A New Surgical Treatment Technique "Aspiration and Percutaneous Capsulotomy" for Digital Mucous Cyst

July 13, 2017 updated by: Taipei Veterans General Hospital, Taiwan
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Taipei Veteran General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • autoimmune disease related diffused arthritis, age younger than 20 year-old, severe painful deformity of the involved joint.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
the participant accepted needle assisted capsulotomy for DMC
Procedure: Aspiration with 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.
Other Names:
  • Aspiration without percutaneous capsulotomy For digital mucous cysts
the participant accepted aspiration for DMC only
Procedure: Aspiration with 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.
Other Names:
  • Aspiration without percutaneous capsulotomy For digital mucous cysts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the lesion recurrent or not
Time Frame: 6 months(first evaluation)
6 months later, DMCs recurrence or not.
6 months(first evaluation)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Questionnaire
Time Frame: 3 month after treatment(first evaluation)
The questionnaire including: satisfaction, joint stiffness, nail deformity, pain score(VAS), pigmentation of the lesion site.
3 month after treatment(first evaluation)
Questionnaire
Time Frame: 6 month after treatment(second evaluation)
The questionnaire including: satisfaction, joint stiffness, nail deformity, pain score(VAS), pigmentation of the lesion site.
6 month after treatment(second evaluation)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Veterans General Hospital, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 2, 2017

Primary Completion (Anticipated)

May 1, 2018

Study Completion (Anticipated)

May 1, 2018

Study Registration Dates

First Submitted

May 30, 2017

First Submitted That Met QC Criteria

June 23, 2017

First Posted (Actual)

June 26, 2017

Study Record Updates

Last Update Posted (Actual)

July 14, 2017

Last Update Submitted That Met QC Criteria

July 13, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-05-012AC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Digital Mucous Cyst

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovakia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe