Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
NCT ID:
NCT01408108
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
80 Years
Study:
NCT01408108
Study Brief:
Protocol Section:
NCT01408108