Sutureless Versus Conventional Thyroidectomy

• Sponsor: Mansoura University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03615456
• Collaborator: (none)
• Enrollment: 42
• Location: 1
• Arms: 2
• Actual Duration (Months): 15.3
• Patients Per Site Per Month: 2.7

Study Details

Study Description

Brief Summary

This study was prospective randomized double-blinded clinical trial on patients with thyroid disease who underwent thyroidectomy in the general surgery department, Mansoura university hospitals during the period of February 2017 to February 2018.Two techniques for vascular sealing were compared: conventional tying and harmonic scalpel

Condition or Disease	Intervention/Treatment	Phase
Goiter	Procedure: Conventional thyroidectomy; Procedure: Harmonic scalpel thyroidectomy	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 42 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Sutureless Thyroidectomy Versus Conventional Thyroidectomy: Prospective Randomized Clinical Trial
• Actual Study Start Date: Feb 1, 2017
• Actual Primary Completion Date: Feb 28, 2018
• Actual Study Completion Date: May 12, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Conventional thyroidectomy Thyroidectomy with ligation and division of thyroid vessels	Procedure: Conventional thyroidectomy; Thyroid vessels are ligated with sutures and divided
Active Comparator: Harmonic scalpel thyroidectomy Thyroidectomy with sealing of thyroid vessels using harmonic scalpel	Procedure: Harmonic scalpel thyroidectomy; Thyroid vessels are sealed using harmonic scalpel device

Outcome Measures

Primary Outcome Measures

1. Volume of postoperative drainage [At 24 hours after surgery]

   The volume of fluid drained in the suction drain placed in the neck in milliliters

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

Patients of both genders aging above 18 years presented with primary thyroid diseases requiring thyroidectomy including:

• Solitary thyroid nodule (STN)

• Multinodular goiter

• Controlled toxic goiter

• Inflammatory goiter (thyroiditis)

• Early-stage thyroid cancer.

Exclusion Criteria:

• Patients unfit for surgery

• patients unwilling to participate in the study

• Pregnant women

• Thyroid cancer with lymph node or distant metastasis.

• Patients with psychiatric disturbances.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mansoura university hospital	Mansourah	Dakahlia	Egypt	35516

Sponsors and Collaborators

• Mansoura University

Investigators

• Study Chair: Sabry Mahmoud, M.D., Mansoura University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sameh Emile, Assistant professor of surgery, Mansoura University
• ClinicalTrials.gov Identifier: NCT03615456
• Other Study ID Numbers: mansoura62
• First Posted: Aug 3, 2018
• Last Update Posted: Feb 5, 2019
• Last Verified: Feb 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Goiter

Study Results

No Results Posted as of Feb 5, 2019