Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications

In all thyroid surgeries, many surgeons utilize drains on a regular basis and have done so for years according to recommendations. Due to the thyroid's high vascularization throughout its endocrine function, any haemorrhage inside the closed paratracheal space has the potential to impede venous and lymphatic drainage, which might result in airway blockage and laryngopharyngeal oedema. Surgeons routinely perform post-operative thyroid gland draining in the modern surgical field. The goal is to stop fluid from accumulating in the surgical wound site, which could constrict the patient's trachea and jeopardize their life.

Thyroid storm, hypocalcemia, hematoma/haemorrhage impairing airway, recurrent or superior laryngeal nerve damage, and wound problems such as wound infection are among the main post-operative consequences of thyroid surgery.

Some reports indicate the use of drains following thyroid surgery is not very beneficial. Some researchers have been prompted by this to consider whether drains should be inserted during thyroid surgery in which several research papers and meta-analyses have also failed to demonstrate the benefit of drainage in thyroid surgery. Blood clots in the drains could cause severe post-operative bleeding, preventing the surgeon from being notified. Difficult thyroidectomy cases might be predicted by factors linked to the patient, the thyroid, or the surgeon.

When thyroidectomies are performed under ideal conditions-that is, in a setting where good anatomical and physiological expertise is matched with meticulous surgical skills-complications are rare. The ability of the surgeon to do a thyroid surgery without difficulties is crucial. It is not possible to see routine drain use as a substitute for these components.

Percutaneous drains are frequently used in head and neck surgery cases. However, although effective at preventing post-operative haematoma formation, their use can also be associated with significant complications, including infection, fistulae, pain, psychosocial implications and most notably, prolongation of hospital stay.

Accordingly, some researchers that reject the use of intraoperative drains, there isn't a very high rate of wound hemorrhages following thyroid surgery. Additionally, other research indicates that there is no difference in the two groups' incidence of post-operative problems with and without drainage.

Nearly all surgeons utilize a closed vacuum drain after the intervention to avoid the deadliest complication, a smothering haemorrhage, which several studies suggest may not be essential

Study Overview

• Status: Recruiting
• Conditions: Benign Thyroid Diseases
• Intervention / Treatment: Procedure: thyroidectomy with drain; Procedure: thyroidectomy without drain

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mahmoud A Mahrez, Resident; Phone Number: +201094792499; Email: mahmoudabdelgaber@med.sohag.edu.eg
• Study Contact Backup: Name: Mohammed M Ali, Professor

Study Locations

• Egypt
  • Sohag, Egypt
    • Recruiting
    • Sohag University hospitals
    • Contact: Magdy M Amin, professor

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18-60 years.
• Both sexes.
• Unilateral \ bilateral thyroid benign nodules, with preoperative fine-needle aspiration biopsy.

Exclusion Criteria:

• Surgical contraindications such as coagulation dysfunction.
• Retrosternal goiter.
• A history of cervical surgery.
• Sever Co-morbid diseases (uncontrolled diabetes, sever cardiopulmonary disease).
• Malignancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Drain used in the thyroid surgery	Procedure: thyroidectomy with drain; hyroidectomy with subcutaneous suction drain
Active Comparator: No Drain used in the thyroid surgery	Procedure: thyroidectomy without drain; thyroidectomy without subcutaneous suction drain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications	This study aims to compare the effectiveness of Drainless Versus Drainage after thyroidectomy operations regarding post-operative short-term surgical site complications as pain, infections, seroma, haematoma and gaping in patients with benign thyroid diseases.	6 months

Collaborators and Investigators

• Sponsor: Sohag University

Publications and helpful links

General Publications

• Prichard RS, Murphy R, Lowry A, McLaughlin R, Malone C, Kerin MJ. The routine use of post-operative drains in thyroid surgery: an outdated concept. Ir Med J. 2010 Jan;103(1):26-7.
• Scerrino G, Paladino NC, Di Paola V, Morfino G, Amodio E, Gulotta G, Bonventre S. The use of haemostatic agents in thyroid surgery: efficacy and further advantages. Collagen-Fibrinogen-Thrombin Patch (CFTP) versus Cellulose Gauze. Ann Ital Chir. 2013 Sep-Oct;84(5):545-50.
• Sakorafas GH. Historical evolution of thyroid surgery: from the ancient times to the dawn of the 21st century. World J Surg. 2010 Aug;34(8):1793-804. doi: 10.1007/s00268-010-0580-7.
• Colak T, Akca T, Turkmenoglu O, Canbaz H, Ustunsoy B, Kanik A, Aydin S. Drainage after total thyroidectomy or lobectomy for benign thyroidal disorders. J Zhejiang Univ Sci B. 2008 Apr;9(4):319-23. doi: 10.1631/jzus.B0720257.
• Morrissey AT, Chau J, Yunker WK, Mechor B, Seikaly H, Harris JR. Comparison of drain versus no drain thyroidectomy: randomized prospective clinical trial. J Otolaryngol Head Neck Surg. 2008 Feb;37(1):43-7.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 7, 2024
• First Posted (Actual): May 13, 2024

Study Record Updates

• Last Update Posted (Actual): May 13, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Thyroid Diseases
• Other Study ID Numbers: Soh-Med-24-04-04MS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No