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Trial record 2 of 2 for:    "Mucocele"
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A New Surgical Treatment Technique "Aspiration and Percutaneous Capsulotomy" for Digital Mucous Cyst

This study is currently recruiting participants.
See Contacts and Locations
Verified June 2017 by Taipei Veterans General Hospital, Taiwan
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier:
NCT03199248
First received: May 30, 2017
Last updated: July 13, 2017
Last verified: June 2017
History of Changes
  Purpose
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.

Condition Intervention
Digital Mucous Cyst Procedure: Aspiration with percutaneous capsulotomy For digital mucous cysts

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: A New Surgical Treatment Technique "Aspiration and Percutaneous Capsulotomy" for Digital Mucous Cyst

Further study details as provided by Taipei Veterans General Hospital, Taiwan:

Primary Outcome Measures:
  • the lesion recurrent or not [ Time Frame: 6 months(first evaluation) ]
    6 months later, DMCs recurrence or not.


Secondary Outcome Measures:
  • 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.

  • 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.
Estimated Enrollment: 50
Actual Study Start Date: June 2, 2017
Estimated Study Completion Date: May 1, 2018
Estimated Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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 Name: 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 Name: Aspiration without percutaneous capsulotomy For digital mucous cysts

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.

  Eligibility
Ages Eligible for Study:   20 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03199248

Contacts
Contact: Jung-Pan Wang, PhD 8862-28757557 jpwang801@gmail.com

Locations
Taiwan
Taipei veteran general hospital Recruiting
Taipei, Taiwan
Contact: Jung-Pan Wang, PhD    8862-28757557    jpwang801@gmail.com   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
  More Information

Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03199248     History of Changes
Other Study ID Numbers: 2017-05-012AC
Study First Received: May 30, 2017
Last Updated: July 13, 2017

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Taipei Veterans General Hospital, Taiwan:
Digital Mucous Cyst
capsulotomy

Additional relevant MeSH terms:
Cysts
Mucocele
Synovial Cyst
Neoplasms
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on July 14, 2017