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Long Term Follow-up PRIMA Trial

Long term Follow-up of Primary Mesh Closure of Abdominal Midline Wounds, a double blind Randomized Controlled Tria

Status
Active, not recruiting
Phases
Unknown
Study type
Unknown
Source
NL-OMON
Registry ID
NL-OMON22792
Enrollment
350
Registered
2018-05-01
Start date
2018-07-19
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Incisional hernia

Interventions

Follow-up: physical examination and ultrasonography

Sponsors

Prof. dr. J.M. Hendriks Department of Surgery Erasmus MC, Rotterdam j.m.hendriks@erasmusmc.nl
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Participated in the PRIMA trial • Signed informed consent

Exclusion criteria

Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Pregnancy during follow up • Subjects who underwent re-operation (midline abdominal surgery)

Design outcomes

Primary

MeasureTime frame
The primary outcome will be IH incidence up to five years after surgery, clinically and/or radiologically detected.—

Secondary

MeasureTime frame
Secondary outcomes will comprise: • Hernia repair surgery o Size of hernia o Type of mesh fixation • Symptomatic IH; o Pain or discomfort at the site of the scar o Incarceration of the bowel o Aesthetic symptoms • IH progression (assessed with ultrasonography or CT-scan) • Cost-benefit analysis (direct costs) o General practitioner visits o Emergency department visits o Radiological examinations o Outpatient clinic visits o Hospitalization—

Contacts

Public ContactJ.F. Lange

Erasmus Medical Center, Department of Surgery, P.O.Box 2040

j.lange@erasmusmc.nl+31 (0)10 4634593

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)