How to prevent the trocar-site hernia? A totally atraumatic endoscopic mini-IPOM-Plug technique (with extra-lightweight titanium coated mesh and glue)

Prevention of the trocar-site hernia with prophylactic mesh: a randomized clinical trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN67377966

Enrollment

100

Registered

2015-12-01

Start date

2015-01-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Trocar-site hernia Digestive System

Interventions

Patients were randomized on the day of surgery to receive either a prophylactic mesh in the umbilical trocar site (treatment group) or no treatment in the umbilical site (no treatment - control group)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients undergoing surgery for symptomatic cholelitiasis 2. Age range 20-70 years 3. Male and female 4. American Society of Anesthesiology (ASA) classification of 3 or less 5. No co-morbidity cardiopulmonary, hepatic or renal impairment 6. Consent was given for surgery

Exclusion criteria

Exclusion criteria: 1. Patients with ASA higher than 3 2. Current malignant diseases 3. Proven mental illness or other circumstances that might compromise the patient’s cooperation in addition to those who refused to give informed consent

Design outcomes

Primary

Measure	Time frame
Recurrence rate at 1 year	—

Secondary

Measure	Time frame
1. Operative time 2. Morbidity (infection, seroma or chronic pain) at 1 month and 3 months	—

Countries

Spain

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026