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ThyroidectomyRobot1NCT01075269

Postoperative Distress and Cosmetic Outcomes After Open Versus Robotic Thyroidectomy

An observational study of Thyroidectomy and Distress, run by Korean Association of Endocrine Surgeons at 1 site in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Robotic assistance during thyroid surgery has been utilized clinically in Korea since late 2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid gland. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Thyroidectomy, Distress, Surgery
How many people
84 participants
Where
1 siteSouth Korea
Study dates
Apr 2009to May 2010
Phase
Observational
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 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Study population: Patients with differentiated thyroid carcinoma who were scheduled to underwent thyroidectomy in Ajou University Medical center (Tertial oncologic center).

Who may be able to join

  • (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or
  • (b) a papillary thyroid carcinoma ≤2 cm in diameter.

Who cannot join

  • (a) previous neck operations;
  • (b) age <21 or >65 years;
  • (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy;
  • (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or
  • (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN)

Trial locations and contacts

1 site in 1 country.

South Korea1 site
  • Ajou University Medical Center, Department of Surgery

    Suwon, 443-721

Other trials in South Korea

About this study

Official title: Does Robotic Assistance Significantly Reduce Postoperative Distress and Patient Complaints About Cosmetic Outcomes After Thyroid Surgery? A Preliminary Report.

Robotic assistance during thyroid surgery has been utilized clinically in Korea since late 2007. Robotic thyroidectomy has also been validated for surgical management of the thyroid gland. Compared with endoscopic thyroidectomy, the use of a robot in an endoscopic approach via the axilla provides a broader view of the thyroid bed, albeit from a lateral, as opposed to the conventional anterior, perspective. The wrist action of a surgical robot also provides a greater degree of movement than afforded by the use of simple endoscopic instruments, and tremor is eliminated.

Although several reports on operative outcomes of the robotic technique have appeared, no prospective trials comparing the clinical results of robotic with conventional open thyroidectomy have been described. We therefore designed a prospective trial comparing outcomes, including postoperative distress and patient satisfaction, between patients undergoing robotic and conventional open thyroidectomy.

Read the detailed description

Patient assessment A prospective study addressing perioperative outcomes and postoperative patient discomfort after thyroidectomy was commenced in April 2009 and is currently continuing. All patients were told about the operative techniques involved in conventional open and robotic thyroidectomy, and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent. The study protocol was approved by our Institutional Review Board.

Patients were included if they had (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or (b) a papillary thyroid carcinoma ≤2 cm in diameter. Exclusion criteria included (a) previous neck operations; (b) age <21 or >65 years; (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy; (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN). The extent of thyroid resection was determined for each patient using American Thyroid Association guidelines. All patients underwent prophylactic ipsilateral central compartment node dissection (CCND; pretracheal, prelaryngeal, and paraesophageal).

Surgical outcomes Surgical outcomes included operating time, intraoperative blood loss, number of retrieved central lymph nodes, length of hospital stay, and postoperative complications. We also assessed the incidence of postoperative seromas and hematomas for at least 3 weeks postoperatively. Operating time was defined as the interval from skin incision to closure. The drainage extent was measured over 24 h, and a drain was removed if drainage was <30 mL in this interval. Study patients were discharged the day after drain removal.

Mobility of the vocal cords was assessed by videostrobolaryngoscopic examination, performed both preoperatively and 1 week and 3 months postoperatively. Vocal cord palsy was defined as permanent when there was no evidence of recovery within 6 months.

Postoperative pain and cosmetic outcomes To evaluate the degree of postoperative pain, all patients were given analgesics on an identical protocol. Patients were asked to grade postoperative pain in the neck and anterior chest as none, very slight, slight, moderate, or severe, 24 h after surgery.

At 1 week and 3 months after surgery, patients were asked (by questionnaire) to evaluate the presence of hyperesthesia and paresthesia in the neck and anterior chest, as well as shoulder discomfort. All patients answered and returned completed questionnaires.

Cosmetic results, including wound appearance and complaints, were evaluated by patients 3 months after surgery using a verbal response scale with five possible responses: extremely satisfied, excellent, acceptable, dissatisfied, and extremely dissatisfied.

Subjective voice and swallowing evaluation We used the Voice Handicap Index-10 (VHI-10), a validated, reliable self-assessment tool that measures patient assessment of voice quality and the effect of voice on quality-of-life, to determine the frequency of voice abnormalities. The VHI-10 consists of 10 questions, responses to each of which are scaled from a minimum of 0 (no voice alteration) to a maximum of 40 (highest voice impairment).

Swallowing difficulties were assessed using the Swallowing Impairment Index (SIS-6), a self-administered, six-item assessment of symptoms related to dysphagia that has been validated for diagnosis of impairment. The scoring of each item on the SIS-6 ranges from a minimum of 0 (no swallowing alteration) to a maximum of 24 (highest swallowing impairment). The SIS-6 score is also excellent for assessing non-voice throat symptoms, including cough, choking, and throat-clearing, all of which occur after thyroidectomy. All patients enrolled in this study completed the VHI-10 and SIS-6 questionnaires before surgery and at 1 week and 3 months after surgery.

Keywords
robotic thyroidectomy, comparative study, cosmetic result, postoperative neck discomfort, swallowing symptom, Robotic thyroidectomy, cosmetic effect, postoperative distress, surgical outcome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01075269
Study groupRoleWhat they receive
Conventional open thyroidectomy groupAll patients were told about the operative techniques involved in conventional open and robotic thyroidectomy, and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.
Robotic thyroidectomy groupAll patients were told about the operative techniques involved in conventional open and robotic thyroidectomy, and patients subsequently chose their preferred surgical procedure, voluntarily agreed to participate in our study, and provided written informed consent.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Surgical outcomes, postoperative pain and cosmetic outcomes

    Surgical outcomes included operating time, intraoperative blood loss, length of hospital stay, and postoperative complications.

    To evaluate the degree of postoperative pain, all patients were given analgesics on an identical protocol. Patients were asked to grade postoperative pain in the neck and anterior chest as none, very slight, slight, moderate, or severe, 24 h after surgery.

    Cosmetic results, including wound appearance and complaints, were evaluated by patients 3 months after surgery using a verbal response scale with five possible responses.

    Measured: Postopeative pain: 24 hours after surgery, Cosmetic outcomes: 3 months after surgery

Secondary outcomes (1)
  1. Subjective voice and swallowing evaluation

    We used the Voice Handicap Index-10 (VHI-10), a validated, reliable self-assessment tool that measures patient assessment of voice quality and the effect of voice on quality-of-life, to determine the frequency of voice abnormalities.

    Swallowing difficulties were assessed using the Swallowing Impairment Index (SIS-6), a self-administered, six-item assessment of symptoms related to dysphagia that has been validated for diagnosis of impairment.

    Measured: before surgery and at 1 week and 3 months after surgery.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2010 (estimated)
  2. Study startApr 2009
  3. Primary completionFeb 2010
  4. Study completionMay 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
84 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01075269
Sponsor's protocol ID
KoreanAES001
Acronym
Robot1
Status last verified
Feb 2010
First submitted
23 Feb 2010
Last updated
25 Feb 2010
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Thyroidectomy and Distress, run by Korean Association of Endocrine Surgeons at 1 site in South Korea.

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 5 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: status not confirmed, as of the sponsor's last update on 25 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Results are not available in the source record.

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?

Surgical outcomes, postoperative pain and cosmetic outcomes (time frame: Postopeative pain: 24 hours after surgery, Cosmetic outcomes: 3 months after surgery). 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 25 Feb 2010.

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