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Postoperative Distress and Cosmetic Outcomes After Open Versus Robotic Thyroidectomy (Robot1)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by Korean Association of Endocrine Surgeons.
Recruitment status was:  Active, not recruiting
Information provided by:
Korean Association of Endocrine Surgeons Identifier:
First received: February 23, 2010
Last updated: February 24, 2010
Last verified: February 2010

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.


Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Does Robotic Assistance Significantly Reduce Postoperative Distress and Patient Complaints About Cosmetic Outcomes After Thyroid Surgery? A Preliminary Report.

Resource links provided by NLM:

Further study details as provided by Korean Association of Endocrine Surgeons:

Primary Outcome Measures:
  • Surgical outcomes, postoperative pain and cosmetic outcomes [ Time Frame: Postopeative pain: 24 hours after surgery, Cosmetic outcomes: 3 months after surgery ]

    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.

Secondary Outcome Measures:
  • Subjective voice and swallowing evaluation [ Time Frame: before surgery and at 1 week and 3 months after surgery. ]

    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.

Enrollment: 84
Study Start Date: April 2009
Estimated Study Completion Date: May 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Conventional open thyroidectomy group
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.
Robotic thyroidectomy group
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.

  Show Detailed Description


Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with differentiated thyroid carcinoma who were scheduled to underwent thyroidectomy in Ajou University Medical center (Tertial oncologic center).

Inclusion Criteria:

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

Exclusion Criteria:

  • (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)
  Contacts and Locations
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Please refer to this study by its identifier: NCT01075269

Korea, Republic of
Ajou University Medical Center, Department of Surgery
Suwon, Korea, Republic of, 443-721
Sponsors and Collaborators
Korean Association of Endocrine Surgeons
Principal Investigator: Jandee Lee, MD Korean Association of Endocrine Surgeons
  More Information

Responsible Party: Ajou university medical center, department of surgery, Korean Association of Endocrine Surgeons Identifier: NCT01075269     History of Changes
Other Study ID Numbers: KoreanAES001
Study First Received: February 23, 2010
Last Updated: February 24, 2010

Keywords provided by Korean Association of Endocrine Surgeons:
robotic thyroidectomy, comparative study, cosmetic result, postoperative neck discomfort, swallowing symptom
Robotic thyroidectomy, cosmetic effect, postoperative distress, surgical outcome processed this record on May 24, 2017