Postoperative Distress and Cosmetic Outcomes After Open Versus Robotic Thyroidectomy

NCT01075269 | Unknown DMC

• 1 other identifier: KoreanAES001
• Study Type: observational
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Thyroidectomy; Distress; Surgery

Keywords

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

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (1)

• Subjective voice and swallowing evaluation

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

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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).

You may qualify if:

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

You may not qualify if:

• (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)

Sponsors & Collaborators

• Korean Association of Endocrine Surgeons: lead

Study Sites (1)

Ajou University Medical Center, Department of Surgery

Suwon, 443-721, South Korea

Location

Study Officials

• Jandee Lee, MD

  Korean Association of Endocrine Surgeons

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK

Study Record Dates

• First Submitted: February 23, 2010
• First Posted: February 25, 2010
• Study Start: April 1, 2009
• Primary Completion: February 1, 2010
• Study Completion: May 1, 2010
• Last Updated: February 25, 2010

Record last verified: 2010-02

Locations

KR (1)