PPI Therapy Impact on GERD After Sleeve Gastrectomy
Impact of Treatment With Protonic Pump Inhibitors After Laparoscopic Sleeve Gastrectomy on Gastro-esophageal Reflux Disease Symptoms: Pilot Study
1 other identifier
interventional
45
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for early_phase_1
Started Jul 2020
Typical duration for early_phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2020
CompletedFirst Posted
Study publicly available on registry
May 22, 2020
CompletedStudy Start
First participant enrolled
July 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedMay 22, 2020
May 1, 2020
1 year
May 13, 2020
May 20, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
24 months
Study Arms (3)
GROUP A - no PPI
NO INTERVENTIONno PPI treatment (control group)
GROUP B PPI 1/day for 6 months
EXPERIMENTAL(standard dose-long term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 6 months
GROUP C PPI 1/day for 3 months
EXPERIMENTAL(standard dose-short term): Lansoprazole oral tablets 30 mg once daily (before breakfast on an empty stomach) for 3 months
Interventions
Post operative prescription
Eligibility Criteria
You may qualify if:
- Patients candidates for primary SG
- Patients adhering to the follow-up protocol
- Age between 18 and 65 years
- No BMI limits
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Rome "la sapienza"
Latina, 04100, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- early phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- DIAGNOSTIC
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD PhD
Study Record Dates
First Submitted
May 13, 2020
First Posted
May 22, 2020
Study Start
July 1, 2020
Primary Completion
July 1, 2021
Study Completion
September 1, 2022
Last Updated
May 22, 2020
Record last verified: 2020-05