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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2010 by Korean Association of Endocrine Surgeons.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Korean Association of Endocrine Surgeons
ClinicalTrials.gov Identifier:
NCT01075269
First received: February 23, 2010
Last updated: February 24, 2010
Last verified: February 2010
  Purpose

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.


Condition
Thyroidectomy
Distress
Surgery

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 ] [ Designated as safety issue: Yes ]

    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. ] [ Designated as safety issue: Yes ]

    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)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
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).

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01075269

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

No publications provided

Responsible Party: Ajou university medical center, department of surgery, Korean Association of Endocrine Surgeons
ClinicalTrials.gov Identifier: NCT01075269     History of Changes
Other Study ID Numbers: KoreanAES001
Study First Received: February 23, 2010
Last Updated: February 24, 2010
Health Authority: Korea: Food and Drug Administration

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

ClinicalTrials.gov processed this record on October 21, 2014