Laparoscopic Repair of Giant Hiatal Hernias With Nitinol-framed Lightweight Polytetrafluoroethylene Mesh (GIANT)
|Hernia, Hiatal||Device: Nitinol-framed lightweight PTFE mesh for hiatal repair Device: Partially absorbable lightweight mesh for hiatal repair||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Prospective Randomized Phase III Study of Laparoscopic Repair of Giant Hiatal Hernias With Nitinol-framed Lightweight Polytetrafluoroethylene Mesh|
- 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 ]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
- Morbidity [ Time Frame: 1 month ]
- Time to discharge [ Time Frame: 1 month ]Time to discharge will be measured in days, from the day of primary surgical procedure, i.e. laparoscopic hiatal hernia repair, to the day of discharge from the hospital
- Number of participants completely recovered from extra-oesophageal complications of hiatal hernia following surgical procedure [ Time Frame: 24 months ]Extra-oesophageal complications of hiatal hernia to be assessed are: asthma, chronic obstructive pulmonary disease, laryngitis, angina, and arrhythmias
|Study Start Date:||June 2013|
|Estimated Study Completion Date:||February 2017|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Nitinol-framed PTFE mesh hiatal repair
Nitinol-framed lightweight PTFE mesh for hiatal repair
Device: Nitinol-framed lightweight PTFE mesh for hiatal repair
The heart-shaped nitinol-framed lightweight PTFE prosthesis "Rebound HRD-Hiatus hernia" (Minnesota Medical Development, Inc.) of small (4,0 x 4,5 cm) to large size (5,5 х 6,0 cm) is sutured to the crura posteriorly to oesophagus with 3 or 5 interrupted non-absorbable (Ethibond 3-0 by Ethicon, Inc.) sutures, thus performing complete tension-free hiatal repair.
Other Name: Rebound HRD-Hiatus hernia
Active Comparator: Lightweight mesh hiatal repair
Partially absorbable lightweight mesh for hiatal repair
Device: Partially absorbable lightweight mesh for hiatal repair
A fashioned according to the dimensions of hernia defect partially absorbable lightweight mesh Ultrapro (Ethicon, Inc.) will be sutured to both crura posteriorly to oesophagus 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).
In both arms procedure will be done in a standard fashion: placement of 30 Fr esophageal bougie, reduction of hernia with excision of hernia sac and mobilization of distal esophagus, exposure of borders of hiatal opening, repair of hiatal hernia defect, a short (2,5 - 3,5 cm) 360° fundoplication wrap (floppy-Nissen procedure).
Other Name: Ultrapro
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01780285
|Department of surgery No. 1 of Odessa national medical university, Odessa regional hospital|
|Odessa, Ukaraine, Ukraine, 65025|
|Principal Investigator:||Volodymyr V. Grubnik, Prof., MD||Department of surgery No. 1 of Odessa national medical university|