Mesh versus patch for hernia epigastrica and umbilical repair. A multicenter patient-blinded randomized trial.

Mesh versus patch for hernia epigastrica and umbilical repair. A multicenter patient-blinded randomized trial. - MORHPEUS Mesh OR Patch for Hernia on Epigastric and Umbilical Sites

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON39471

Enrollment

346

Registered

2010-11-18

Start date

2011-01-03

Completion date

Unknown

Last updated

2024-06-24

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

Conditions

buikwandbreuken Umbilical and epigastric hernia

Interventions

All procedures will be performed under general anesthesia. Addition of lokal anestheticum is advocated. Profylactic antibiotics only on indication. Use of drapes or drains is not advocated. Enlargin

opening hernia sac, ensuring no adhesions at peritoneum. Placing patch against abdominal waal. Fixation to fascia. Standard mesh is PROCEED tm VENTRAL PATCH (Ethicon, Norderstedt, Germany).

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - single primary umbilical or epigastric hernia - size less than 3 cm (2 fingers)

Exclusion criteria

Exclusion criteria: - age

Design outcomes

Primary

Measure	Time frame
Primary endpoint is number of complications. A complication is defined as unexpected event related to the operation field which necessitates a treatment within 3 months postoperatievly. Treatment can be initiated by primar as well as general physician. These includes - peroperative bleeding or other damage - prescribed medication such as antibiotics and analgesics after discharge other than paracetamol - re-intervention for haematoma, abccess drainage, exploration due to pain / early recurrence / intra-abdominal problems - woundcare at least the equivalent of rinsing once a day - hospital stay longer than expected or re-admission for observation	—

Measure

Time frame

Primary endpoint is number of complications. A complication is defined as unexpected event related to the operation field which necessitates a treatment within 3 months postoperatievly. Treatment can be initiated by primar as well as general physician. These includes - peroperative bleeding or other damage - prescribed medication such as antibiotics and analgesics after discharge other than paracetamol - re-intervention for haematoma, abccess drainage, exploration due to pain / early recurrence / intra-abdominal problems - woundcare at least the equivalent of rinsing once a day - hospital stay longer than expected or re-admission for observation

—

Secondary

Measure	Time frame
Pre-operative Length, weigth, Verbal Descriptor Scale (VDS) pain at rest, during excercise, VDS cosmetics, intensity of daily activities/work Per-operative Randomized device, incarceration, resection hernia sac, diameter hernia, enlargment hernia, closure of fascia, presence of adhesions, operation duration, VDS ease procedure, complications, reason for protocol deviations Postoperative Complications, Verbal Descriptor Scale (VDS) pain at rest, during excercise, VDS cosmetics, recurrence, Costs Post-hoc computing based on number of vistis, operation duration, device and complications related costs up to 2 years postoperatively.	—

Measure

Time frame

Pre-operative Length, weigth, Verbal Descriptor Scale (VDS) pain at rest, during excercise, VDS cosmetics, intensity of daily activities/work Per-operative Randomized device, incarceration, resection hernia sac, diameter hernia, enlargment hernia, closure of fascia, presence of adhesions, operation duration, VDS ease procedure, complications, reason for protocol deviations Postoperative Complications, Verbal Descriptor Scale (VDS) pain at rest, during excercise, VDS cosmetics, recurrence, Costs Post-hoc computing based on number of vistis, operation duration, device and complications related costs up to 2 years postoperatively.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)