To define the optimum laparoscopic hiatus hernia repair, ensuring long-term effect with minimal postoperative side effects.
ID
Source
Brief title
Condition
- Gastrointestinal conditions NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Integrity of the hiatal repair is the main endpoint.
Secondary outcome
Secondary objectives include clinical recurrence of the hernia, development of
post-operative reflux disease, postoperative side effects, operation time,
hospital admission and overall satisfaction with surgical outcome
Background summary
Laparoscopic hiatus hernia repair is associated with a high recurrence rate.
Repair reinforced with mesh lowers short-term recurrence but can cause
dysphagia and visceral erosion. Previous studies evaluating lightweight
polypropylene mesh (TiMesh) for repair of hiatal hernia demonstrated good
symptomatic and clinical outcome. However, recurrence rates in the long term
are unknown.
Study objective
To define the optimum laparoscopic hiatus hernia repair, ensuring long-term
effect with minimal postoperative side effects.
Study design
Prospective blinded randomized controlled superiority trial comparing two
laparoscopic procedures for hiatus hernia repair (36 versus 36).
Intervention
Patients will be randomized to undergo a laparoscopic primary repair with
sutures alone or sutures augmented with prosthetic mesh.
Study burden and risks
Preoperatively included patients will undergo an endoscopy and barium meal
X-ray according to standard clinical practice. Questionnaires will be filled in
pre-operatively and at 3, 6, 12 months post-operatively and then yearly for up
to 20 years. Patients will undergo similar to standard post-operative
follow-up and including Barium meal X-ray and endoscopy at 3 months and 3
years after surgery.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
- Age >= 18 years
- Hiatus hernia
- Laparoscopic surgical repair clinically indicated
- Fit for surgery
- Suitable for any both procedure
Exclusion criteria
- Age < 18 years
- No informed consent
- Previous anti-reflux surgery or repair for hiatus hernia
- Pregnant
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL42495.100.12 |
| Other | NTR 14169 (voorlopig, is aangevraagd) |
| OMON | NL-OMON23150 |