Postoperative Distress and Cosmetic Outcomes After Open Versus Robotic Thyroidectomy (Robot1)
Recruitment status was Active, not recruiting
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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 |
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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. |
- 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.
- 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 |
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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.
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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.
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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 |
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| Korea, Republic of | |
| Ajou University Medical Center, Department of Surgery | |
| Suwon, Korea, Republic of, 443-721 | |
| 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 May 19, 2013