Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias (NCT01408108) | Clinical Trial Compass
UnknownPhase 3
Laparoscopic Lightweight Mesh Repair of Large Hiatal Hernias
Ukraine100 participantsStarted 2013-01
Plain-language 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 surface area (HSA) ranging from 10 to 20 sq.cm, which corresponds to diameter of defect from 5 to 8 cm) types I, II, and III hiatal hernias: primary crural repair and repair with partially absorbable lightweight mesh. According to the literature, rates of anatomical failure and recurrence of GERD after primary repair of large hiatal hernias reach 42 %. Mesh repair decreases rates of failures, however, polypropylene and composite PTFE meshes used most widely, result in unacceptable rates of long-term dysphagia and oesophageal strictures. Our own experience of more than 400 repairs using partially absorbable lightweight mesh Ultrapro (Ethicon) and original sub-lay technique of its fixation precluding contact of the mesh with the oesophagus, showed low recurrence rate and a few cases of long-term dysphagia. Thus, final conclusions could be established by prospective randomized study. Our hypothesis is: original technique of lightweight mesh repair is highly effective for prevention of recurrences compared to primary repair and safe in terms of mesh-related dysphagia and oesophageal strictures. The long-term results (24 months post surgery for every patient) will be studied using symptom questionnaires, quality of life and satisfaction questionnaires, barium studies, endoscopic examinations, 24-hour pH testing, and analysis of possible reoperations.
Who can participate
Age range
20 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Anatomical and functional recurrence of hiatal hernia and GERD