To define the optimum laparoscopic hiatus hernia repair, ensuring long-term effect with minimal postoperative side effects.
ID
Source
Brief title
Condition
- Abdominal hernias and other abdominal wall conditions
- Gastrointestinal therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Radiologic integrity of the hiatal repair is the main endpoint.
Secondary outcome
Secondary objectives are clinical recurrence of the hernia, development of
post-operative reflux disease, postoperative side effects and 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. Results of the PRIME trial, in which
non-absorbable mesh reinforcement of the posterior cruroplasty was
investigated, showed equal recurrence compared to primary repair after 6
months. It is hypothesized that circular absorbable mesh reinforcement of the
hiatus could reduce recurrence rate.
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 (110 versus 110).
Intervention
Patients will be randomized to undergo a laparoscopic primary crural repair
with sutures alone or suture repair augmented with prosthetic absorbable,
circular mesh at the hiatus.
Study burden and risks
Preoperatively included patients will undergo an endoscopy and CT scan
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 10 years. Patients will undergo similar to standard post-operative follow-up
and including CT-scan at 3 months and 1 and 5 years after surgery.
Dr. van Heesweg 2
ZWOLLE 8025AB
NL
Dr. van Heesweg 2
ZWOLLE 8025AB
NL
Listed location countries
Age
Inclusion criteria
- Age > 18 years
- Hiatus hernia type II-IV
- Laparoscopic surgical repair clinically indicated
- Fit for surgery
- Suitable for both procedures
Exclusion criteria
- Age < 18 years
- Hiatus hernia type I.
- No informed consent
- Previous anti-reflux surgery or repair for hiatus hernia
- Pregnancy
- Achalasia
Design
Recruitment
Medical products/devices used
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 | NL69356.075.19 |