NCT01865838

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

May 14, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

May 31, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2014

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

1.3 years

First QC Date

May 14, 2013

Last Update Submit

April 10, 2017

Conditions

Thyroid Carcinoma

Keywords

Total thyroidectomySeprafilmSwallowing difficulty post thyroidectomy

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (4)

  • Hyoid elevation

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

  • Crico-hyoid distance

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

  • Videotaping measurement

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

  • Swallowing Quality of Life questionaire

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

Other Outcomes (2)

  • Duration of surgery

    During surgery

  • Drainage

    Day 1 to Day 3 after the surgery

Study Arms (2)

Seprafilm (Sanofi, USA)

ACTIVE COMPARATOR

Patients in this arm received Seprafilm during surgery.

Device: Seprafilm (Sanofi, USA)

Control

NO INTERVENTION

Patients in this arm does NOT receive Seprafilm during surgery.

Interventions

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.

Seprafilm (Sanofi, USA)

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Singapore General Hospital

Singapore, 169608, Singapore

Location

National Cancer Centre Singapore

Singapore, 169610, Singapore

Location

Related Publications (4)

  • 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.

    PMID: 16320005BACKGROUND

  • 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.

    PMID: 14530667BACKGROUND

  • 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.

    PMID: 20497879BACKGROUND

  • 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.

    PMID: 18660685BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Khoon H Tan, MBBS, PhD

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2013

First Posted

May 31, 2013

Study Start

May 1, 2013

Primary Completion

September 1, 2014

Study Completion

September 1, 2014

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

SG(2)