclusion Criteria

* general contradictions for laparoscopy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Dep. of Visceral and Transplantsurgery, Bern University Hospital

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Guido Beldi, MD

Role: PRINCIPAL_INVESTIGATOR

Dep. of Visceral and Transplantsurgery, Bern University Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dep. of Visceral and Transplantsurgery, Bern University Hospital

Bern, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 12535413 (View on PubMed)

Cunningham 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.

Reference Type BACKGROUND
PMID: 8916874 (View on PubMed)

Bay-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.

Reference Type BACKGROUND
PMID: 11141218 (View on PubMed)

Laparoscopic versus open repair of groin hernia: a randomised comparison. The MRC Laparoscopic Groin Hernia Trial Group. Lancet. 1999 Jul 17;354(9174):185-90.

Reference Type BACKGROUND
PMID: 10421299 (View on PubMed)

Katkhouda 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.

Reference Type BACKGROUND
PMID: 11141220 (View on PubMed)

Jourdan 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.

Reference Type BACKGROUND
PMID: 9703604 (View on PubMed)

Neumayer 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.

Reference Type BACKGROUND
PMID: 15107485 (View on PubMed)

Bittner 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.

Reference Type BACKGROUND
PMID: 12153636 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KEK_89_04

Identifier Type: -

Identifier Source: org_study_id