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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03035383
Other study ID # DCiptoMGHAKurnia
Secondary ID
Status Completed
Phase N/A
First received January 22, 2017
Last updated January 25, 2017
Start date October 1, 2013
Est. completion date December 31, 2014

Study information

Verified date January 2017
Source Dr Cipto Mangunkusumo General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Thyroidectomy for large thyroid tumor poses a problem of cosmetics, especially in terms of wide post-operative scar and prominent neck wrinkles. In this manuscript, we performed purse-string suture for the first time for the closure of skin defect after thyroidectomy of large thyroid tumors which resulted in better cosmetics as compared to the conventional suturing method.


Description:

Increasing demand for better cosmetics following thyroidectomy for large thyroid tumor of > 6 cm diameter created a necessity to find an alternative to the conventional technique (CT), which could be addressed by purse string technique (PST). A non-randomized controlled trial was conducted to new thyroid tumor patients at Cipto Mangunkusumo Hospital (RSCM) from October 2013 until December 2014. Thirty patients grouped into two intervention arms of thyroidectomy with PST and CT were assessed for post-operative scar outcomes.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date December 31, 2014
Est. primary completion date December 31, 2014
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria:

- New cases of thyroid tumor in Doctor Cipto Mangunkusumo General Hospital

- Tumor diameter > 6 cm

Exclusion Criteria:

- Previous surgery in the anterior neck area

- Local involvement of lymph nodes requiring nodes dissection

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Purse string technique
Thyroidectomy closure is performed using purse string suturing technique.
Conventional technique
Thyroidectomy closure is performed using conventional suturing technique.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Dr Cipto Mangunkusumo General Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Length of scar Length of scar in milimeter 8 to 12 weeks following thyroidectomy
Primary Width of scar Width of scar in milimeter 8 to 12 weeks following thyroidectomy
Primary Wrinkle Presence of wrinkle 8 to 12 weeks following thyroidectomy
Primary Patient's satisfaction Patient's satisfaction assessed using Likert scale of 1 to 10 8 to 12 weeks following thyroidectomy
Secondary Duration of surgery Duration of surgery in minutes During surgery
Secondary Bleeding Volume of bleeding during surgery in cc During surgery
Secondary Post operative hospital stay Post operative hospital stay 1 week following thyroidectomy
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