Digital Mucous CystNCT03199248
A New Surgical Treatment Technique "Aspiration and Percutaneous Capsulotomy" for Digital Mucous Cyst
An observational study of Digital Mucous Cyst, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
Trial summary
Digital mucous cysts (DMCs) are a benign rubbery cystic lesion which usually involve the dorsal or lateral side of DIP joint (digital interphalangeal joint) or proximal nail fold. The most successful treatment way is surgical management. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Digital Mucous Cyst
- What is being tested?
- Aspiration with percutaneous capsulotomy For digital mucous cysts
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 2 Jun 2017to 1 May 2018
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: According to the clinical assessment at OPD(out patient department), DMC was diagnosed. Serial related serial clinical features of DMCs were investigated including pateint's age, location, size of cysts, symptoms, duration, nail bed condition, underlying disease(ex. rheumatoid disease, Diabetes) and previous treatment
Who may be able to join
- According to the clinical assessment at OPD(out patient department), DMC was diagnosed. Serial related serial clinical features of DMCs were investigated including pateint's age, location, size of cysts, symptoms, duration, nail bed condition, underlying disease(ex. rheumatoid disease, Diabetes) and previous treatment
Who cannot join
- autoimmune disease related diffused arthritis, age younger than 20 year-old, severe painful deformity of the involved joint.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taipei veteran general hospital
Taipei
Jung-Pan Wang, PhD, 8862-28757557, jpwang801@gmail.com
About this study
Digital mucous cysts (DMCs) are a benign rubbery cystic lesion which usually involve the dorsal or lateral side of DIP joint (digital interphalangeal joint) or proximal nail fold. The most successful treatment way is surgical management. However, which may cost time, require expertise, may cause infection, prolong wound healing and sometimes may lead to the joint movement limitation. The investigator bring this new technique: percutaneous capsulotomy for digital mucous cysts, which is easy and quick, last but not least, low recurrence rate.
Read the detailed description
Participant
Between 2016 and 2017, 50 participants with DMCs in Taipei veteran general hospital were included in this study. According to the clinical assessment at OPD(out participants department), DMC was diagnosed. Serial related serial clinical features of DMCs were investigated including participant's age, location, size of cysts, symptoms, duration, nail bed condition, underlying disease(ex. rheumatoid disease, Diabetes) and previous treatment. After explaining to participants about the treatment choice (surgical excision, aspiration of cystic contents, and our needle assisted percutaneous capsulotomy for mucous cyst) and participants agreed with accepting needle assisted percutaneous capsulotomy, they were selected for accepting our needle assisted percutaneous capsulotomy for mucous cyst.
Surgical capsulotomy procedure.
The surgical procedure for DMCs was using a 18G needle performing aspiration first and then cutting the stalk tract by the needle tip for capsulotomy. All procedure were done with local anesthesia. After operation, the investigator asking participants using dressing to pressure the wound about 10 minutes to stop bleeding. Later on, the wound was covering with antimicrobial ointment (neomycin) and simple dressing. Educating participants from water for 24 hrs.
Clinical assessments
The investigator evaluating participant's prognosis by VAS, the improvement of fingernail deformity, the participants' subjective satisfaction and the recurrences was evaluating during follow-ups. This clinical study's approval was obtained from Association of IRB, Taipei veteran general hospital.
- Conditions
- Digital Mucous Cyst
- Being tested
- Aspiration with percutaneous capsulotomy For digital mucous cysts
- Keywords
- Digital Mucous Cyst, capsulotomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aspiration with percutaneous capsulotomy For digital mucous cystsProcedure or surgery
Also called Aspiration without percutaneous capsulotomy For digital mucous cysts
The surgical procedure for DMCs was using a 18G needle performing aspiration first and then cutting the stalk tract by the needle tip for capsulotomy. All procedure were done with anesthesia. After operation, we asking patient using dressing to pressure the wound about 10 mins to stop bleeding. Later on, the wound was covering with antimicrobial oint(Neomycin) and simple dressing. Educating patient from water for 24 hr.
| Study group | Role | What they receive |
|---|---|---|
| the participant accepted needle assisted capsulotomy for DMC | Not described Receives: Procedure: Aspiration with percutaneous capsulotomy For digital mucous cysts | |
| the participant accepted aspiration for DMC only | Not described Receives: Procedure: Aspiration with percutaneous capsulotomy For digital mucous cysts |
What is being measured
The primary outcome is the main question the study is designed to answer.
the lesion recurrent or not
6 months later, DMCs recurrence or not.
Measured: 6 months(first evaluation)
Secondary outcomes (2)
Questionnaire
The questionnaire including: satisfaction, joint stiffness, nail deformity, pain score(VAS), pigmentation of the lesion site.
Measured: 3 month after treatment(first evaluation)
Questionnaire
The questionnaire including: satisfaction, joint stiffness, nail deformity, pain score(VAS), pigmentation of the lesion site.
Measured: 6 month after treatment(second evaluation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2017
- Study start2 Jun 2017
- Primary completion1 May 2018 (estimated)
- Study completion1 May 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digital Mucous CystStudies of the same condition, open and under way.
- More trials run by Taipei Veterans General Hospital, TaiwanThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Veterans General Hospital, Taiwan
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03199248
- Sponsor's protocol ID
- 2017-05-012AC
- Status last verified
- Jun 2017
- First submitted
- 30 May 2017
- Last updated
- 14 Jul 2017
- 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 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A New Surgical Treatment Technique "Aspiration and Percutaneous Capsulotomy" for Digital Mucous Cyst
- ClinicalTrials.gov ID
- NCT03199248
- Acronym / sponsor ID
- 2017-05-012AC
- Conditions
- Digital Mucous Cyst
- Keywords
- Digital Mucous Cyst, capsulotomy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taipei Veterans General Hospital, TaiwanOther government
- Study start
- 2 Jun 2017 (actual)
- Primary completion
- 1 May 2018 (estimated)
- Study completion
- 1 May 2018 (estimated)
- First posted
- 26 Jun 2017 (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.
Digital mucous cysts (DMCs) are a benign rubbery cystic lesion which usually involve the dorsal or lateral side of DIP joint (digital interphalangeal joint) or proximal nail fold. The most successful treatment way is surgical management. However, which may cost time, require expertise, may cause infection, prolong wound healing and sometimes may lead to the joint movement limitation. The investigator bring this new technique: percutaneous capsulotomy for digital mucous cysts, which is easy and quick, last but not least, low recurrence rate.
Detailed description
Participant
Between 2016 and 2017, 50 participants with DMCs in Taipei veteran general hospital were included in this study. According to the clinical assessment at OPD(out participants department), DMC was diagnosed. Serial related serial clinical features of DMCs were investigated including participant's age, location, size of cysts, symptoms, duration, nail bed condition, underlying disease(ex. rheumatoid disease, Diabetes) and previous treatment. After explaining to participants about the treatment choice (surgical excision, aspiration of cystic contents, and our needle assisted percutaneous capsulotomy for mucous cyst) and participants agreed with accepting needle assisted percutaneous capsulotomy, they were selected for accepting our needle assisted percutaneous capsulotomy for mucous cyst.
Surgical capsulotomy procedure.
The surgical procedure for DMCs was using a 18G needle performing aspiration first and then cutting the stalk tract by the needle tip for capsulotomy. All procedure were done with local anesthesia. After operation, the investigator asking participants using dressing to pressure the wound about 10 minutes to stop bleeding. Later on, the wound was covering with antimicrobial ointment (neomycin) and simple dressing. Educating participants from water for 24 hrs.
Clinical assessments
The investigator evaluating participant's prognosis by VAS, the improvement of fingernail deformity, the participants' subjective satisfaction and the recurrences was evaluating during follow-ups. This clinical study's approval was obtained from Association of IRB, Taipei veteran general hospital.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the participant accepted needle assisted capsulotomy for DMC | – | Procedure: Aspiration with percutaneous capsulotomy For digital mucous cysts |
| the participant accepted aspiration for DMC only | – | Procedure: Aspiration with percutaneous capsulotomy For digital mucous cysts |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- According to the clinical assessment at OPD(out patient department), DMC was diagnosed. Serial related serial clinical features of DMCs were investigated including pateint's age, location, size of cysts, symptoms, duration, nail bed condition, underlying disease(ex. rheumatoid disease, Diabetes) and previous treatment
Key inclusion criteria (1 listed)
- According to the clinical assessment at OPD(out patient department), DMC was diagnosed. Serial related serial clinical features of DMCs were investigated including pateint's age, location, size of cysts, symptoms, duration, nail bed condition, underlying disease(ex. rheumatoid disease, Diabetes) and previous treatment
Key exclusion criteria (1 listed)
- autoimmune disease related diffused arthritis, age younger than 20 year-old, severe painful deformity of the involved joint.
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 |
|---|---|---|
| Aspiration with percutaneous capsulotomy For digital mucous cystsAlso: Aspiration without percutaneous capsulotomy For digital mucous cystsThe surgical procedure for DMCs was using a 18G needle performing aspiration first and then cutting the stalk tract by the needle tip for capsulotomy. All procedure were done with anesthesia. After operation, we asking patient using dressing to pressure the wound about 10 mins to stop bleeding. Later on, the wound was covering with antimicrobial oint(Neomycin) and simple dressing. Educating patient from water for 24 hr. | Procedure or surgery | the participant accepted aspiration for DMC only, the participant accepted needle assisted capsulotomy for DMC |
Primary outcome
the lesion recurrent or not
Time frame: 6 months(first evaluation)
6 months later, DMCs recurrence or not.
2 secondary outcomes
Questionnaire
Time frame: 3 month after treatment(first evaluation)
Questionnaire
Time frame: 6 month after treatment(second evaluation)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2017.
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.
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 Digital Mucous Cyst, run by Taipei Veterans General Hospital, Taiwan at 1 site in Taiwan.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Jul 2017. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jung-Pan Wang, PhD (8862-28757557, jpwang801@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the lesion recurrent or not (time frame: 6 months(first evaluation)). 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 Jul 2017.