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

Organizational Data

DRKS-ID:
DRKS00026203
Recruitment Status:
Recruiting planned
Date of registration in DRKS:
2022-01-26
Last update in DRKS:
2022-01-26
Registration type:
Prospective

Acronym/abbreviation of the study

HP alone vs HP+LTA for pbHH

URL of the study

No Entry

Brief summary in lay language

This pilot study investigates whether adding a ligamentum teres augmentation to a dorsal hiatoplasty improves symptomatic control and recurrence rates for patients with a hiatal hernia after gastric bypass surgery, compared to a hiatoplasty alone.

Brief summary in scientific language

This mono-centre randomized, single blinded, controlled pilot study investigates the effect of adding a ligamentum teres augmentation to dorsal hiatoplasty vs hiatoplasty alone on symptomatic control and hernia recurrence in patients with post-bariatric hiatal hernias. The aim of this study is to assess feasibility and enable sample size and power calculation for a planned multi-centre trial.

Health condition or problem studied

ICD10:
K44 - Diaphragmatic hernia
ICD10:
E66 - Obesity
Healthy volunteers:
No Entry

Interventions, Observational Groups

Arm 1:
Dorsal stand-alone hiatoplasty
Arm 2:
Dorsal hiatoplasty with additional ligamentum teres augmentation

Endpoints

Primary outcome:
Symptomatic control using GERD HRQL and QOLRAD RI score at 12 months postoperative
Secondary outcome:
Recurrence rates (Gastrografin X ray, Endoscopy) Refluxesophagitis (Endoscopy) Lower esophageal sphincter pressure (manometry)

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
Yes
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
  • Patient/subject

Recruitment

Recruitment Status:
Recruiting planned
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
Number of study centers:
Monocenter study
Recruitment location(s):
  • University medical center University of Freiburg Freiburg im Breisgau

Recruitment period and number of participants

Planned study start date:
2022-02-14
Actual study start date:
No Entry
Planned study completion date:
No Entry
Actual Study Completion Date:
No Entry
Target Sample Size:
30
Final Sample Size:
No Entry

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
65 Years
Additional Inclusion Criteria:
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)

Addresses

Primary Sponsor

Universitätsklinikum Freiburg, Departemnt Chirurgie, Klinik für Allgemein- und Viszeralchirurgie
Hugstetterstrase 55
79106 Freiburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

Klinik für Allgemein und Viszeralchirurgie, Universitätsklinikum Freiburg
Dr. Mira Runkel
Hugstetterstrasse 55
79106 Freiburg
Germany
Telephone:
076127024010
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

Klinik für Allgemein und Viszeralchirurgie, Universitätsklinikum Freiburg
Dr. Mira Runkel
Hugstetterstrasse 55
79106 Freiburg
Germany
Telephone:
076127024010
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Principal Investigator

Klinik für Allgemein und Viszeralchirurgie, Universitätsklinikum Freiburg
Dr. Mira Runkel
Hugstetterstrasse 55
79106 Freiburg
Germany
Telephone:
076127024010
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Institutional budget, no external funding (budget of sponsor/PI)

Universitätsklinikum Freiburg
Hugstetter Strasse 49
79095 Freiburg
Germany
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
http://www.uniklinik-freiburg.de

Ethics Committee

Address Ethics Committee

Ethik-Kommission der Albert-Ludwigs-Universität Freiburg
Engelberger Str. 21
79106 Freiburg
Germany
Telephone:
+49-761-27072600
Fax:
+49-761-27072630
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2021-10-06
Ethics committee number:
21-1599
Vote of the Ethics Committee:
Approved
Date of the vote:
2022-01-04

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
No Entry
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
No Entry
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry