LACH-Trial: LAparoscopic Correction of Hernia

NCT00537927 | Completed DMC

• 1 other identifier: P05-28
• Study Type: interventional
• Target: 215
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Incisional Hernia; Ventral Hernia

Keywords

laparoscopic correction; ventral and incisional hernia; mesh fixation; postoperative pain

Outcome Measures

Primary Outcomes (1)

• Assessment of postoperative pain

  one year

Secondary Outcomes (5)

• Quality of life

  one year

• Overall satisfaction

  one year

• Postoperative stay

  one month

• Per- and postoperative morbidity

  one month

• Recurrence

  Three years

Study Arms (3)

0

ACTIVE COMPARATOR

fixation of mesh with a single crown of tacks and absorbable sutures

Procedure: laparoscopic correction of hernia with mesh

1

ACTIVE COMPARATOR

fixation of mesh with a double crown of tacks and no sutures

Procedure: laparoscopic correction of hernia with mesh

2

ACTIVE COMPARATOR

fixation of mesh with a single crown of tacks and non-absorbable sutures

Procedure: laparoscopic correction of hernia with mesh

Interventions

laparoscopic correction of hernia with mesh PROCEDURE

Correction of hernia with mesh and fixation of mesh using one of the arms.

Also known as: DualMesh, Mersilene, Vicryl, ProTack, Suture Passer

0; 1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-acute incisional hernia of the abdominal wall or ventral hernia of the abdominal wall
• Informed consent
• Elective surgery

You may not qualify if:

• \< 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

Sponsors & Collaborators

• Ziekenhuisgroep Twente: lead

Study Sites (1)

Ziekenhuisgroep Twente

Almelo, 7600 SZ, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 12361426 BACKGROUND

• DeMaria 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.

  PMID: 10790548 BACKGROUND

• LeBlanc 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.

  PMID: 15235939 BACKGROUND

• Heniford 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.

  PMID: 14501505 BACKGROUND

• Wassenaar 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.

  PMID: 20033726 DERIVED

MeSH Terms

Conditions

Incisional Hernia; Hernia, Ventral; Pain, Postoperative

Interventions

Melanocyte-Stimulating Hormones; Lavsan; Polyglactin 910

Condition Hierarchy (Ancestors)

Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Hernia, Abdominal; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Melanocortins; Pro-Opiomelanocortin; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Pituitary Hormones, Anterior; Pituitary Hormones; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins; Polyesters; Polymers; Macromolecular Substances; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Eelco B Wassenaar, MD

  Ziekenhuisgroep Twente

  PRINCIPAL INVESTIGATOR

• Srjdan Rakic, MD, PhD

  Ziekenhuisgroep Twente

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 1, 2007
• First Posted: October 2, 2007
• Study Start: August 1, 2005
• Primary Completion: October 1, 2008
• Study Completion: January 1, 2009
• Last Updated: February 18, 2009

Record last verified: 2009-01

Locations

NL (1)