Brief Title
A Study Into the Effect of Seprafilm in Open Total Thyroidectomy
Official Title
A Study Into the Effect of Seprafilm on Post Operative Adhesions After Open Total Thyroidectomy.
Brief Summary
The investigators intend to determine the role of Seprafilm, a popular anti-adhesive agent in minimising internal adhesion formation in the neck after thyroid surgery and therefore reduce swallowing discomfort experienced by patients after surgery.
Detailed Description
Thyroid surgery not only constitutes one of the main pillars in the treatment of thyroid cancers, but is also employed in the management of symptomatic goitres. Occasionally, it is mandated in patients with thyrotoxicosis refractory to medical therapy. While thyroid surgery can be performed with low risks such that patients rarely have to stay beyond three days in hospital, the track record of thyroid surgery is somewhat blemished by the unfortunate side effects associated with the neck scarring after thyroid surgery. Not uncommonly, patients experience discomfort in the neck region after thyroid surgery; in the extreme of cases, patients may even complain of a lifelong pulling sensation in the neck area during eating. The anti-adhesive properties of Seprafilm are well established in animal studies and affirmed by clinical observations in abdominal surgeries that utilize this material. Thus, Seprafilm is routinely used in instances when a surgeon foresees a need to perform abdominal surgery on the same patient in future, or during the fashioning of a temporary stoma. The safety profile of Seprafilm in thyroidectomy has also been shown by a recent study conducted by a group of clinicians in Seoul. We postulate that the application of Seprafilm to the surgical wound towards the end of a thyroidectomy significantly reduces internal adhesion formation in the neck region. By achieving this objective, we hope to improve patients' satisfaction with thyroid surgery in terms of ease of swallowing after surgery.
Study Type
Interventional
Primary Outcome
Cricoid elevation
Secondary Outcome
Hyoid elevation
Condition
Thyroid Carcinoma
Intervention
Seprafilm (Sanofi, USA)
Study Arms / Comparison Groups
Seprafilm (Sanofi, USA)
Description: Patients in this arm received Seprafilm during surgery.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
19
Start Date
May 2013
Completion Date
September 2014
Primary Completion Date
September 2014
Eligibility Criteria
Inclusion Criteria: - Age 21-75 - Histological confirmation of differentiated thyroid cancer requiring surgery, symptomatic goiters, thyroid nodules requiring histological analysis, or thyrotoxicosis poorly controlled by medication. - Undergoing total thyroidectomy Exclusion Criteria: - Previous neck surgery - Previous neck radiotherapy - Patients with a known history of keloids - Patients with a known history of motility disorders in the upper gastrointestinal tract and preexisting swallowing difficulty. - Patients with metastatic disease; patients with disease that would require postop radiation therapy, radionuclide iodine therapy and any adjuvant therapies. - Patients with advanced disease that would require radical or modified neck dissection - Patients with lobe larger than 10 cm, or nodule larger than 8 cm which require extensive dissection that may confound the study - Patients with connective tissue diseases and chronic diseases on long-term medications that may interfere with wound healings such as steroids
Gender
All
Ages
21 Years - 75 Years
Accepts Healthy Volunteers
No
Contacts
Khoon H Tan, MBBS, PhD, ,
Location Countries
Singapore
Location Countries
Singapore
Administrative Informations
NCT ID
NCT01865838
Organization ID
Seprafilm in Thyroidectomy
Responsible Party
Sponsor
Study Sponsor
National Cancer Centre, Singapore
Collaborators
Singapore General Hospital
Study Sponsor
Khoon H Tan, MBBS, PhD, Principal Investigator, National Cancer Centre, Singapore
Verification Date
April 2017