Hiatoplasty with ligamentum teres augmentation vs dorsal hiatoplasty alone for the surgical treatment of postbariatric, symptomatic hiatal hernias

Not Applicable

• Conditions: K44; E66; Diaphragmatic hernia; Obesity

• Registration Number: DRKS00026203
• Lead Sponsor: niversitätsklinikum Freiburg, Departemnt Chirurgie, Klinik für Allgemein- und Viszeralchirurgie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-26
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Patients after Roux- en – Y gastric bypass for obesity
AND
At least 3 symptoms of the symptomatic pbHH cluster: bloating (nausea/vomiting or fullness), abdominal pain, regurgitation, food intolerance or dysphagia
AND
Hiatal hernia > 2cm in gastrografin swallow
AND
Indication and consent to revisional surgery
AND
Signed informed consent to study participation

Exclusion Criteria

Exclusion criteria
• < 18 years of age and > 65 years of age
• Pregnancy
• Lack of the ligamentum teres due to previous upper GI surgery (eg. laparotomy, liver resection, open cholecystectomy)

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptomatic control using GERD HRQL and QOLRAD RI score at 12 months postoperative

Secondary Outcome Measures

Name	Time	Method
Recurrence rates (Gastrografin X ray, Endoscopy)<br>Refluxesophagitis (Endoscopy)<br>Lower esophageal sphincter pressure (manometry)