Influence of Thyroid Hormones on the Woundhealing Process

Not Applicable

• Conditions: Thyroid Neoplasms; Thyroid Carcinoma
• Interventions: Procedure: blood sampling

• Registration Number: NCT00929318
• Lead Sponsor: Hannover Medical School

Brief Summary

Main goal of this clinical investigation is to investigate different cytokines in wound fluids of euthyroid vs. hypothyroid patients. As a primary endpoint we want to evaluate if different cytokine levels in euthyroid vs. hypothyroid patients exist and to what extent these cytokines differ. Our targeted cytokines are: IL6, IL10, TNFa and MCP-1. From the literature these 4 factors seem to be the most reasonable to measure and to focus on. Additionally we focus on these 4 factors for financial reasons, technically there wouldn't be a problem to measure more, which is correlated with higher costs. Besides, more than 6 factors would mean larger amounts of sample fluids needed, which would cause technical problems. These factors don't have to change in the same direction. Secondarily, we believe that differences in cytokine profiles of hypothyroidism vs. euthyroidism will correlate to differences in duration and clinical characteristics of the wound healing process.

Detailed Description

Not available

Study Timeline

• Status Verified: 2009-06
• Study Start: 2009-06
• Study First Submitted: 2009-06-26
• Study First Submitted QC: 2009-06-26
• Last Update Submitted: 2009-06-26
• Study First Posted: 2009-06-29
• Last Update Posted: 2009-06-29
• Primary Completion: 2009-12
• Study Completion: 2010-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 26

Inclusion Criteria

• Near total or total thyroidectomy because of struma multinodsa (nodular goiter) with or without substitution of thyroid hormone after operation
• Total thyroidectomy because of papillary carcinoma of thyroid gland (T1/T2 carcinoma, N1, M0) with planned radio-ablative therapy (RAT) without or with rhTSH

Exclusion Criteria

• Pat< 18 years
• Immune disease of thyroid gland (Graves disease)
• Severe immunodeficiency
• Immunosuppressive medication because of solid Organ transplantation
• Hepatitis A/B/C or HIV
• All exclusion criteria for any surgical procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
benign	blood sampling	patients after surgery because of a benign disease
DTC	blood sampling	Patients after thyroidectomy because of papillary carcinoma of the thyroid gland

Primary Outcome Measures

Name	Time	Method
Evidence for different cytokine levels in euthyroid vs hypothyroid condition confirmed by bood serum samples	21 days after surgery

Secondary Outcome Measures

Name	Time	Method
Differences in duration and clinical characteristics of the wound healing process verified by a modified ASEPSIS score.	21 days after surgery

Trial Locations

Locations (1)

Medizinische Hoochschule Hannover, Allgemein-, Viszeral-und Transplantationscirurgie OE 6220; 🇩🇪 Hannover, Germany