No registrations found.
ID
Source
Brief title
Health condition
Incisional hernia
Sponsors and support
Department of Surgery
Erasmus MC, Rotterdam
j.m.hendriks@erasmusmc.nl
Intervention
Outcome measures
Primary outcome
The primary outcome will be IH incidence up to five years after surgery, clinically and/or radiologically detected.
Secondary outcome
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
Background summary
Rationale: Onlay and sublay mesh reinforcement after midline laparotomies in patients with an increased risk for the development of incisional hernias (IHs) resulted in less IHs compared to patients that received the conventional closure technique at two years follow up.
Objective: The main objective of this long-term follow up study is to investigate IH incidence after closure of midline incisions in the three existing study groups (primary suture closure, onlay mesh reinforcement and sublay mesh reinforcement).
Study design: In the LTFU PRIMA trial, patients who were initially included will receive one additional follow-up examination. The PRIMA trial was designed as double blinded randomized controlled trial.
Study population: Subjects included in the PRIMA-trial will be asked to participate. In the PRIMA trial patients with an increased risk for the development of IHs are included. Intervention (if applicable): In the LTFU PRIMA-trial patients included subjects will not undergo additional interventions. They will be invited to the outpatient clinic where they will undergo a physical examination and if agreed upon an ultrasonography of the post-operative scar.
Main study parameters/endpoints: Primary outcome will be IH incidence in high-risk groups after midline laparotomy, after a follow-up of five years Secondary outcomes comprise: IH repair surgery, symptomatic IH, IH progression and cost-benefit.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Patients will be invited to visit the outpatient clinic once. During this visit physical examination and an ultrasonography will be performed.
Study objective
Onlay and sublay mesh reinforcement after midline laparotomies in patients with an increased risk for the development of incisional hernias (IHs) resulted in less IHs compared to patients that received the conventional closure technique at two years follow up.
The main objective of this long-term follow up study is to investigate IH incidence after closure of midline incisions in the three existing study groups (primary suture closure, onlay mesh reinforcement and sublay mesh reinforcement).
Study design
5 years after surgery
Intervention
Follow-up: physical examination and ultrasonography
P.O.Box 2040
J.F. Lange
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634593
j.lange@erasmusmc.nl
P.O.Box 2040
J.F. Lange
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634593
j.lange@erasmusmc.nl
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
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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7176 |
| NTR-old | NTR7367 |
| Other | Erasmus MC : mec20181040 |