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Thyroid Cosmesis Study at St. Paul's Hospital, Vancouver BC

2015-06-05 00:38:21 | BioPortfolio

Summary

This study looks at the difference in surgical scar outcomes between two different surgical incision methods during thyroid surgery: scalpel vs electrocautery. Patients who are already scheduled for thyroid surgery with Dr. Sam Wiseman, Endocrine Surgeon at St. Paul's Hospital, and that meet the eligibility criteria for this study will be invited to participate. After signing the informed consent form, participants will be randomized into either one of the two incision methods, but will not know which one they receive. There will be two follow-up time points: one at 6 and another at 12 months post-operative. At these time points the research team will send a letter to the participant asking them to rate the appearance of their surgical scar. They will also be asked to take a picture of their scar and send it back to the research team, so that the research team can make an assessment of their surgical scar. The study concludes when the 12 month follow-up is complete.

Description

Purpose:

To evaluates the difference in thyroid cosmesis between two different surgical incision methods during thyroidectomy: scalpel vs electrocautery.

Hypotheses:

The investigators' hypotheses is that there is no difference in the cosmetic outcome of surgical incision during thyroidectomy by either a scalpel or electrocautery.

Justification:

Very few studies have addressed whether electrocautery produces a cosmetically inferior surgical scar in an objective manner. While some studies have commented briefly on the cosmesis of electrocautery scars, only one previous randomized clinical trials to date have evaluated the cosmesis of electrocautery and scalpel incisions using a validated scar assessment tool. In this study, Chau et al. found that after 6 months postoperatively there was no difference in objective cosmetic outcome or subjective patient satisfaction between the two techniques. This study was a relatively smaller trial, evaluating a total of 38 incisions, thus a larger scale study would be warranted.

A further advantage of electrocautery over scalpels is the decreased risk of surgical injuries. Approximately 17% of all surgical sharps injuries are due to scalpel blades, while only 2% were associated with electrocautery devices. As awareness and concern over blood born diseases increases, further efforts to reduce sharp injuries including replacing scalpels with electrocautery when possible should be investigated.

Objectives:

Aim 1: To compare the cosmetic outcome of surgical scars resulting from scalpel and electrocautery incisions.

Aim 2: To determine rates of wound infection associated with each technique.

Aim 3: To assess if electrocautery incisions are associated with a difference in postoperative pain compared to incisions made by a scalpel.

Research Method:

Patients who are already scheduled for thyroid surgery with Dr. Sam Wiseman at St. Paul's Hospital in Vancouver, BC, and that meet the eligibility criteria for this study will be invited to participate. After signing the informed consent form, participants will be randomized into either one of the two incision methods, but will be blinded as to which one they receive. There will be two follow-up time points: one at 6 months and another at 12 months postoperative. At these time points the research team will send a letter to the participant asking them to rate the appearance of their surgical scar, rate of their wound infection and the degree of their post operative pain using the Patient Observer Scar Assessment Scale (POSAS). They will also be asked to take a picture of their scar and send it back to the research team so the research team can make a similar assessment.

Statistical Analysis:

Once the research team receives the participant's questionnaire and photo, the images of their surgical scars will be evaluated by independent, trained, and blinded observers who will use the Patient Observer Scar Assessment Scale (POSAS) and the Vancouver Scar Scale (VSS) to evaluate the cosmesis of the surgical scar. The participants questionnaires will also be evaluated by the surgical team to assess Objective: Aim #3. The study concludes when the 12 month follow-up and these assessment by the research team is complete.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject)

Conditions

Surgery

Intervention

Scalpel, Electrocautery

Location

St. Paul's Hospital
Vancouver
British Columbia
Canada
v6z1y6

Status

Recruiting

Source

St. Paul's Hospital, Canada

Results (where available)

View Results

Links

Published on BioPortfolio: 2015-06-05T00:38:21-0400

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Medical and Biotech [MESH] Definitions

Procedures using an electrically heated wire or scalpel to treat hemorrhage (e.g., bleeding ulcers) and to ablate tumors, mucosal lesions, and refractory arrhythmias. It is different from ELECTROSURGERY which is used more for cutting tissue than destroying and in which the patient is part of the electric circuit.

Surgical procedures conducted with the aid of computers. This is most frequently used in orthopedic and laparoscopic surgery for implant placement and instrument guidance. Image-guided surgery interactively combines prior CT scans or MRI images with real-time video.

Surgery which could be postponed or not done at all without danger to the patient. Elective surgery includes procedures to correct non-life-threatening medical problems as well as to alleviate conditions causing psychological stress or other potential risk to patients, e.g., cosmetic or contraceptive surgery.

Surgery which could be postponed or not done at all without danger to the patient. Elective surgery includes procedures to correct non-life-threatening medical problems as well as to alleviate conditions causing psychological stress or other potential risk to patients, e.g., cosmetic or contraceptive surgery.

Endoscopic surgical procedures performed with visualization via video transmission. When real-time video is combined interactively with prior CT scans or MRI images, this is called image-guided surgery (see SURGERY, COMPUTER-ASSISTED).

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