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

Laparoscopic mesh-augmented hiatoplasty versus fundoplication as a treatment for gastroesophageal reflux disease - M*A*S*H - Studie

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004495

Enrollment

Registered

2012-11-09

Start date

2006-10-04

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K21.9

Interventions

Group 1: LMAH (laparoscopic mesh-augmented hiatoplasty), it is the interventional technique, in which the controll of reflux symptoms only is treated by a lengthening of the esophagus, mesh-augmented

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Secondary

Measure	Time frame
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. Process while surgery and after surgery. Re-hospitalisation, pain, pressur of esophagus, complications while surgery, morbidity, Reintervention. The patients said in the questionnaire how strong they see their pain before operation, 3, 12 and 36 month after operation. The pressure of esophagus was measured by manometry before and 3 months after surgery.	—

Measure

Time frame

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. Process while surgery and after surgery. Re-hospitalisation, pain, pressur of esophagus, complications while surgery, morbidity, Reintervention. The patients said in the questionnaire how strong they see their pain before operation, 3, 12 and 36 month after operation. The pressure of esophagus was measured by manometry before and 3 months after surgery.

—

Countries

Germany, Switzerland

Contacts

Public ContactBeat Müller

Chirurgische Universitätsklinik

beat.mueller@med.uni-heidelberg.de06221568641

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026