Laparoscopic mesh-augmented hiatoplasty without verus with fundoplication as a method to treat hiatal hernias with paraesophageal involvement

Laparoscopic mesh-augmented hiatoplasty without verus with fundoplication as a method to treat hiatal hernias with paraesophageal involvement - M*A*S*H 2 - study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004492

Enrollment

Registered

2012-11-07

Start date

2007-03-28

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

K44

Interventions

Group 1: LMAH (laparoscopic mesh-augmented hiatoplasty), it is the interventional technique, in which the controll of symptoms only is treated by mesh-augmented rebuilding of the anatomy at the hiatus

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: age over 18 years, symptomatic hiatal hernia with paraesophageal involvement, patient agreement

Exclusion criteria

Exclusion criteria: hiatal hernia type 0-I; surgery in case of recurrence, 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
Recurrence rate of hiatal hernie: gastroscopy before and 12 month after surgery or if the patient has disorders. Recurrence rate of reflux: gastroscopy before and 12 month after surgery and 24-hours-acidimetry before and 3 months after surgery.	—

Secondary

Measure	Time frame
With 2 questionnaires we tried 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. PPI (proton-pump-inhibitor)-Need was asked in GSRS-questionnaire. 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

With 2 questionnaires we tried 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. PPI (proton-pump-inhibitor)-Need was asked in GSRS-questionnaire. 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 Heidelberg

beat.mueller@med.uni-heidelberg.de06221568641

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 18, 2026