PPI Therapy Impact on GERD After Sleeve Gastrectomy

Bariatric Surgery Candidate Clinical Trial

Official title:

Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04400136
• Other study ID #: Lasapienza2020
• Status: Not yet recruiting
• Phase: Early Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Barrett Esophagus
• Esophagitis, Peptic
• Gastro Esophageal Reflux
• Gastroesophageal Reflux

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