Significance of small axial hiatal hernias and moderate forms of esophagitis before and after bariatric surgery: New scoring system to aid decision-making regarding simultaneous hiatal repair during bariatric surgery

Significance of small axial hiatal hernias and moderate forms of esophagitis before and after bariatric surgery: New scoring system to aid decision-making regarding simultaneous hiatal repair during bariatric surgery - HHR1

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00037541

Enrollment

500

Registered

2025-07-31

Start date

2026-07-01

Completion date

Unknown

Last updated

2026-03-02

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

Conditions

E66.0

Interventions

Group 1: In the study, the usual basic bariatric data for all patients is retrospectively recorded in tabular form

specifically, this includes •Age •Gender •Preoperative BMI (for surgical indication) •Primary bariatric procedure (sleeve or MGB) •Months since primary surgery (0 = preoperative) In addition, the foll

max. 45 points

this FB records characteristic symptoms

in addition, always record the pure value 7.Bariatric Quality of Life questionnaire (BQL 40 or higher / 20-39 / 0-19

max. 65 points)

useful, as some patients are satisfied despite corresponding complaints or do not feel a high level of suffering, which is also taken into account in the indications

in addition, the pure value is always recorded, as there is no reliable information on limit values in the literature

other studies have also handled this in the same way 8.Nicotine (no / former / yes), regardless of quantity 9.Alcohol (no / occasionally / regularly), regardless of quantity Either the absolute number

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: •StuDoQ consent (national data registry of the German Society for General and Visceral Surgery, DGAV) for metabolic and bariatric procedures (MBE) •All primary sleeves and MGBs 2020-2022 from WKK Heide, which will amount to approximately 400-500 inclusions •Maximum follow-up period until the end of 2024

Exclusion criteria

Exclusion criteria: •Previous surgery on the stomach/diaphragm •Under 18 and over 70 years of age •Lack of StuDoQ consent

Design outcomes

Primary

Measure	Time frame
•Creation of a structured assessment for indication assistance with regard to a pHHR (scoring system), both with and without consideration of gastroscopy data (as these may be inconsistent in the postoperative course, see above) •Defining a scoring value as an aid for determining the indication for pHHR (value XX, below which no HHR is required vs. value YY, above which HHR should be performed)	—

Measure

Time frame

•Creation of a structured assessment for indication assistance with regard to a pHHR (scoring system), both with and without consideration of gastroscopy data (as these may be inconsistent in the postoperative course, see above) •Defining a scoring value as an aid for determining the indication for pHHR (value XX, below which no HHR is required vs. value YY, above which HHR should be performed)

—

Secondary

Measure	Time frame
•Clinical course (scores, BMI, RSI, PPI, etc.) of all patients without pHHR with preoperative ax HH 1–3 cm vs. no ax HH (relevance of small preoperative HH) •Clinical course (scores, BMI, RSI, PPI, etc.) of all patients without pHHR with preoperative esophagitis LA A/B or SM 0/1 vs. no esophagitis (relevance of mild preoperative esophagitis) •Clinical course (scores, BMI, RSI, PPI, etc.) of all patients without pHHR with preoperative small axial hiatal hernia and esophagitis LA A/B (or SM 0/1) vs. neither (relevance of preoperative combination of small HH and mild esophagitis A) •Clinical course of all patients with pHHR vs. without (scores, BMI, RSI, PPI, etc.) •Detailed analysis (probably too few cases): How many and which patients (progression data as above) with and without pHHR undergo hiatal surgery (sHHR) during the observation period? •Differences in overall course and scores between sleeve and MGB with regard to all of the above secondary objectives (number of cases?) •Record all patients in the observation period without postoperative gastroscopy and arrange for this to be performed in accordance with the current IFSO recommendations.	—

Measure

Time frame

•Clinical course (scores, BMI, RSI, PPI, etc.) of all patients without pHHR with preoperative ax HH 1–3 cm vs. no ax HH (relevance of small preoperative HH) •Clinical course (scores, BMI, RSI, PPI, etc.) of all patients without pHHR with preoperative esophagitis LA A/B or SM 0/1 vs. no esophagitis (relevance of mild preoperative esophagitis) •Clinical course (scores, BMI, RSI, PPI, etc.) of all patients without pHHR with preoperative small axial hiatal hernia and esophagitis LA A/B (or SM 0/1) vs. neither (relevance of preoperative combination of small HH and mild esophagitis A) •Clinical course of all patients with pHHR vs. without (scores, BMI, RSI, PPI, etc.) •Detailed analysis (probably too few cases): How many and which patients (progression data as above) with and without pHHR undergo hiatal surgery (sHHR) during the observation period? •Differences in overall course and scores between sleeve and MGB with regard to all of the above secondary objectives (number of cases?) •Record all patients in the observation period without postoperative gastroscopy and arrange for this to be performed in accordance with the current IFSO recommendations.

—

Countries

Germany

Contacts

Public ContactErik Schlöricke

Westküstenklinikum Heide

erik.schloericke@wkk.sh+49 481 7851301

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 14, 2026