Clinical trial NCT01865838: A Study Into the Effect of Seprafilm in Open Total Thyroidectomy
Official title: A Study Into the Effect of Seprafilm on Post Operative Adhesions After Open Total Thyroidectomy.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Thyroid Carcinoma
Keywords: Total thyroidectomy
Seprafilm
Swallowing difficulty post thyroidectomy
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2013-05-31
Enrollment: 19
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Cricoid elevation
timeFrame: 1 to 14 days before the surgery, postop day 14 and 3 months postop
Secondary outcomes:
measure: Hyoid elevation
timeFrame: 1 to 14 days before the surgery, postop day 14 and 3 months postop
measure: Crico-hyoid distance
timeFrame: 1 to 14 days before the surgery, postop day 14 and 3 months postop
measure: Videotaping measurement
timeFrame: 1 to 14 days before the surgery, postop day 14 and 3 months postop
measure: Swallowing Quality of Life questionaire
timeFrame: 1 to 14 days before the surgery, postop day 14 and 3 months postop
Other outcomes:
measure: Duration of surgery
timeFrame: During surgery
measure: Drainage
timeFrame: Day 1 to Day 3 after the surgery
Locations:
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Khoon H Tan, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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, 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.
citation: 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.
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.
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.