A Study Into the Effect of Seprafilm in Open Total Thyroidectomy

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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