LACH-Trial: LAparoscopic Correction of Hernia - Full Text View

Purpose

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.

Condition	Intervention
Incisional Hernia Ventral Hernia	Procedure: laparoscopic correction of hernia with mesh

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Treatment
Official Title:	The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.

Resource links provided by NLM:

Genetics Home Reference related topics: abdominal wall defect

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by Ziekenhuisgroep Twente:

Primary Outcome Measures:

Assessment of postoperative pain [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quality of life [ Time Frame: one year ] [ Designated as safety issue: No ]
Overall satisfaction [ Time Frame: one year ] [ Designated as safety issue: No ]
Postoperative stay [ Time Frame: one month ] [ Designated as safety issue: No ]
Per- and postoperative morbidity [ Time Frame: one month ] [ Designated as safety issue: No ]
Recurrence [ Time Frame: Three years ] [ Designated as safety issue: No ]

Enrollment:	215
Study Start Date:	August 2005
Study Completion Date:	January 2009
Primary Completion Date:	October 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 0 fixation of mesh with a single crown of tacks and absorbable sutures	Procedure: laparoscopic correction of hernia with mesh Correction of hernia with mesh and fixation of mesh using one of the arms. Other Names: DualMesh Mersilene Vicryl ProTack Suture Passer
Active Comparator: 1 fixation of mesh with a double crown of tacks and no sutures	Procedure: laparoscopic correction of hernia with mesh Correction of hernia with mesh and fixation of mesh using one of the arms. Other Names: DualMesh Mersilene Vicryl ProTack Suture Passer
Active Comparator: 2 fixation of mesh with a single crown of tacks and non-absorbable sutures	Procedure: laparoscopic correction of hernia with mesh Correction of hernia with mesh and fixation of mesh using one of the arms. Other Names: DualMesh Mersilene Vicryl ProTack Suture Passer

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

< 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537927

Locations

Netherlands
Ziekenhuisgroep Twente
Almelo, Netherlands, 7600 SZ

Sponsors and Collaborators

Ziekenhuisgroep Twente

Investigators

Principal Investigator:	Eelco B Wassenaar, MD	Ziekenhuisgroep Twente
Study Director:	Srjdan Rakic, MD, PhD	Ziekenhuisgroep Twente

More Information

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.

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.

LeBlanc KA. Laparoscopic incisional and ventral hernia repair: complications-how to avoid and handle. Hernia. 2004 Dec;8(4):323-31. Review.

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.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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. Epub 2009 Dec 24.

Responsible Party:	EB Wassenaar, MD, Ziekenhuisgroep Twente
ClinicalTrials.gov Identifier:	NCT00537927 History of Changes
Other Study ID Numbers:	P05-28
Study First Received:	October 1, 2007
Last Updated:	February 17, 2009
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Ziekenhuisgroep Twente:

laparoscopic correction
ventral and incisional hernia
mesh fixation
postoperative pain

Additional relevant MeSH terms:

Hernia
Hernia, Ventral
Pain, Postoperative
Pathological Conditions, Anatomical
Hernia, Abdominal

Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013