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LACH-Trial: LAparoscopic Correction of Hernia (LACH)

Primary Purpose

Incisional Hernia, Ventral Hernia

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
laparoscopic correction of hernia with mesh
Sponsored by
Ziekenhuisgroep Twente
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incisional Hernia focused on measuring laparoscopic correction, ventral and incisional hernia, mesh fixation, postoperative pain

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ziekenhuisgroep Twente

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

0

1

2

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Assessment of postoperative pain

Secondary Outcome Measures

Quality of life
Overall satisfaction
Postoperative stay
Per- and postoperative morbidity
Recurrence

Full Information

First Posted
October 1, 2007
Last Updated
February 17, 2009
Sponsor
Ziekenhuisgroep Twente
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1. Study Identification

Unique Protocol Identification Number
NCT00537927
Brief Title
LACH-Trial: LAparoscopic Correction of Hernia
Acronym
LACH
Official Title
The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2009
Overall Recruitment Status
Completed
Study Start Date
August 2005 (undefined)
Primary Completion Date
October 2008 (Actual)
Study Completion Date
January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ziekenhuisgroep Twente

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Incisional Hernia, Ventral Hernia
Keywords
laparoscopic correction, ventral and incisional hernia, mesh fixation, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
215 (Actual)

8. Arms, Groups, and Interventions

Arm Title
0
Arm Type
Active Comparator
Arm Description
fixation of mesh with a single crown of tacks and absorbable sutures
Arm Title
1
Arm Type
Active Comparator
Arm Description
fixation of mesh with a double crown of tacks and no sutures
Arm Title
2
Arm Type
Active Comparator
Arm Description
fixation of mesh with a single crown of tacks and non-absorbable sutures
Intervention Type
Procedure
Intervention Name(s)
laparoscopic correction of hernia with mesh
Other Intervention Name(s)
DualMesh, Mersilene, Vicryl, ProTack, Suture Passer
Intervention Description
Correction of hernia with mesh and fixation of mesh using one of the arms.
Primary Outcome Measure Information:
Title
Assessment of postoperative pain
Time Frame
one year
Secondary Outcome Measure Information:
Title
Quality of life
Time Frame
one year
Title
Overall satisfaction
Time Frame
one year
Title
Postoperative stay
Time Frame
one month
Title
Per- and postoperative morbidity
Time Frame
one month
Title
Recurrence
Time Frame
Three years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eelco B Wassenaar, MD
Organizational Affiliation
Ziekenhuisgroep Twente
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Srjdan Rakic, MD, PhD
Organizational Affiliation
Ziekenhuisgroep Twente
Official's Role
Study Director
Facility Information:
Facility Name
Ziekenhuisgroep Twente
City
Almelo
ZIP/Postal Code
7600 SZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
12361426
Citation
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.
Results Reference
background
PubMed Identifier
10790548
Citation
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.
Results Reference
background
PubMed Identifier
15235939
Citation
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.
Results Reference
background
PubMed Identifier
14501505
Citation
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.
Results Reference
background
PubMed Identifier
20033726
Citation
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.
Results Reference
derived

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LACH-Trial: LAparoscopic Correction of Hernia

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