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.

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.

Study Overview

• Status: Terminated
• Conditions: Thyroid Carcinoma
• Intervention / Treatment: Device: Seprafilm (Sanofi, USA)

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.

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169608
    • Singapore General Hospital
  • Singapore, Singapore, 169610
    • National Cancer Centre Singapore

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Seprafilm (Sanofi, USA); Patients in this arm received Seprafilm during surgery.	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.
No Intervention: Control; Patients in this arm does NOT receive Seprafilm during surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgery	-Knife-to-skin time to closure.	During surgery
Drainage	-Surgical drain will be placed for patients at surgeons' discretion. Drain amount will be recorded.	Day 1 to Day 3 after the surgery

Collaborators and Investigators

• Sponsor: National Cancer Centre, Singapore
• Collaborators: Singapore General Hospital
• Investigators: Principal Investigator: Khoon H Tan, MBBS, PhD, National Cancer Centre, Singapore

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: May 14, 2013
• First Submitted That Met QC Criteria: May 28, 2013
• First Posted (Estimate): May 31, 2013

Study Record Updates

• Last Update Posted (Actual): April 12, 2017
• Last Update Submitted That Met QC Criteria: April 10, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Total thyroidectomy; Seprafilm; Swallowing difficulty post thyroidectomy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Endocrine System Diseases; Endocrine Gland Neoplasms; Thyroid Diseases; Head and Neck Neoplasms; Thyroid Neoplasms
• Other Study ID Numbers: Seprafilm in Thyroidectomy