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

Sponsored by:	Ziekenhuisgroep Twente
Information provided by:	Ziekenhuisgroep Twente
ClinicalTrials.gov Identifier:	NCT00537927

Purpose

Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair does not influence the degree of postoperative pain.

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

MedlinePlus related topics: Hernia

U.S. FDA Resources

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

Further study details as provided by Ziekenhuisgroep Twente:

Primary Outcome Measures:

Assessment of postoperative pain [ Time Frame: one year ]
Time to recurrence [ Time Frame: three years ]

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	200
Study Start Date:	August 2005
Estimated Study Completion Date:	October 2008

Arms	Assigned Interventions
0 fixation of mesh with a single crown of tacks and absorbable sutures	Procedure: laparoscopic correction of hernia with mesh
1 fixation of mesh with a double crown of tacks and no sutures	Procedure: laparoscopic correction of hernia with mesh
2 fixation of mesh with a single crown of tacks and non-absorbable sutures	Procedure: laparoscopic correction of hernia with mesh

Detailed Description:

Method of fixation of the mesh in laparoscopic incisional / ventral hernia repair does not influence the degree of postoperative pain. It can influence other outcome parameters such as return to preoperative activities, costs and recurrence rate.

There is no difference in postoperative pain between the three methods of fixation.

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

Contacts

Contact: Eelco B Wassenaar, MD	+31 6 28787728	ebwassenaar@tiscali.nl
Contact: Srdjan Rakic, MD, PhD	+31 546 693693	s.rakic@zgt.nl

Locations

Netherlands
Ziekenhuisgroep Twente	Recruiting
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.

Study ID Numbers:	P05-28
Study First Received:	October 1, 2007
Last Updated:	October 1, 2007
ClinicalTrials.gov Identifier:	NCT00537927
Health Authority:	Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by Ziekenhuisgroep Twente:

laparoscopic correction
ventral and incisional hernia
mesh fixation
postoperative pain

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hernia
Hernia, Abdominal

Hernia, Ventral
Pain
Pain, Postoperative

ClinicalTrials.gov processed this record on January 15, 2009