Status:
UNKNOWN
Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias
Lead Sponsor:
Odessa National Medical University
Conditions:
Hernia, Hiatal
Eligibility:
All Genders
20-80 years
Phase:
PHASE3
Brief Summary
This study is prospective randomized trial enrolling at least 100 participants which compares efficacy and safety of two alternative methods of laparoscopic hiatal repair for large (i.e. with hiatal s...
Detailed Description
Methods of laparoscopic repair of large and giant hiatal hernias are the most challenging questions in gastrointestinal minimally invasive surgery. The literature demonstrates high rates of anatomical...
Eligibility Criteria
Inclusion
- Type I, II and III hiatal hernias, including complicated by GERD
- Able to undergo elective laparoscopic hiatal hernia repair
- Able to 24 months follow-up with office examinations
- Hiatal surface area (HSA) measuring 10 to 20 sq.cm (by granderath et al, 2007) which correspond to the diameter of hernia defect measuring 5 to 8 cm (the distinct size is determined intraoperatively, those with smaller or larger diameter will be excluded from the study)
Exclusion
- Unable to undergo laparoscopic hiatal hernia repair due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.
- Cases of conversion to open surgery
- Age \< 20 years and \> 80 years
- BMI \< 16 and \> 39 kg/m2
- Pregnancy or plans for pregnancy within next 2 years (in females)
- Uncorrectable coagulopathy and immunosuppression
- Oesophageal motility disorders
- Oesophageal peptic strictures
- Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis, connective tissue disorders (e.g. scleroderma)
- Oesophageal shortening (determined intraoperatively as inability to achieve intra-abdominal length of oesophagus at least 3 cm in spite of intramediastinal oesophageal mobilization)
- Barrett's oesophagus
- History of oesophageal/gastric/duodenal surgery including vagotomy
- Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed gastric/duodenal emptying
Key Trial Info
Start Date :
January 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2016
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01408108
Start Date
January 1 2013
End Date
July 1 2016
Last Update
October 14 2015
Active Locations (1)
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1
Department of surgery # 1 of Odessa national medical university, Odessa regional hospital
Odesa, Ukraine, 65025