THE EFFECT OF MESH TYPE (ULTRAPRO VERSUS PROLENE) ON POSTOPERATIVE PAIN AND WELL-BEING FOLLOWING TOTALLY EXTRAPERITONEAL (TEP) LAPAROSCOPIC HERNIA REPAIR: A RANDOMIZED CONTROLLED TRIAL.

Completed

Conditions: liesbreuken
groin hernia
inguinal hernia
10043413

Registration Number: NL-OMON38149

Lead Sponsor: Diakonessenhuis Utrecht

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 950

Inclusion Criteria

Male patients
>= 18 year old
Primary, unilateral, symptomatic, reducible hernia
Totally Extraperitoneal (TEP) endoscopic hernia repair

Exclusion Criteria

Bilateral hernia
Scrotal hernia
Recurrent hernia
Walking distance < 500 m.
Collagen disorders, such as Marfan Syndrome
Likely problems, in the judgment of the investigators, with maintaining follow-up
(e.g., patients with no fixed address or insufficient comprehension of
Dutch language will be excluded).

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Frequency of chronic pain 3 months after Totally Extraperitoneal (TEP)<br /><br>endoscopic hernia repair. For the primary study outcome the Definition of the<br /><br>International Association for the Study of Pain' is used, in which chronic pain<br /><br>is defined as pain 'still present 3 months after the operation'.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Secondary objectives are: Frequency of early postoperative pain (1 week after<br /><br>surgery), pain at 6 weeks, 1 year, 2 year and 3 year.<br /><br>Recurrene Rate, Mesh feeling, Sensitivity disorders (such as hypo- or<br /><br>hyperaesthesia), Sexual functioning related to pain, Postoperative<br /><br>complications (such as wound infection/hematoma/urinary tract<br /><br>infection/hydrocele etc.), Time to postoperative recovery (return to work and<br /><br>daily activities), Occurrence of long-term complications (e.g. testicular<br /><br>atrofia). </p><br>