NCT03035383

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2013

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2014

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

January 22, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 30, 2017

Completed
Last Updated

January 30, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

January 22, 2017

Last Update Submit

January 25, 2017

Conditions

Keywords

Large thyroidpurse string suturethyroidectomy

Outcome Measures

Primary Outcomes (4)

  • Length of scar

    Length of scar in milimeter

    8 to 12 weeks following thyroidectomy

  • Width of scar

    Width of scar in milimeter

    8 to 12 weeks following thyroidectomy

  • Wrinkle

    Presence of wrinkle

    8 to 12 weeks following thyroidectomy

  • Patient's satisfaction

    Patient's satisfaction assessed using Likert scale of 1 to 10

    8 to 12 weeks following thyroidectomy

Secondary Outcomes (3)

  • Duration of surgery

    During surgery

  • Bleeding

    During surgery

  • Post operative hospital stay

    1 week following thyroidectomy

Study Arms (2)

Purse String Technique

EXPERIMENTAL

Thyroidectomy closure is performed using purse string technique.

Procedure: Purse string technique

Conventional technique

ACTIVE COMPARATOR

Thyroidectomy closure is performed using conventional technique.

Procedure: Conventional technique

Interventions

Thyroidectomy closure is performed using purse string suturing technique.

Also known as: PST
Purse String Technique

Thyroidectomy closure is performed using conventional suturing technique.

Also known as: CT
Conventional technique

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • New cases of thyroid tumor in Doctor Cipto Mangunkusumo General Hospital
  • Tumor diameter \> 6 cm

You may not qualify if:

  • Previous surgery in the anterior neck area
  • Local involvement of lymph nodes requiring nodes dissection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Non-randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Surgical Oncology

Study Record Dates

First Submitted

January 22, 2017

First Posted

January 30, 2017

Study Start

October 1, 2013

Primary Completion

December 31, 2014

Study Completion

December 31, 2014

Last Updated

January 30, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

No plan to share IPD.