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OpenTrials
Completed

NCT Number: NCT00537927

LACH-Trial: LAparoscopic Correction of Hernia

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.

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Key information

Conditions

Incisional Hernia Hernia Hernia, Abdominal Hernia, Ventral Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Ventral Hernia

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ziekenhuisgroep Twente

Almelo, 7600 SZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laparoscopic correction of hernia with mesh

Procedure

Correction of hernia with mesh and fixation of mesh using one of the arms.

Other names: DualMesh, Mersilene, Vicryl, ProTack, Suture Passer

Primary outcomes

  1. Assessment of postoperative pain

    Time frame: one year

Secondary outcomes

  1. Quality of life

    Time frame: one year

  2. Overall satisfaction

    Time frame: one year

  3. Postoperative stay

    Time frame: one month

  4. Per- and postoperative morbidity

    Time frame: one month

  5. Recurrence

    Time frame: Three years

Sponsors and collaborators

Lead sponsor

Ziekenhuisgroep Twente

Other

Registry information

Official study title

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

Acronym: LACH

Important dates

Study start
2005
Primary completion
2008
Study completion
2009
First posted
Oct 2, 2007
Registry last updated
Feb 18, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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