A Study Into the Effect of Seprafilm on Post Operative Adhesions After Open Total Thyroidectomy.
21 Years
75 Years
Both
Focus of Study: Prevent Pulling Sensation and/or Swallowing Difficulty in Patients Received Total Thyroidectomy.
Trial Information
A Study Into the Effect of Seprafilm on Post Operative Adhesions After Open Total Thyroidectomy.
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Outcome Measure:
Cricoid elevation
Outcome Description:
Trial candidates are to undergo videofluoroscopy to assess their swallowing and cricoid elevation is measured using ImageJ. First measurement is 1 to 14 days before the surgery. Second measurement is 14 days postop. Third measurement is 3 months postop.
Outcome Time Frame:
1 to 14 days before the surgery, postop day 14 and 3 months postop
Safety Issue:
No
Principal Investigator
Khoon H Tan, MBBS, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
National Cancer Centre, Singapore
Authority:
Singapore: Clinical Trials & Epidemiology Research Unit (CTERU)
Study ID:
Seprafilm in Thyroidectomy
NCT ID:
NCT01865838
Start Date:
May 2013
Completion Date:
August 2014
Related Keywords:
- Focus of Study: Prevent Pulling Sensation and/or Swallowing Difficulty in Patients Received Total Thyroidectomy.
- Total thyroidectomy
- Seprafilm
- Swallowing difficulty post thyroidectomy
- Deglutition Disorders
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