No registrations found.
ID
Source
Brief title
Health condition
Adults with giant hiatal hernia`s.
Sponsors and support
Intervention
Outcome measures
Primary outcome
Radiologic recurrence rate (CT-scan) of hiatal hernia.
Secondary outcome
- Development of post-operative dysphagia.
- Overall satisfaction with surgical outcome.
- Major complications
„X Postoperative hemorrhage with necessity for reoperation
„X Organ perforation (stomach, esophagus, small intestine, colon)
„X Major hemorrhage (>500cc) during operation
„X Lung or cardiac injury during operation
- Minor complications
„X Surgical site infection
„X Minor bleeding (<500cc) during operation
„X Postoperative pneumonia
„X Postoperative urinary tract infection
„X Postoperative deep venous thrombosis
Background summary
Rationale: 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.
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).
Study population: Adult patients with proven hiatus hernia type II-IV (defined by preoperative CT-scan).
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.
Main study parameters/endpoints: Radiologic integrity of the hiatal repair is the main endpoint. Secondary objectives are clinical recurrence of the hernia, development of post-operative reflux disease, postoperative side effects and satisfaction with surgical outcome.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: 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.
Study objective
Bio-aborbable circular mesh reinforcement of the hiatus reduces recurrence rate after hiatal hernia repair.
Study design
3 months postoperatively
3 years postoperatively
Intervention
1. Laparoscopic primary hiatal hernia repair and 180 degrees fundoplication.
2. Laparoscopic primary hiatal repair with circular bio-absorbable mesh reinforcement and 180 degrees fundoplication.
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
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL6331 |
| NTR-old | NTR6523 |
| CCMO | NL69356.075.19 |
| OMON | NL-OMON48062 |