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Purse String Suture for the Closure of Large Thyroidectomy Resulted in Better Cosmetics

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ClinicalTrials.gov Identifier: NCT03035383
Recruitment Status : Completed
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmad Kurnia, Dr Cipto Mangunkusumo General Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Thyroidectomy Procedure: Purse string technique Procedure: Conventional technique Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Non-randomized controlled study
Masking: None (Open Label)
Masking Description: No masking
Primary Purpose: Treatment
Official Title: Purse String Suture for the Closure of Large Thyroidectomy Resulted in Better Cosmetics
Actual Study Start Date : October 1, 2013
Actual Primary Completion Date : December 31, 2014
Actual Study Completion Date : December 31, 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cosmetics

Arm Intervention/treatment
Experimental: Purse String Technique
Thyroidectomy closure is performed using purse string technique.
Procedure: Purse string technique
Thyroidectomy closure is performed using purse string suturing technique.
Other Name: PST

Active Comparator: Conventional technique
Thyroidectomy closure is performed using conventional technique.
Procedure: Conventional technique
Thyroidectomy closure is performed using conventional suturing technique.
Other Name: CT




Primary Outcome Measures :
  1. Length of scar [ Time Frame: 8 to 12 weeks following thyroidectomy ]
    Length of scar in milimeter

  2. Width of scar [ Time Frame: 8 to 12 weeks following thyroidectomy ]
    Width of scar in milimeter

  3. Wrinkle [ Time Frame: 8 to 12 weeks following thyroidectomy ]
    Presence of wrinkle

  4. Patient's satisfaction [ Time Frame: 8 to 12 weeks following thyroidectomy ]
    Patient's satisfaction assessed using Likert scale of 1 to 10


Secondary Outcome Measures :
  1. Duration of surgery [ Time Frame: During surgery ]
    Duration of surgery in minutes

  2. Bleeding [ Time Frame: During surgery ]
    Volume of bleeding during surgery in cc

  3. Post operative hospital stay [ Time Frame: 1 week following thyroidectomy ]
    Post operative hospital stay



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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Responsible Party: Ahmad Kurnia, Head of Surgical Oncology, Dr Cipto Mangunkusumo General Hospital
ClinicalTrials.gov Identifier: NCT03035383     History of Changes
Other Study ID Numbers: DCiptoMGHAKurnia
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: No plan to share IPD.

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

Keywords provided by Ahmad Kurnia, Dr Cipto Mangunkusumo General Hospital:
Large thyroid
purse string suture
thyroidectomy