|- candidate number||27301|
|- NTR Number||NTR6523|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||21-mei-2017|
|- Secondary IDs|| |
|- Public Title||Versterking van het middenrif met een kunststof matje bij grote middenrifsbreuken. |
|- Scientific Title||Randomized Controlled Trial of Laparoscopic Primary Crural Repair versus Primary Repair with Anterior Hiatal MESH Reinforcement in Hiatus Hernia|
|- hypothesis||MESH reinforcement of the anterior hiatus reduces recurrence after hiatal hernia repair. |
|- Healt Condition(s) or Problem(s) studied||Hiatal hernia|
|- 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
|- mec approval received||no|
|- multicenter trial||yes|
|- control||Not applicable|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2017|
|- planned closingdate||1-okt-2027|
|- Target number of participants||71|
|- Interventions||1. Laparoscopic primary hiatal hernia repair and 180 degrees fundoplication. |
2. Laparoscopic primary hiatal repair with MESH reinforcement and 180 degrees fundoplication.
|- Primary outcome||Recurrence 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
|- Timepoints||3 months postoperatively|
3 years postoperatively
|- Trial web site||Not applicable. |
|- CONTACT FOR PUBLIC QUERIES|| J.W.A. de Haas|
|- CONTACT for SCIENTIFIC QUERIES|| J.W.A. de Haas|
|- Sponsor/Initiator ||Isala Zwolle|
(Source(s) of Monetary or Material Support)
|Department of Surgery, Isala, Zwolle|
|- Brief 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. Preliminary results of the PRIME trial, in which reinforcement of the posterior hiatus was investigated, showed equal recurrence compared to primary repair. It is hypothesized that MESH reinforcement of the anterior 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 (36 versus 36).
Study population: Adult patients with proven hiatus hernia type II-IV.
Intervention: Patients will be randomized to undergo a laparoscopic primary repair with sutures alone (posterior and anterior) or sutures augmented with prosthetic mesh at the anterior hiatus.
Main study parameters/endpoints: Radiologic integrity of the hiatal repair is the main endpoint. Secondary objectives include clinical recurrence of the hernia, development of post-operative reflux disease, postoperative side effects and overall 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 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.
|- Main changes (audit trail)|
|- RECORD||21-mei-2017 - 14-jul-2017|