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Thyroid CarcinomaNCT01865838

A Study Into the Effect of Seprafilm in Open Total Thyroidectomy

A study testing Seprafilm (Sanofi, USA) in people with Thyroid Carcinoma, run by National Cancer Centre, Singapore at 2 sites in Singapore.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Thyroid Carcinoma
What is being tested?
Seprafilm (Sanofi, USA)
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
2 sitesSingapore
Study dates
May 2013to Sep 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

2 sites in 1 country.

Singapore2 sites

  • Singapore General Hospital

    Singapore, 169608

  • National Cancer Centre Singapore

    Singapore, 169610

Other trials in Singapore

About this study

Official title: A Study Into the Effect of Seprafilm on Post Operative Adhesions After Open Total Thyroidectomy.

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.

Read the 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.

Being tested
Seprafilm (Sanofi, USA)
Keywords
Total thyroidectomy, Seprafilm, Swallowing difficulty post thyroidectomy
Medical subject headings
Thyroid Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Seprafilm (Sanofi, USA)Device

    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.

Study groups in NCT01865838
Study groupRoleWhat they receive
Seprafilm (Sanofi, USA)Active comparatorPatients in this arm received Seprafilm during surgery.
Receives: Device: Seprafilm (Sanofi, USA)
ControlNo interventionPatients in this arm does NOT receive Seprafilm during surgery.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cricoid elevation

    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.

    Measured: 1 to 14 days before the surgery, postop day 14 and 3 months postop

Secondary outcomes (4)

  1. Hyoid elevation

    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.

    Measured: 1 to 14 days before the surgery, postop day 14 and 3 months postop

  2. Crico-hyoid distance

    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.

    Measured: 1 to 14 days before the surgery, postop day 14 and 3 months postop

  3. Videotaping measurement

    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.

    Measured: 1 to 14 days before the surgery, postop day 14 and 3 months postop

  4. Swallowing Quality of Life questionaire

    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.

    Measured: 1 to 14 days before the surgery, postop day 14 and 3 months postop

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2013 (estimated)
  2. Study startMay 2013
  3. Primary completionSep 2014
  4. Study completionSep 2014

Why it stopped: safety issue

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01865838
Sponsor's protocol ID
Seprafilm in Thyroidectomy
Status last verified
Apr 2017
First submitted
14 May 2013
Last updated
12 Apr 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • Fazio VW, Cohen Z, Fleshman JW, van Goor H, Bauer JJ, Wolff BG, Corman M, Beart RW Jr, Wexner SD, Becker JM, Monson JR, Kaufman HS, Beck DE, Bailey HR, Ludwig KA, Stamos MJ, Darzi A, Bleday R, Dorazio R, Madoff RD, Smith LE, Gearhart S, Lillemoe K, Gohl J. Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection. Dis Colon Rectum. 2006 Jan;49(1):1-11. doi: 10.1007/s10350-005-0268-5.

    PubMed 16320005

  • Beck DE, Cohen Z, Fleshman JW, Kaufman HS, van Goor H, Wolff BG; Adhesion Study Group Steering Committee. A prospective, randomized, multicenter, controlled study of the safety of Seprafilm adhesion barrier in abdominopelvic surgery of the intestine. Dis Colon Rectum. 2003 Oct;46(10):1310-9. doi: 10.1007/s10350-004-6739-2.

    PubMed 14530667

  • Park WS, Chung YS, Lee KE, Kim HY, Choe JH, Koh SH, Youn YK. Anti-adhesive effect and safety of sodium hyaluronate and sodium carboxymethyl cellulose solution in thyroid surgery. Asian J Surg. 2010 Jan;33(1):25-30. doi: 10.1016/S1015-9584(10)60005-X.

    PubMed 20497879

  • Metwally M, Cheong Y, Li TC. A review of techniques for adhesion prevention after gynaecological surgery. Curr Opin Obstet Gynecol. 2008 Aug;20(4):345-52. doi: 10.1097/GCO.0b013e3283073a6c.

    PubMed 18660685

Questions about this trial

What is this clinical trial studying?

A study testing Seprafilm (Sanofi, USA) in people with Thyroid Carcinoma, run by National Cancer Centre, Singapore at 2 sites in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 12 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: safety issue). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cricoid elevation (time frame: 1 to 14 days before the surgery, postop day 14 and 3 months postop). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01865838, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2017.

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