aparoscopic mesh-augmented hiatoplasty versus fundoplication as a treatment for gastroesophageal reflux disease

Not Applicable

• Conditions: K21.9; Gastro-oesophageal reflux disease without oesophagitis

• Registration Number: DRKS00004495
• Lead Sponsor: Chirurgische Universitätsklinik

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-09
• Study Completion: 2019-08-14
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

age over 18 years, endoscopical or acidimetrial proof of gastroesophageal reflux disease, consequent proton-pump-inhibitor therapie for at least 3 months, patient agreement

Exclusion Criteria

hiatal hernia type II-IV; surgery in case of recurrence, secundary gastroesophageale reflux disease, achalasia, Zollinger-Ellison-Syndrome, malignant tumour, ASA IV-V(American Society of Anesthesiologists), incompetence linguistical or mental to answer the questionaire

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In first line (main objecitve) we tried to say, if there are less surgical side-effects after laparoscopic mesh-augmented hiatoplasty in comparison with laparoscopic fundoplication. For this wie used 2 questionnaires to find out about disorders and quality of life. We used for disorders the Gastrointestinal Symptom Rating Scale (GSRS) and for quality of life the Gastrointestinal Quality of Life Index (GIQLI). These two questionnaires were answered before surgery and 3, 12 and 36 month after surgery.

Secondary Outcome Measures

Name	Time	Method
Secondary objective is to say, if the lapaorscopic mesh-augmented hiatoplasty has an equal effect like laparoscopic fundoplication on recurrence rate of reflux: gastroscopy before and 12 month after surgery and 24-hours-acidimetry before and 3month after surgery. PPI (proton-pump-inhibitor)-Need was asked in GSRS-questionnaire before operation, 3, 12 and 36 month after operation. <br>Process while surgery and after surgery. Re-hospitalisation, pain, pressur of esophagus, complications while surgery, morbidity, Reintervention.<br>The patients said in the questionnaire how strong they see their pain before operation, 3, 12 and 36 month after operation.<br>The pressure of esophagus was measured by manometry before and 3 months after surgery.<br>