Randomized, Prospective Controlled Trial of Paraesophageal Hernia Repair With Small Intestinal Submucosa (SIS)

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00272922

Enrollment

150

Registered

2006-01-09

Start date

2002-07-31

Completion date

2006-07-31

Last updated

2007-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hernia, Paraesophageal Hernia

Keywords

Biomaterials, Paraesophageal Hernia, Laparoscopy

Brief summary

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.

Interventions

DEVICEhernia repair

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026