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A Study Into the Effect of Seprafilm in Open Total Thyroidectomy

NCT01865838 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2017-04-12

No results posted yet for this study

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.

Conditions

  • Thyroid Carcinoma

Interventions

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.

Sponsors & Collaborators

  • Singapore General Hospital

    collaborator OTHER

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Khoon H Tan, MBBS, PhD · National Cancer Centre, Singapore

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2014-09-30
Completion
2014-09-30

Countries

  • Singapore

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01865838 on ClinicalTrials.gov