A Study Into the Effect of Seprafilm in Open Total Thyroidectomy

National Cancer Centre, Singapore

Status

Terminated

Conditions

Thyroid Carcinoma

Treatments

Device: Seprafilm (Sanofi, USA)

Study type

Interventional

Funder types

Other

Identifiers

NCT01865838

Seprafilm in Thyroidectomy

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

21 to 75 years old

Volunteers

No Healthy Volunteers

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