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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04400136
Other study ID # Lasapienza2020
Secondary ID
Status Not yet recruiting
Phase Early Phase 1
First received
Last updated
Start date July 1, 2020
Est. completion date September 1, 2022

Study information

Verified date May 2020
Source University of Roma La Sapienza
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The trial would to try to establish:

- The best post-operative PPI prescription protocol after Sleeve Gastrectomy

- The impact of PPI therapy on postoperative peptic diseases (erosive gastropathies, ulcers, duodenitis, esophagitis and/or Barrett)

- The impact of PPI therapy on post-operative GERD symptoms (assessed with the use of two standard tests: MRGE-HRQL and GERDQ


Description:

45 patients candidate to primary SG and randomized in 3 study groups (15 per group) GROUP A: no treatment (control group)

GROUP B (standard dose-long term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months

GROUP C (standard dose-short term): Lansoprazole buccal tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 45
Est. completion date September 1, 2022
Est. primary completion date July 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria:

- Patients candidates for primary SG

- Patients adhering to the follow-up protocol

- Age between 18 and 65 years

- No BMI limits

Exclusion Criteria:

- Gastric and/or esophageal diseases (routine preoperative endoscopy)

- Patients candidate for revisional bariatric surgery

- Chronic preoperative PPI therapy

- Using of PPI treatment for postoperative complications

- Conversion to open surgery

- Patients allergic to PPI

- Patients undergoing concomitant surgery

- Patients with hiatal hernia undergoing concomitant cruroplasty

Study Design


Intervention

Drug:
Lansoprazole oral tablets 30 mg
Post operative prescription

Locations

Country Name City State
Italy University of Rome "la sapienza" Latina

Sponsors (1)

Lead Sponsor Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of post-operative GERD based on the trial protocol. Clinical evaluation Questionnaire evaluation (GERD-HRQL score from 0 (no symptoms) to 5 (symptoms worsening daily activity) and GERD-Q (score A <8 no GERD, score A >8 and B > 3 GERD worsening normal life) 12 months
Secondary evaluate in each group of the study (arm type) the endoscopic finding of peptic lesions of the esophagus-gastro-duodenal mucosa at 24 months of follow-up Mucosal damage evaluation and stratified accordingly 24 months
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