Clinical trial NCT00537927: LACH-Trial: LAparoscopic Correction of Hernia
Official title: The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Incisional Hernia
Ventral Hernia
Keywords: laparoscopic correction
ventral and incisional hernia
mesh fixation
postoperative pain
Lead sponsor: Ziekenhuisgroep Twente
Sponsor class: OTHER
First posted: 2007-10-02
Enrollment: 215
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Assessment of postoperative pain
timeFrame: one year
Secondary outcomes:
measure: Quality of life
timeFrame: one year
measure: Overall satisfaction
timeFrame: one year
measure: Postoperative stay
timeFrame: one month
measure: Per- and postoperative morbidity
timeFrame: one month
measure: Recurrence
timeFrame: Three years
Other outcomes:
Locations:
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
Study officials:
affiliation: Ziekenhuisgroep Twente
name: Eelco B Wassenaar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ziekenhuisgroep Twente
name: Srjdan Rakic, MD, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.