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

January 25, 2017 updated by: Ahmad Kurnia, Dr Cipto Mangunkusumo General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 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

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • PST
Active Comparator: Conventional technique
Thyroidectomy closure is performed using conventional technique.
Procedure: Conventional technique
Thyroidectomy closure is performed using conventional suturing technique.
Other Names:
  • CT

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Length of scar
Time Frame: 8 to 12 weeks following thyroidectomy
Length of scar in milimeter
8 to 12 weeks following thyroidectomy
Width of scar
Time Frame: 8 to 12 weeks following thyroidectomy
Width of scar in milimeter
8 to 12 weeks following thyroidectomy
Wrinkle
Time Frame: 8 to 12 weeks following thyroidectomy
Presence of wrinkle
8 to 12 weeks following thyroidectomy
Patient's satisfaction
Time Frame: 8 to 12 weeks following thyroidectomy
Patient's satisfaction assessed using Likert scale of 1 to 10
8 to 12 weeks following thyroidectomy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of surgery
Time Frame: During surgery
Duration of surgery in minutes
During surgery
Bleeding
Time Frame: During surgery
Volume of bleeding during surgery in cc
During surgery
Post operative hospital stay
Time Frame: 1 week following thyroidectomy
Post operative hospital stay
1 week following thyroidectomy

Collaborators and Investigators

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

Sponsor

Dr Cipto Mangunkusumo General Hospital

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)

October 1, 2013

Primary Completion (Actual)

December 31, 2014

Study Completion (Actual)

December 31, 2014

Study Registration Dates

First Submitted

January 22, 2017

First Submitted That Met QC Criteria

January 25, 2017

First Posted (Estimate)

January 30, 2017

Study Record Updates

Last Update Posted (Estimate)

January 30, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • DCiptoMGHAKurnia

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share IPD.

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.

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