NCT01810081

Brief Summary

In this study, the presence of H.Pylori in the gallbladder mucosa of patients with symptomatic gallstones undergoing cholecystectomy was investigated. Concomitant H.Pylori infection of the gastric mucosa was also investigated to study the relationship of gastric H.Pylori infection to gallstones. It was hypothesized that H.Pylori infection of the gastric mucosa may have a role in the formation of gallstones.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

March 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 6, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 13, 2013

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

March 13, 2013

Status Verified

March 1, 2013

Enrollment Period

2 months

First QC Date

March 6, 2013

Last Update Submit

March 11, 2013

Conditions

Cholelithiasis

Keywords

CholelithiasisGastric H.Pylori infectionH.Pylori infectionGastric mucosa

Outcome Measures

Primary Outcomes (1)

  • Gallstones and concomitant H.Pylori infection of the gastric mucosa

    The relationship between gastric H.Pylori infection and comcomitant gallstones will be evaluated

    3 months

Study Arms (1)

cholecystectomy

cholecystectomy group: H.Pylori infection in gall bladder

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Ninety-four patients with symptomatic gallstones undergoing laparoscopic cholecystectomy were enrolled for the study.

You may qualify if:

  • Patients with acute cholecystitis, cholangitis, biliary and hepatic tumors, Crohn's disease, and previous gastric surgery were not considered suitable for evaluation.

You may not qualify if:

  • Patients undergoing ERCP (endoscopic retrograde cholangio-pancreatography) and patients who have received H.Pylori eradication treatment in the last 6 month were also excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

marmara University School of Medicine

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cholelithiasis

Condition Hierarchy (Ancestors)

Biliary Tract DiseasesDigestive System Diseases

Study Officials

  • A.Ozdemir Aktan, md,PROF

    Marmara University

    STUDY DIRECTOR

Central Study Contacts

M.Umit UGURLU, MD

CONTACT

+905324108010umitugurlu@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist.Prof.

Study Record Dates

First Submitted

March 6, 2013

First Posted

March 13, 2013

Study Start

March 1, 2013

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

March 13, 2013

Record last verified: 2013-03

Locations

TU(1)