Quality of LifeNCT04514263
Oral Biopsies: Evaluation of the Post-surgical Discomfort
An observational study of Quality of Life and Biopsy Wound, run by Catholic University of the Sacred Heart at 1 site in Italy.
Trial summary
Aim of this study is to evaluate the post-operative course in patients undergoing diagnostic or therapeutic oral mucosal biopsies. To evaluate the wound healing, all variables connected with the surgery (including post-operative complications) were recorded. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life, Biopsy Wound, Surgical Wound
- What is being tested?
- OHIP-14 Administration and VNS Administration
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteItaly
- Study dates
- 8 Jan 2018to 8 Dec 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Eighty-four patients were enrolled in this study; four of them were excluded because the clinical records were incomplete. Among the 80 patients left, 30 were males and 50 females, with a mean age of 60.25 years (range 23-88); clinical data about remote pathological history were collected: 31/80 patients did not have any systemic diseases, 22/80 only one disease, 27/80 more than one disease; 36/80 patients did not take any drug, 16/80 only one and 28/80 more than one; 63/80 patients did not smoke, 10/80 were former smokers and 7/80 were smokers.
Who may be able to join
- no systemic or local contraindications for surgical treatment
- need for an oral biopsy (both excisional and incisional).
Who cannot join
- Since no absolute contraindications to oral biopsies are reported, no exclusion criteria were selected for this study, but if any relative contraindication was present (i.e. bleeding disorders) biopsy was performed after the resolution of the problem
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Post-surgical Discomfort in Patients Undergoing Diagnostic Oral Biopsies
Aim of this study is to evaluate the post-operative course in patients undergoing diagnostic or therapeutic oral mucosal biopsies.
To evaluate the wound healing, all variables connected with the surgery (including post-operative complications) were recorded. To evaluate the psychological and behavioral impact of the post-operative discomfort, two survey tools were administered: OHIP-14 and visual number scale of pain (VNS) were administered at 6h, 7 days and 21 days after biopsy.
- Conditions
- Quality of Life, Biopsy Wound, Surgical Wound, Healing Surgical Wounds
- Being tested
- OHIP-14 Administration, VNS Administration
- Medical subject headings
- Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OHIP-14 AdministrationOther
All patients fulfilled the OHIP-14 questionnaire three times: six hours, seven days and twenty-one days after the biopsy
VNS AdministrationOther
All patients fulfilled the VNS scale three times: six hours, seven days and twenty-one days after the biopsy
| Study group | Role | What they receive |
|---|---|---|
| Oral Biopsy | Patients with oral lesions undergoing diagnostic or therapeutic biopsies either for benign lesions or potentially malignant disorders or malignant lesions or salivary glands diseases. Receives: Other: OHIP-14 Administration; Other: VNS Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between the clinical healing and patient perception
To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process.
Measured: Six hours after an oral biopsy
Correlation between the clinical healing and patient perception
To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process.
Measured: One week after an oral biopsy
Correlation between the clinical healing and patient perception
To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process.
Measured: Three weeks after an oral biopsy
Secondary outcomes (6)
Correlation between OHIP-14 and VNS scale
Correlation between two different tools evaluating patient perception
Measured: Six hours after an oral biopsy
Correlation between OHIP-14 and VNS scale
Correlation between two different tools evaluating patient perception
Measured: One week after an oral biopsy
Correlation between OHIP-14 and VNS scale
Correlation between two different tools evaluating patient perception
Measured: Three weeks after an oral biopsy
Clinical variables which influence the healing and patient perception
To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.
Measured: Six hours after an oral biopsy
Clinical variables which influence the healing and patient perception
To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.
Measured: One week after an oral biopsy
Clinical variables which influence the healing and patient perception
To evaluate which clinical variable (systemic or local) can modify the wound healing or the patient perception.
Measured: Three weeks after an oral biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2020
- Study start8 Jan 2018
- Primary completion8 Mar 2019
- Study completion8 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catholic University of the Sacred Heart
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carlo Lajolo, Catholic University of the Sacred Heart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04514263
- Sponsor's protocol ID
- OHIP-OB
- Status last verified
- Aug 2020
- First submitted
- 6 Aug 2020
- Last updated
- 14 Aug 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Post-surgical Discomfort in Patients Undergoing Diagnostic Oral Biopsies
- ClinicalTrials.gov ID
- NCT04514263
- Acronym / sponsor ID
- OHIP-OB
- Conditions
- Quality of Life, Biopsy Wound, Surgical Wound, Healing Surgical Wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Catholic University of the Sacred HeartUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 8 Mar 2019 (actual)
- Study completion
- 8 Dec 2019 (actual)
- First posted
- 14 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Aim of this study is to evaluate the post-operative course in patients undergoing diagnostic or therapeutic oral mucosal biopsies.
To evaluate the wound healing, all variables connected with the surgery (including post-operative complications) were recorded. To evaluate the psychological and behavioral impact of the post-operative discomfort, two survey tools were administered: OHIP-14 and visual number scale of pain (VNS) were administered at 6h, 7 days and 21 days after biopsy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Oral Biopsy | – | Other: OHIP-14 Administration, Other: VNS AdministrationPatients with oral lesions undergoing diagnostic or therapeutic biopsies either for benign lesions or potentially malignant disorders or malignant lesions or salivary glands diseases. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Eighty-four patients were enrolled in this study; four of them were excluded because the clinical records were incomplete. Among the 80 patients left, 30 were males and 50 females, with a mean age of 60.25 years (range 23-88); clinical data about remote pathological history were collected: 31/80 patients did not have any systemic diseases, 22/80 only one disease, 27/80 more than one disease; 36/80 patients did not take any drug, 16/80 only one and 28/80 more than one; 63/80 patients did not smoke, 10/80 were former smokers and 7/80 were smokers.
Key inclusion criteria (2 listed)
- no systemic or local contraindications for surgical treatment
- need for an oral biopsy (both excisional and incisional).
Key exclusion criteria (1 listed)
- Since no absolute contraindications to oral biopsies are reported, no exclusion criteria were selected for this study, but if any relative contraindication was present (i.e. bleeding disorders) biopsy was performed after the resolution of the problem
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OHIP-14 AdministrationAll patients fulfilled the OHIP-14 questionnaire three times: six hours, seven days and twenty-one days after the biopsy | Other | Oral Biopsy |
| VNS AdministrationAll patients fulfilled the VNS scale three times: six hours, seven days and twenty-one days after the biopsy | Other | Oral Biopsy |
Primary outcome
Correlation between the clinical healing and patient perception
Time frame: Six hours after an oral biopsy
To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process.
Correlation between the clinical healing and patient perception
Time frame: One week after an oral biopsy
To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process.
Correlation between the clinical healing and patient perception
Time frame: Three weeks after an oral biopsy
To evaluate whether the clinical evaluation of a wound healing shows a correspondence with the patient perception of the same process.
6 secondary outcomes
Correlation between OHIP-14 and VNS scale
Time frame: Six hours after an oral biopsy
Correlation between OHIP-14 and VNS scale
Time frame: One week after an oral biopsy
Correlation between OHIP-14 and VNS scale
Time frame: Three weeks after an oral biopsy
Clinical variables which influence the healing and patient perception
Time frame: Six hours after an oral biopsy
Clinical variables which influence the healing and patient perception
Time frame: One week after an oral biopsy
Clinical variables which influence the healing and patient perception
Time frame: Three weeks after an oral biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Quality of Life and Biopsy Wound, run by Catholic University of the Sacred Heart at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation between the clinical healing and patient perception (time frame: Six hours after an oral biopsy). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2020.