ThyroidNCT05567432
Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure
A study testing thyroidectomy in people with Thyroid, run by Assiut University.
Trial summary
Thyroidectomy is one of the most surgeries done by surgeons. Postoperative bleeding is a main complication for this surgery.surgeons usually do homeostasis by traditional diathermy as it is cheep and available in all hospitals and centres. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Thyroid
- What is being tested?
- thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2023to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- • Patient with disburbed thyroid function and candidate for for thyroidectomy
Who cannot join
- Low preoperative calcium level and Patient with contraindication of uses of ligasure or diathermy.
Trial locations and contacts
No sites are listed yet.
About this study
Thyroidectomy is one of the most surgeries done by surgeons. Postoperative bleeding is a main complication for this surgery.surgeons usually do homeostasis by traditional diathermy as it is cheep and available in all hospitals and centres.
Atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.
Read the detailed description
Thyroid surgery is one of the most frequently performed surgical procedures worldwide . Nowadays, total thyroidectomy is the recommended procedure for thyroid disease . As total thyroidectomy is the procedure of choice, the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24% - which increases the morbidity rate and increases the length of hospitalization. Other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice, postoperative hemorrhage, dysphagia due to inflammation of the tissues surrounding the esophagus, seroma formation, Horner's syndrome due to injury to the cervical sympathetic chain, and poor healing of the wound with hypertrophy of the scar or wound infection .
Atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.
- Conditions
- Thyroid
- Being tested
- thyroidectomy
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroidectomyProcedure or surgery
use diathermy or ligasure for homeostatic during thyroidectomy
| Study group | Role | What they receive |
|---|---|---|
| Patients will do throidectomy using diathermy | Active comparator | In these patients the investigators will control bleeding and cut tissues and blood vessels using the diathermy . Receives: Procedure: thyroidectomy |
| Patients will do thyroidectomy using ligasure . | Active comparator | In these patients the investigators will control bleeding and cut tissues and blood vessels using the liagasure. Receives: Procedure: thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Finding the best methode to decrease intraoperative and postoperative bleeding during thyroidectomy
This study is aiming to make a comparison between the incidence of intraoperative and postoperative bleeding while using diathermy versus using ligasure in homeostasis during thyroidectomy.
- The investigators will do their best to answer this question... 1. ls rate of postoperative complications decrease while using the ligasure than using traditional diathermy ?
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start1 Jan 2023 (estimated)
- Primary completion30 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ThyroidStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- In about 20 participants , the investigators will control bleeding and cut tissues and blood vessels using the diathermy and in the other 20 , investigators will do homeostasis with ligasure.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Mohamed Aboelhassan Guishy, Assiut University
- Investigators
- Mohamed Korany, PHD, Study director, Assut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05567432
- Sponsor's protocol ID
- htdl
- Status last verified
- Oct 2022
- First submitted
- 17 Sep 2022
- Last updated
- 5 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Manouras A, Markogiannakis H, Koutras AS, Antonakis PT, Drimousis P, Lagoudianakis EE, Kekis P, Genetzakis M, Koutsoumanis K, Bramis I. Thyroid surgery: comparison between the electrothermal bipolar vessel sealing system, harmonic scalpel, and classic suture ligation. Am J Surg. 2008 Jan;195(1):48-52. doi: 10.1016/j.amjsurg.2007.01.037.
PubMed 18082542
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostasis in Thyroidectomy, Comparison Between Diathermy and Ligasure
- ClinicalTrials.gov ID
- NCT05567432
- Acronym / sponsor ID
- htdl
- Conditions
- Thyroid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Thyroidectomy is one of the most surgeries done by surgeons. Postoperative bleeding is a main complication for this surgery.surgeons usually do homeostasis by traditional diathermy as it is cheep and available in all hospitals and centres.
Atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.
Detailed description
Thyroid surgery is one of the most frequently performed surgical procedures worldwide . Nowadays, total thyroidectomy is the recommended procedure for thyroid disease . As total thyroidectomy is the procedure of choice, the most common complication resulting after this surgery is transient hypocalcemia - the incidence being 24% - which increases the morbidity rate and increases the length of hospitalization. Other complications of thyroidectomy include recurrent laryngeal nerve injury which leads to hoarseness of voice, postoperative hemorrhage, dysphagia due to inflammation of the tissues surrounding the esophagus, seroma formation, Horner's syndrome due to injury to the cervical sympathetic chain, and poor healing of the wound with hypertrophy of the scar or wound infection .
Atlternatinve surgery devices have become popular to conventional hemostasis in thyroid surgery. These devices reduce operative time and post-operative complication .Investigators thought to examine relative efficiency of two alternative energy devices compared to each other in preventing post-operative complication between diathermy and ligasure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- In about 20 participants , the investigators will control bleeding and cut tissues and blood vessels using the diathermy and in the other 20 , investigators will do homeostasis with ligasure.
| Arm | Type | Receives |
|---|---|---|
| Patients will do throidectomy using diathermy | Active comparator | Procedure: thyroidectomyIn these patients the investigators will control bleeding and cut tissues and blood vessels using the diathermy . |
| Patients will do thyroidectomy using ligasure . | Active comparator | Procedure: thyroidectomyIn these patients the investigators will control bleeding and cut tissues and blood vessels using the liagasure. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- • Patient with disburbed thyroid function and candidate for for thyroidectomy
Key exclusion criteria (1 listed)
- Low preoperative calcium level and Patient with contraindication of uses of ligasure or diathermy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| thyroidectomyuse diathermy or ligasure for homeostatic during thyroidectomy | Procedure or surgery | Patients will do throidectomy using diathermy, Patients will do thyroidectomy using ligasure . |
Primary outcome
Finding the best methode to decrease intraoperative and postoperative bleeding during thyroidectomy
Time frame: 6 months
This study is aiming to make a comparison between the incidence of intraoperative and postoperative bleeding while using diathermy versus using ligasure in homeostasis during thyroidectomy. * The investigators will do their best to answer this question... 1. ls rate of postoperative complications decrease while using the ligasure than using traditional diathermy ?
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2022.
- Background: PubMed 18082542Manouras A, Markogiannakis H, Koutras AS, Antonakis PT, Drimousis P, Lagoudianakis EE, Kekis P, Genetzakis M, Koutsoumanis K, Bramis I. Thyroid surgery: comparison between the electrothermal bipolar vessel sealing system, harmonic scalpel, and classic suture ligation. Am J Surg. 2008 Jan;195(1):48-52. doi: 10.1016/j.amjsurg.2007.01.037.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed Korany, PHD study director
Assut University
Questions about this trial
What is this clinical trial studying?
A study testing thyroidectomy in people with Thyroid, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mahmoud Aboelhassan, Master (00201024529525, mahmoudaboelhassen37@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Finding the best methode to decrease intraoperative and postoperative bleeding during thyroidectomy (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05567432, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2022.