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A Study Into the Effect of Seprafilm in Open Total Thyroidectomy

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ClinicalTrials.gov Identifier: NCT01865838
Recruitment Status : Terminated (safety issue)
First Posted : May 31, 2013
Last Update Posted : April 12, 2017
Sponsor:
Collaborator:
Singapore General Hospital
Information provided by (Responsible Party):
National Cancer Centre, Singapore

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.

Condition or disease Intervention/treatment Phase
Thyroid Carcinoma Device: Seprafilm (Sanofi, USA) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Study Into the Effect of Seprafilm on Post Operative Adhesions After Open Total Thyroidectomy.
Study Start Date : May 2013
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Arm Intervention/treatment
Active Comparator: Seprafilm (Sanofi, USA)
Patients in this arm received Seprafilm during surgery.
Device: Seprafilm (Sanofi, USA)
Studies have unequivocally shown that Seprafilm is effective in reducing internal adhesion formation after abdominal surgery. In a large scaled randomized controlled trial involving about 1700 patients, Fazio et al. found that the use or Seprafilm reduces the risk of small bowel intestinal obstruction which required operative intervention. The safety profile of Seprafilm has also been nicely demonstrated in a randomized controlled trial by Beck et al. in this study, the authors concluded that within the context of abdomino-pelvic surgery, Seprafilm does not increase the incidence of abdominal/pelvic abscesses in patients after abdomino-pelvic surgery; if anything, the anti-adhesive properties of Seprafilm are such that the authors noted an increased risk of anastomotic complications in patients whose bowel anastomoses were in close contact with Seprafilm.

No Intervention: Control
Patients in this arm does NOT receive Seprafilm during surgery.



Primary Outcome Measures :
  1. Cricoid elevation [ Time Frame: 1 to 14 days before the surgery, postop day 14 and 3 months postop ]

    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.


Secondary Outcome Measures :
  1. Hyoid elevation [ Time Frame: 1 to 14 days before the surgery, postop day 14 and 3 months postop ]

    Trial candidates are to undergo videofluoroscopy to assess their swallowing and hyoid 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.

  2. Crico-hyoid distance [ Time Frame: 1 to 14 days before the surgery, postop day 14 and 3 months postop ]

    Trial candidates are to undergo videofluoroscopy to assess their swallowing and hyoid elevation is measured using ImageJ.

    • 1 to 14 days before the surgery
    • Second measurement is 14 days postop.
    • Third measurement is 3 months postop.

  3. Videotaping measurement [ Time Frame: 1 to 14 days before the surgery, postop day 14 and 3 months postop ]

    Trial candidates are to undergo videotaping of their surgical incision site during swallowing. Maximal displacement of the incision site will be measured and recorded using ImageJ.

    • First measurement is 1 to 14 days before the surgery.
    • Second measurement is 14 days postop.
    • Third measurement is 3 months postop.

  4. Swallowing Quality of Life questionaire [ Time Frame: 1 to 14 days before the surgery, postop day 14 and 3 months postop ]

    Trial candidates will be interviewed regarding their swallowing using the Sydney Swallowing questionnaire. Patients will be interviewed three times.

    • First interview is 1 to 14 days before the surgery.
    • Second interview is 14 days postop.
    • Third interview is 3 months postop.


Other Outcome Measures:
  1. Duration of surgery [ Time Frame: During surgery ]
    -Knife-to-skin time to closure.

  2. Drainage [ Time Frame: Day 1 to Day 3 after the surgery ]
    -Surgical drain will be placed for patients at surgeons' discretion. Drain amount will be recorded.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01865838


Locations
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Singapore
Singapore General Hospital
Singapore, Singapore, 169608
National Cancer Centre Singapore
Singapore, Singapore, 169610
Sponsors and Collaborators
National Cancer Centre, Singapore
Singapore General Hospital
Investigators
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Principal Investigator: Khoon H Tan, MBBS, PhD National Cancer Centre, Singapore

Publications:
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Responsible Party: National Cancer Centre, Singapore
ClinicalTrials.gov Identifier: NCT01865838     History of Changes
Other Study ID Numbers: Seprafilm in Thyroidectomy
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Keywords provided by National Cancer Centre, Singapore:
Total thyroidectomy
Seprafilm
Swallowing difficulty post thyroidectomy
Additional relevant MeSH terms:
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Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Endocrine System Diseases
Thyroid Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents