LACH-Trial: LAparoscopic Correction of Hernia

This study has been completed.

Sponsor:

Information provided by:

Ziekenhuisgroep Twente

ClinicalTrials.gov Identifier:

NCT00537927

First received: October 1, 2007

Last updated: February 17, 2009

Last verified: January 2009

History of Changes

Tracking Information

First Received Date ^ICMJE

October 1, 2007

Last Updated Date

February 17, 2009

Start Date ^ICMJE

August 2005

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00537927 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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 ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

LACH-Trial: LAparoscopic Correction of Hernia

Official Title ^ICMJE

The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.

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.

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Condition ^ICMJE

Incisional Hernia
Ventral Hernia

Intervention ^ICMJE

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

Study Arm (s)

Active Comparator: 0
fixation of mesh with a single crown of tacks and absorbable sutures

Intervention: Procedure: laparoscopic correction of hernia with mesh
Active Comparator: 1
fixation of mesh with a double crown of tacks and no sutures

Intervention: Procedure: laparoscopic correction of hernia with mesh
Active Comparator: 2
fixation of mesh with a single crown of tacks and non-absorbable sutures

Intervention: Procedure: laparoscopic correction of hernia with mesh

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

215

Completion Date

January 2009

Primary Completion Date

October 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Netherlands

Administrative Information

NCT Number ^ICMJE

NCT00537927

Other Study ID Numbers ^ICMJE

P05-28

Has Data Monitoring Committee

Yes

Responsible Party

EB Wassenaar, MD, Ziekenhuisgroep Twente

Study Sponsor ^ICMJE

Ziekenhuisgroep Twente

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

Information Provided By

Ziekenhuisgroep Twente

Verification Date

January 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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