Periodontitis and Upper gi Post-operative Complications

NCT03144973 | Completed DMC

• 1 other identifier: HUS/269/2017
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

Brief Summary

Periodontitis is a infection of mouth gingival mucosa and connecting tissue. It has been shown in previous studies to have a effect on the risk of heart diseases getting worse and elevate risk in heart surgery. The investigators are studying periodontitis and how it affects upper gastrointestinal tract patients complication rates and the quality of complications.

Conditions

Periodontitis; Surgery--Complications

Outcome Measures

Primary Outcomes (1)

• meaning of periodontitis in post operative complications

  Periodontitis is being tested by Periosafe (c) quick-test. Participants with positive results on the test have periodontitis. Participants patient data is being analyzed after surgery and is compared to periodontitis results. The correlation between periodontitis and surgical complications is subject to analysis.

  1 month after surgery

Interventions

periosafe DIAGNOSTIC_TEST

mouth rinsing quick-test

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Need for a upper gi surgery

Sponsors & Collaborators

• Helsinki University Central Hospital: lead

Study Sites (1)

Helsinki university hospital

Helsinki, Finland

Location

MeSH Terms

Conditions

Periodontitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Hanna Seppänen, Phd, Dos

  Helsinki University Central Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: operating surgeons or surgeons in the surgical ward do not get to know the test result so it won't affect in patient care
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PHD student, Junior surgeon

Model Details: All the patients that have upper-gi surgery in our time frame are asked to join in the study

Study Record Dates

• First Submitted: May 3, 2017
• First Posted: May 9, 2017
• Study Start: May 2, 2017
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FI (1)