The Effect of Mesh Fixation Technique on Postoperative Pain in Laparoscopic Correction of Incisional and Ventral Abdominal Wall Hernias.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 215
- Locations
- 2
- Primary Endpoint
- Assessment of postoperative pain
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
- •Peritoneal dialysis
- •Current abdominal infection
- •Complete loss of abdominal domain due to hernia (diameter more than 10 cm?)
- •Re-laparoscopic correction of ventral hernia
Outcomes
Primary Outcomes
Assessment of postoperative pain
Time Frame: one year
Secondary Outcomes
- Quality of life(one year)
- Overall satisfaction(one year)
- Postoperative stay(one month)
- Per- and postoperative morbidity(one month)
- Recurrence(Three years)