THE EFFECT OF HELICOBACTER PYLORI ERADICATION THERAPY TO GASTRIC WALL THICKNESS BEFORE THE LAPAROSCOPIC SLEEVE GASTRECTOMY

NCT03757650 | Completed Phase 4 DMC

• 1 other identifier: ANIL ERGIN
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

Laparoscopic sleeve gastrectomy is one of the most popular bariatric surgery in the world. The most important complication about this surgery that the leakage from the stapler line because of the inconvenient stapler choice..The stapler colour has to be chosen to the gastric wall thickness. It is not known well that the effect of Helicobacter pylori to gastric wall thickness Nobody pay any attention about being Helicobacter pylori positive when they are choosing stapler colour during the Laparoscopic sleeve gastrectomy so that everybody use the same type of stapler in Helicobacter pylori positive and negative patients during the Laparoscopic sleeve gastrectomy .Because of this inconvenient staplers use in the Laparoscopic sleeve gastrectomy the risk of leakage would be increase. Purpose of this research is that what is the effect of Helicobacter pylori to the gastric wall thickness and if the patients who will undergo Laparoscopic sleeve gastrectomy take the Helicobacter pylori eradication therapy before the surgery will gastric wall thickness increase or decrease. .

Conditions

Helicobacter Pylori Infection; Obesity, Morbid

Keywords

obesity; laparoscopic sleeve gastrectomy; helicobacter pylori; gastric wall thickness

Outcome Measures

Primary Outcomes (1)

• measurements of gastric wall thickness

  The effect of Helicobacter Pylori eradication therapy to the gastric wall thickness

  one month

Secondary Outcomes (1)

• Choosing the correct stapler colour during Laparoscopic Sleeve Gastrectomy by accounting gastric wall thickness thanks to knowing effect of HP positivity to gastric wall thickness

  one month

Study Arms (3)

HP eradication therapy positive-HP positive

ACTIVE COMPARATOR

who has HP positive endoscopic biopsy will take HP eradication therapy one month before the surgery

Drug: Bismuth Subsalicylate

HP eradication therapy negative-HP positive

ACTIVE COMPARATOR

who has HP positive endoscopic biopsy and will not take any medication about HP

Drug: Bismuth Subsalicylate

HP negative-Control group

NO INTERVENTION

who has HP negative endoscopic biopsy and will not take any medication. (control group)

Interventions

Bismuth Subsalicylate DRUG

omeprazole 2x1) + clarithromycin 2x500 mg + amoxicilline 2x1000 mg + Bismuth Subsalicylate 2x1

Also known as: amoxicillin, clarithromycin, omeprazole

HP eradication therapy negative-HP positive; HP eradication therapy positive-HP positive

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients who will undergo to LSG will have upper gastrointestinal system endoscopy before the surgery and positive HP results.

You may not qualify if:

• Having allergy to the medications which use for the HP eradication therapy
• The patients who is incompatible for the HP eradication therapy
• The patients who decided to undergo to another bariatric surgery peroperatively

Sponsors & Collaborators

• Fatih Sultan Mehmet Training and Research Hospital: lead

Study Sites (1)

Fatih Sultan Mehmet Research and Training Hospital

Istanbul, 34734, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Obesity, Morbid; Obesity

Interventions

bismuth subsalicylate; Amoxicillin; Clarithromycin; Omeprazole

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillin G; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Erythromycin; Macrolides; Polyketides; Lactones; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Pyridines; Heterocyclic Compounds, 1-Ring; Benzimidazoles

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Anil ERGIN , General Surgery , Asistant doctor

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: October 1, 2018
• Primary Completion: November 1, 2020
• Study Completion: February 1, 2021
• Last Updated: March 23, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)