ThyroidectomyNCT03035383
Purse String Suture for the Closure of Large Thyroidectomy Resulted in Better Cosmetics
A study testing Purse string technique and Conventional technique in people with Thyroidectomy, run by Dr Cipto Mangunkusumo General Hospital.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroidectomy
- What is being tested?
- Purse string technique and Conventional technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2013to 31 Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- New cases of thyroid tumor in Doctor Cipto Mangunkusumo General Hospital
- Tumor diameter > 6 cm
Who cannot join
- Previous surgery in the anterior neck area
- Local involvement of lymph nodes requiring nodes dissection
About this study
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.
Read the 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.
- Conditions
- Thyroidectomy
- Being tested
- Purse string technique, Conventional technique
- Keywords
- Large thyroid, purse string suture, thyroidectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Purse string techniqueProcedure or surgery
Also called PST
Thyroidectomy closure is performed using purse string suturing technique.
Conventional techniqueProcedure or surgery
Also called CT
Thyroidectomy closure is performed using conventional suturing technique.
| Study group | Role | What they receive |
|---|---|---|
| Purse String Technique | Experimental | Thyroidectomy closure is performed using purse string technique. Receives: Procedure: Purse string technique |
| Conventional technique | Active comparator | Thyroidectomy closure is performed using conventional technique. Receives: Procedure: Conventional technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of scar
Length of scar in milimeter
Measured: 8 to 12 weeks following thyroidectomy
Width of scar
Width of scar in milimeter
Measured: 8 to 12 weeks following thyroidectomy
Wrinkle
Presence of wrinkle
Measured: 8 to 12 weeks following thyroidectomy
Patient's satisfaction
Patient's satisfaction assessed using Likert scale of 1 to 10
Measured: 8 to 12 weeks following thyroidectomy
Secondary outcomes (3)
Duration of surgery
Duration of surgery in minutes
Measured: During surgery
Bleeding
Volume of bleeding during surgery in cc
Measured: During surgery
Post operative hospital stay
Post operative hospital stay
Measured: 1 week following thyroidectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study start1 Oct 2013
- Primary completion31 Dec 2014
- Study completion31 Dec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized controlled study
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dr Cipto Mangunkusumo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Kurnia, Dr Cipto Mangunkusumo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035383
- Sponsor's protocol ID
- DCiptoMGHAKurnia
- Status last verified
- Jan 2017
- First submitted
- 22 Jan 2017
- Last updated
- 30 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Purse String Suture for the Closure of Large Thyroidectomy Resulted in Better Cosmetics
- ClinicalTrials.gov ID
- NCT03035383
- Acronym / sponsor ID
- DCiptoMGHAKurnia
- Conditions
- Thyroidectomy
- Keywords
- Large thyroid, purse string suture, thyroidectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
- Study start
- 1 Oct 2013 (actual)
- Primary completion
- 31 Dec 2014 (actual)
- Study completion
- 31 Dec 2014 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| Purse String Technique | Experimental | Procedure: Purse string techniqueThyroidectomy closure is performed using purse string technique. |
| Conventional technique | Active comparator | Procedure: Conventional techniqueThyroidectomy closure is performed using conventional technique. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- New cases of thyroid tumor in Doctor Cipto Mangunkusumo General Hospital
- Tumor diameter > 6 cm
Key exclusion criteria (2 listed)
- Previous surgery in the anterior neck area
- Local involvement of lymph nodes requiring nodes dissection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Purse string techniqueAlso: PSTThyroidectomy closure is performed using purse string suturing technique. | Procedure or surgery | Purse String Technique |
| Conventional techniqueAlso: CTThyroidectomy closure is performed using conventional suturing technique. | Procedure or surgery | Conventional technique |
Primary outcome
Length of scar
Time frame: 8 to 12 weeks following thyroidectomy
Length of scar in milimeter
Width of scar
Time frame: 8 to 12 weeks following thyroidectomy
Width of scar in milimeter
Wrinkle
Time frame: 8 to 12 weeks following thyroidectomy
Presence of wrinkle
Patient's satisfaction
Time frame: 8 to 12 weeks following thyroidectomy
Patient's satisfaction assessed using Likert scale of 1 to 10
3 secondary outcomes
Duration of surgery
Time frame: During surgery
Bleeding
Time frame: During surgery
Post operative hospital stay
Time frame: 1 week following thyroidectomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2017.
- Individual participant dataSharing planned: No. No plan to share IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Purse string technique and Conventional technique in people with Thyroidectomy, run by Dr Cipto Mangunkusumo General Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of scar (time frame: 8 to 12 weeks following thyroidectomy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2017.