Clinical trial · Interventional
A Study Into the Effect of Seprafilm in Open Total Thyroidectomy
A Study Into the Effect of Seprafilm on Post Operative Adhesions After Open Total Thyroidectomy.
NCT01865838CI-TRIAL-00026942terminatedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): safety issue
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroid Carcinoma | Thyroid Gland Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Seprafilm (Sanofi, USA) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Seprafilm (Sanofi, USA)
- description
- Patients in this arm received Seprafilm during surgery.
- interventionNames
- Device: Seprafilm (Sanofi, USA)
- type
- NO_INTERVENTION
- label
- Control
- description
- Patients in this arm does NOT receive Seprafilm during surgery.
Primary outcomes (1)
- measure
- Cricoid elevation
- timeFrame
- 1 to 14 days before the surgery, postop day 14 and 3 months postop
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDFazio 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 16320005
- BACKGROUNDBeck 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 14530667
- BACKGROUNDPark 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 20497879
- BACKGROUNDMetwally 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 18660685