Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)
Status
Completed
Conditions
Hernia
Paraesophageal Hernia
Treatments
Device: hernia repair
Details and patient eligibility
About
The purpose of this randomized study is to determine whether a type of mesh derived from a layer of pig small intestine (SIS) is of benefit in treating paraesophageal hernias versus standard surgical suture repair.
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
Inclusion criteria
- Age > 18 years
- Documented symptomatic paraesophageal hernia
- Ability to participate in follow-up evaluation
- Has a telephone
- Free of cognitive or speech impairment
Exclusion criteria
- Patients requiring intra-operative conversion to an open procedure
- Unable to close the crura primarily
- Short esophagus that requires the surgeon to perform a lengthening procedure
- Previous operation of the esphagus or stomach
- Associated gastrointestinal diseases that require extensive medical or surgical intervention that might interfere with quality of like assessment
- Intraoperative full-thickness perforation of the esophagus
- Emergent operation for acute volvulus
- Ineffective peristalsis defined as average amplitude of peristalsis less than 30 mmHg or < 70% propagation of peristaltic waves in the distal esophagus
Trial design
Primary purpose
Treatment
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
None (Open label)
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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