Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias (LARGE)
|Hernia, Hiatal||Procedure: Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh Procedure: Laparoscopic primary posterior crural repair||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Phase III Study of Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias|
- Anatomical and functional recurrence of hiatal hernia and GERD [ Time Frame: 24 months ]Recurrence of hiatal hernia, i.e. anatomical recurrence, will be assessed by symptom questionnaire with visual analogue scales, MAINLY by barium study, and data from possible redo procedures. Recurrence of GERD, i.e. functional recurrence, will be evaluated by symptom questionnaire with visual analogue scales, endoscopic examination with assessment of degree of reflux-oesophagitis according to Los-Angeles classification, and 24 hour pH-testing with calculation of DeMeester score.
- Repair-related dysphagia/oesophageal stricture/prosthetic erosion [ Time Frame: 24 months ]Short- and long-term dysphagia, including due to repair-related oesophageal stricture, will be assessed by symptom questionnaire with visual analogue scales, barium study, endoscopic examination, and data from possible redo procedures. Patients also will be endoscopically assessed for such rare complication as prosthetic erosion of oesophagus.
- Quality of life and satisfaction [ Time Frame: 24 months ]Quality of life and satisfaction will be assessed by GERD-HRQL score
- Operative time [ Time Frame: 1 day ]
- Morbidity [ Time Frame: 1 month ]
- Postoperative hospital stay [ Time Frame: 1 month ]
- Influence on extra-oesophageal complications [ Time Frame: 24 months ]Extra-oesophageal complications to be assessed are: asthma, COPD, laryngitis, angina, and arrhythmias
|Study Start Date:||January 2013|
|Estimated Study Completion Date:||July 2016|
|Primary Completion Date:||July 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Lightweight mesh repair
Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh
Procedure: Laparoscopic hiatal repair with sub-lay partially absorbable lightweight mesh
A fashioned according to the dimensions of hernia defect partially absorbable lightweight mesh Ultrapro™ (Ethicon, Inc.) will be sutured to both crura with 3 to 5 interrupted non-absorbable (Ethibond™ 3-0 by Ethicon, Inc.) sutures (as tension-free repair). Subsequent 2 to 3 interrupted non-absorbable sutures will approximate crura to completely cover a mesh to preclude its contact with the esophagus (original "sandwich" sub-lay technique).
Active Comparator: Primary crural repair
Laparoscopic primary posterior crural repair
Procedure: Laparoscopic primary posterior crural repair
Posterior cruroraphy will be performed with 3 to 4 interrupted non-absorbable (Ethibond™ 3-0 by Ethicon, Inc.) sutures.
In the both arms laparoscopic procedure will be done in a standard fashion: reduction of hernia with excision of hernia sac and mobilization of distal esophagus, exposure of borders of hiatal opening including crura posteriorly to esophagus, repair if hiatal hernia defect (30 Fr esophageal bougie is used), a short (2,5 - 3,5 cm) 360° fundoplication wrap (floppy-Nissen procedure) (30 Fr esophageal bougie is used).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01408108
|Department of surgery # 1 of Odessa national medical university, Odessa regional hospital|
|Odessa, Ukraine, 65025|
|Principal Investigator:||Volodymyr V. Grubnik, Prof., MD||Department of surgery # 1 of Odessa national medical university|