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.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON19969

Enrollment

950

Registered

2009-12-03

Start date

2010-01-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

(Endoscopic) hernia repair surgery/ (endoscopische) liesbreukchirurgie Chronic pain/ Chronische pijnklachten

Interventions

Arm 1 (intervention group): lightweight mesh (Ultrapro): 50% of participants will be randomized to receive this mesh. Mesh characteristics are: 1. Structure: Multifilament with large pores (3-4 mm)

2. Polymer fiber: Polypropylene (PP) + Monocryl component (Poliglecapron)

3. Weight: 28 g/m2 (part of polypropylene which is not absorbed). The monocryl part (polyglecapron) is absorbed in 90-120 days due to hydrolysis

a lightweight mesh with a pore size of 3-4 mm is what remains. Arm 2 (Control group): heavyweight mesh (Prolene): The heavyweight mesh Prolene® is the standard used at a TEP hernia repair in the Her

2. Polymer fiber: Polypropyleen

3. Weight: 80-85 g/m2.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male patients; 2. ≥ 18 year old; 3. Primary, unilateral, symptomatic, reducible hernia; 4. Totally Extraperitoneal (TEP) endoscopic hernia repair.

Exclusion criteria

Exclusion criteria: 1. Bilateral hernia; 2. Scrotal hernia; 3. Recurrent hernia; 4. Walking distance < 500 m; 5. Collagen disorders, such as Marfan Syndrome; 6. 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).

Design outcomes

Primary

Measure	Time frame
Frequency of chronic pain after Totally Extraperitoneal (TEP) endoscopic hernia repair.	—

Secondary

Measure	Time frame
1. Recurrene Rate; 2. Mesh ‘feeling’; 3. Sensitivity disorders (such as hypo- or hyperaesthesia); 4. Sexual functioning related to pain; 5. Postoperative complications (such as wound infection/hematoma/urinary tract infection/hydrocele etc.); 6. Time to postoperative recovery (return to work and daily activities); 7. Occurrence of long-term complications (e.g. testicular atrofia).	—

Contacts

Public ContactN. Schouten

Prof. Lorentzlaan 76

nelleke.schouten@gmail.com+31 (0)30 6989214

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)