Benign Thyroid DiseasesNCT06410937
Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications
A study testing thyroidectomy without drain and thyroidectomy with drain in people with Benign Thyroid Diseases, run by Sohag University at 1 site in Egypt.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Benign Thyroid Diseases
- What is being tested?
- thyroidectomy without drain and thyroidectomy with drain
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- May 2024to Sep 2024
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years.
- Both sexes.
- Unilateral \ bilateral thyroid benign nodules, with preoperative fine-needle aspiration biopsy.
Who cannot join
- Surgical contraindications such as coagulation dysfunction.
- Retrosternal goiter.
- A history of cervical surgery.
- Sever Co-morbid diseases (uncontrolled diabetes, sever cardiopulmonary disease).
- Malignancy.
Trial locations and contacts
1 site in 1 country.
Mohammed M Ali, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor
About this study
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.
Read more
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
- Conditions
- Benign Thyroid Diseases
- Being tested
- thyroidectomy without drain, thyroidectomy with drain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thyroidectomy without drainProcedure or surgery
thyroidectomy without subcutaneous suction drain
thyroidectomy with drainProcedure or surgery
hyroidectomy with subcutaneous suction drain
| Study group | Role | What they receive |
|---|---|---|
| Drain used in the thyroid surgery | Active comparator | Not described Receives: Procedure: thyroidectomy with drain |
| No Drain used in the thyroid surgery | Active comparator | Not described Receives: Procedure: thyroidectomy without drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
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 posted13 May 2024
- Study startMay 2024 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Benign Thyroid DiseasesStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdelgaber Mehrez, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06410937
- Sponsor's protocol ID
- Soh-Med-24-04-04MS
- Status last verified
- May 2024
- First submitted
- 2 May 2024
- Last updated
- 13 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 20222393Scerrino 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.
PubMed 23502460Sakorafas 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.
PubMed 20401481Colak 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.
PubMed 18381807Morrissey 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.
PubMed 18479627
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications
- ClinicalTrials.gov ID
- NCT06410937
- Acronym / sponsor ID
- Soh-Med-24-04-04MS
- Conditions
- Benign Thyroid Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 13 May 2024 (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.
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 design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drain used in the thyroid surgery | Active comparator | Procedure: thyroidectomy with drain |
| No Drain used in the thyroid surgery | Active comparator | Procedure: thyroidectomy without drain |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-60 years.
- Both sexes.
- Unilateral \ bilateral thyroid benign nodules, with preoperative fine-needle aspiration biopsy.
Key exclusion criteria (5 listed)
- Surgical contraindications such as coagulation dysfunction.
- Retrosternal goiter.
- A history of cervical surgery.
- Sever Co-morbid diseases (uncontrolled diabetes, sever cardiopulmonary disease).
- Malignancy.
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 |
|---|---|---|
| thyroidectomy without drainthyroidectomy without subcutaneous suction drain | Procedure or surgery | No Drain used in the thyroid surgery |
| thyroidectomy with drainhyroidectomy with subcutaneous suction drain | Procedure or surgery | Drain used in the thyroid surgery |
Primary outcome
Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications
Time frame: 6 months
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Background: PubMed 20222393Prichard 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.
- Background: PubMed 23502460Scerrino 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.
- Background: PubMed 20401481Sakorafas 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.
- Background: PubMed 18381807Colak 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.
- Background: PubMed 18479627Morrissey 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.
- Individual participant dataSharing planned: Undecided
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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.
Mohammed M Ali, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thyroidectomy without drain and thyroidectomy with drain in people with Benign Thyroid Diseases, run by Sohag University at 1 site in Egypt.
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 3 inclusion and 5 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 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 A Mahrez, Resident (+201094792499, mahmoudabdelgaber@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation Of Drainless Thyroidectomy For Benign Thyroid Diseases Regarding Surgical Site Complications (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 NCT06410937, which also lists 5 linked publications.
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 13 May 2024.