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…
ID
Bron
Verkorte titel
Aandoening
Incisional hernia
Ondersteuning
Department of Surgery
Erasmus MC, Rotterdam
j.m.hendriks@erasmusmc.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The primary outcome will be IH incidence up to five years after surgery, clinically and/or radiologically detected.
Achtergrond van het onderzoek
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.
Doel van het onderzoek
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).
Onderzoeksopzet
5 years after surgery
Onderzoeksproduct en/of interventie
Follow-up: physical examination and ultrasonography
Publiek
P.O.Box 2040
J.F. Lange
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634593
j.lange@erasmusmc.nl
Wetenschappelijk
P.O.Box 2040
J.F. Lange
Rotterdam 3000 CA
The Netherlands
+31 (0)10 4634593
j.lange@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
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
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
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)
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7176 |
| NTR-old | NTR7367 |
| Ander register | Erasmus MC : mec20181040 |