Thyroid Carcinoma Clinical Trial
Official title:
A Study Into the Effect of Seprafilm on Post Operative Adhesions After Open Total Thyroidectomy.
Verified date | April 2017 |
Source | National Cancer Centre, Singapore |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 19 |
Est. completion date | September 2014 |
Est. primary completion date | September 2014 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years to 75 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Singapore | National Cancer Centre Singapore | Singapore | |
Singapore | Singapore General Hospital | Singapore |
Lead Sponsor | Collaborator |
---|---|
National Cancer Centre, Singapore | Singapore General Hospital |
Singapore,
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. — View Citation
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, Göhl J. Reduction in adhesive small-bowel obstruction by Seprafilm adhesion barrier after intestinal resection. Dis Colon Rectum. 2006 Jan;49(1):1-11. — View Citation
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. Review. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Duration of surgery | -Knife-to-skin time to closure. | During surgery | |
Other | Drainage | -Surgical drain will be placed for patients at surgeons' discretion. Drain amount will be recorded. | Day 1 to Day 3 after the surgery | |
Primary | 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 | 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. |
1 to 14 days before the surgery, postop day 14 and 3 months postop | |
Secondary | 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. |
1 to 14 days before the surgery, postop day 14 and 3 months postop | |
Secondary | 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. |
1 to 14 days before the surgery, postop day 14 and 3 months postop | |
Secondary | 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. |
1 to 14 days before the surgery, postop day 14 and 3 months postop |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT02658513 -
Evaluation of Lancet Blood Sampling for Radioiodine Dosimetry in Thyroid Cancer
|
||
Withdrawn |
NCT01707056 -
The Effect of Coffee on the Absorption of Thyroid Hormone in Patients With Thyroid Carcinoma
|
N/A | |
Completed |
NCT00215605 -
Study of XL184 (Cabozantinib) in Adults With Advanced Malignancies
|
Phase 1 | |
Completed |
NCT06439745 -
More Than 50% of the Patients With Clinically Unifocal T1b/Small T2 Node Negative Papillary Thyroid Carcinoma Scheduled for Thyroid Lobectomy May Require Completion Thyroidectomy if the Nodal Status is Evaluated
|
||
Terminated |
NCT04327999 -
Effect of Artificial Tears on Radioiodine Levels in the Nasolacrimal Duct System
|
Phase 2 | |
Completed |
NCT02194920 -
Parathyroid Reimplantation in Forearm Subcutaneous Tissue During Thyroidectomy: a Simple Way to Avoid Ipoparathyroidism and Evaluate Graft Function
|
N/A | |
Enrolling by invitation |
NCT06095362 -
Thyroid Cancer and Central Lymph Node Metastases Detection Using Bevacizumab-IRDye800CW
|
Phase 1 | |
Not yet recruiting |
NCT05949424 -
OPTI - DOSE: Optimal Dosing of Oral Anticancer Drugs in Older Adults
|
Phase 4 | |
Active, not recruiting |
NCT02145143 -
Enhancing Radioiodine (RAI) Incorporation Into BRAF Mutant, RAI-Refractory Thyroid Cancers With the BRAF Inhibitor Vemurafenib: A Pilot Study
|
N/A | |
Recruiting |
NCT00749697 -
Radioiodine Dosimetry Protocol for Thyroid Cancer Metastases
|
N/A | |
Enrolling by invitation |
NCT04411290 -
Malignancy Predictors, Bethesda and TI-RADS Scores Correlated With Final Histopathology in Thyroid Diseases
|
||
Completed |
NCT01813136 -
Phase II Study of the Optimal Scheme of Administration of Pazopanib in Thyroid Carcinoma
|
Phase 2 | |
Recruiting |
NCT05668962 -
Restor. I-131 Upt. + Selpercatinib in RET F-P RAI-R TC
|
Phase 2 | |
Active, not recruiting |
NCT02185560 -
Prospective, Non-interventional, Post-authorization Safety Study That Includes All Patients Diagnosed as Unresectable Differentiated Thyroid Carcinoma and Treated With Sorafenib
|
||
Completed |
NCT04462471 -
Vemurafenib Plus Copanlisib in Radioiodine-Refractory (RAIR) Thyroid Cancers
|
Phase 1 | |
Completed |
NCT01433809 -
Biomarkers to Distinguish Benign From Malignant Thyroid Neoplasm
|
N/A | |
Recruiting |
NCT00929318 -
Influence of Thyroid Hormones on the Woundhealing Process
|
N/A | |
Completed |
NCT05178186 -
Impact of the COVID-19 Pandemic on Surgery for Thyroid Cancer
|
N/A | |
Completed |
NCT02773667 -
Renal Tracer Elimination in Thyroid Cancer Patients Treated With 131-Iodine
|
||
Not yet recruiting |
NCT00993837 -
Feasibility of Endoscopic Thyroidectomy for Thyroid Carcinoma
|
N/A |