Randomized Controlled Trial Comparing Drains Usage Vs Without Drains After Thyroid Surgery

January 3, 2025 updated by: Helmy Khaled Helmy, Assiut University

Drain Vs No Drain After Thyroid Surgeries: a Prospective Randomized Clinical Trial.

The aim of this study is to compare patients who used drain to patients who did not use drain post-thyroidectomy regarding the short-term outcomes .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) Male or female patients undergoing thyroidectomy (2) Patients with ages: from 18 to 60 years old. (3) Patients with normal thyroid function tests (4) Patients who are fit for general-anesthesia.

Exclusion Criteria:

  • (1) Patients with bleeding diathesis and those on anticoagulants. (2) Patients with thyrotoxicosis (uncontrolled) (3) Patients those requiring neck L.N dissection. (4) Patients with previous neck surgeries. (5) Patients with severe comorbid conditions with high risk for general anesthesia.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group drain (A)
Drain placement post thyroid surgery
Device: Suction Drain placement (Example: Q-vac)
After thyroid surgery we pust drain at bed of surgery to monitor post operative bleeding.
No Intervention: Group no drain (B)
No drain placement post thyroid surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of hematoma post-operative .
Time Frame: 24 hours
Rate of post operative hematoma formation and effect of drain in preventing it
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rate of infection
Time Frame: 7 days
Compare Rate of surgical site infection between two groups
7 days
Rate of re intervention
Time Frame: 7 days
7 days
Post-operative pain by visual analogue scale
Time Frame: 3 days
3 days
Post-operative hospital stay in days
Time Frame: 7 days
Length of hospital stay: described as the length of a single hospitalization, which is determined by subtracting the day of admission from the day of discharge. Data are collected from patients underwent thyroid surgery using a pretested, structured interviewer-administered questionnaire, medical record review,
7 days
Patient satisfaction by likert scale
Time Frame: 7 days
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Mostafa Abdel ghafour, Affiliated

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

January 1, 2027

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 3, 2025

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Drains Post thyroidectomy

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

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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