Clinical trial NCT03730233: Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing
Official title: Hiatal Hernia Repair by Tension-free Mesh Closure or Simple Suturing of the Diaphragmatic Hiatus. A Randomized, Double Blind Study With a 3-year Follow up.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hiatal Hernia
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2018-11-05
Enrollment: 156
Sex: ALL
Minimum age (years): 20
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: repair by tension-free mesh closure or simple suturing of the diaphragmatic
Primary purpose: TREATMENT

Brief summary: One-hundred and fifty-nine patients undergoing Nissen fundoplication for symptomatic gastro-oesophageal reflux disease (GORD), who had a concomitant hiatal hernia of \> 2 cm axial length, were randomized to closure of the diaphragmatic hiatus with either crural sutures alone or tension-free closure with a non-absorbable mesh. Primary outcome variable was the incidence of radiologically verified recurrent hiatal hernia. Secondary outcomes were per-and postoperative complications and courses, symptomatic recurrence rate, use of PPI, postoperative oesophageal acid exposure and Quality of Life.

Detailed description: The basic principles behind successful surgical repair of the anatomy and function of the gastro-oesophageal junction (GOJ) in gastro-oesophageal reflux disease (GORD) is not only to encircle the distal oesophagus and GOJ by the fundic wrap but also to complete a transhiatal reduction of a concomitant hiatal hernia (type I, HH), aiming for a 2 - 3 cm intra-abdominal length of the of oesophagus and to transact a tension-free hiatal closure. The physiological and morphological characteristics of the diaphragmatic hiatus, however, carry a challenge for the selection of the ideal technique for surgical repair. The diaphragmatic hiatus consists of a three-dimensional structure in constant motion, which creates a border between the counteracting pressures prevailing in the abdominal and chest cavities, respectively. Following hernia reduction, the structural quality of the diaphragmatic pillars is usually weak, offering poor support for the subsequent closure with risk for high recurrence rates. These and other considerations have encouraged the exploration of mesh reinforcement to enhance the durability of the hiatal closure.

Eligibility criteria: Inclusion Criteria:

* patients scheduled for elective laparoscopic total fundoplication
* symptomatic gastro oesophageal reflux disease (GORD) and HH of \> 2 cm in axial length
* total esophageal acid exposure for more than 4 % of monitored time

Exclusion Criteria:

* if insufficient capacity prevailed to understand the study protocol,
* if the patient had undergone previous major upper gastrointestinal surgery (except for GORD or HH)
* ASA classification of \>2 .

Primary outcomes:
measure: Recurrent hiatal hernia
timeFrame: 12 month
Secondary outcomes:
measure: Complications
timeFrame: from operation day up to 12 month
measure: Proton pump inhibitor (PPI)
timeFrame: 12 month
measure: Quality of Life, physical and mental score: SF-36
timeFrame: 12 month
measure: Postoperative oesophageal acid exposure
timeFrame: 12 month
measure: Gastrointestinal symptom rating scale (GSRS)
timeFrame: 12 month
measure: Dysphagia
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Karolinska Institutet
name: Anders Thorell, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Analatos A, Hakanson BS, Lundell L, Lindblad M, Thorell A. Tension-free mesh versus suture-alone cruroplasty in antireflux surgery: a randomized, double-blind clinical trial. Br J Surg. 2020 Dec;107(13):1731-1740. doi: 10.1002/bjs.11917. Epub 2020 Sep 16.