LACH-Trial: LAparoscopic Correction of Hernia

Ventral Hernia Clinical Trial

— LACH  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00537927
• Other study ID #: P05-28
• Status: Completed
• Phase: N/A
• First received: October 1, 2007
• Last updated: February 17, 2009
• Start date: August 2005
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Ziekenhuisgroep Twente
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: Medical Ethics Review Committee (METC)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: January 2009
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hernia
• Hernia, Ventral
• Incisional Hernia
• Ventral Hernia

Intervention

Procedure:
• laparoscopic correction of hernia with mesh
Correction of hernia with mesh and fixation of mesh using one of the arms.

Locations

Country	Name	City	State
Netherlands	Ziekenhuisgroep Twente	Almelo

Sponsors (1)

Lead Sponsor	Collaborator
Ziekenhuisgroep Twente

Country where clinical trial is conducted

Netherlands, 

References & Publications (4)

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. — View 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. — View 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. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of postoperative pain		one year	No
Secondary	Quality of life		one year	No
Secondary	Overall satisfaction		one year	No
Secondary	Postoperative stay		one month	No
Secondary	Per- and postoperative morbidity		one month	No
Secondary	Recurrence		Three years	No