Thyroid CancerNCT07488858
Thyroidectomy: Microscopic Versus Conventional
A study testing Microscopic Thyroidectomy and Conventional Thyroidectomy in people with Thyroid Cancer and Thyroid Surgeries, run by Shahida Islam Medical Complex at 1 site in Pakistan.
Trial summary
Despite promising findings from international studies, the use of microscopic thyroidectomy remains limited in local surgical practice, where conventional thyroidectomy is traditionally followed. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Thyroid Cancer, Thyroid Surgeries
- What is being tested?
- Microscopic Thyroidectomy and Conventional Thyroidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 74 participants
- Where
- 1 sitePakistan
- Study dates
- 16 Dec 2025to 15 Mar 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both Male or female patients.
- Patients aged 18 to 65 years undergoing thyroidectomy for benign or malignant thyroid disease.
- Patients with multinodular goiter, Grave's disease, thyroid carcinoma indicated for surgery based on their workup.
- Candidates scheduled for unilateral lobectomy, subtotal thyroidectomy, or total thyroidectomy.
- Patients with preoperative normal vocal cord mobility confirmed by laryngoscopy.
- Hemodynamically stable patients without significant comorbidities affecting surgery or anesthesia based on ASA classification (Class I-III).
- Patients who provide informed consent to participate in the study.
Who cannot join
- Prior history of prior thyroid surgery.
- Patients with evidence of lateral lymph node metastasis or local invasion on preoperative imaging (ultrasonography or computed tomography).
- Patients with pre-existing hypocalcemia or parathyroid disorders.
- Patients with severe medical comorbidities, including uncontrolled diabetes (HbA1c > 8%), chronic kidney disease (eGFR < 30 mL/min/1.73m²), liver cirrhosis (Child-Pugh class B or C), or coagulopathy (INR > 1.5 or platelet count < 50,000/μL), will be excluded from the study.
- Pregnant or lactating women.
- Patients with invasive thyroid carcinoma, anaplastic thyroid carcinoma, or thyroid lymphoma requiring extensive radical surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Outcomes of Microscopic Versus Conventional Thyroidectomy
Despite promising findings from international studies, the use of microscopic thyroidectomy remains limited in local surgical practice, where conventional thyroidectomy is traditionally followed. There is a scarcity of local data evaluating the benefits of MT, and inconsistencies in reported outcomes highlight the need for further research. The lack of standardized protocols and limited surgeon experience with microscopic techniques contribute to hesitation in its adoption.
This study aims to address the research gap by providing comparative data on operative time, intraoperative blood loss, and postoperative complications in microscopic versus conventional thyroidectomy in our setting. The findings will aid in determining whether MT should be incorporated into routine surgical practice to improve patient outcomes and reduce postoperative complications.
Read the detailed description
Thyroid disorders requiring surgical intervention are common, with conditions such as multi nodular goiter, thyroid malignancies, and hyperthyroidism frequently necessitating thyroidectomy. The procedure, while effective, poses risks due to the intricate anatomy of the thyroid gland and its proximity to critical structures such as the recurrent laryngeal nerve (RLN), external branch of the superior laryngeal nerve (EBSLN), and parathyroid glands. Complications like RLN palsy, hypocalcemia, and hematoma can result in significant morbidity. Hypocalcemia occurs in 20%-30% of cases, while RLN injury is reported in 5%-11%, with bilateral RLN paralysis being a rare but life-threatening complication. Minimizing these risks requires precise surgical techniques, adequate anatomical knowledge, and surgeon expertise. Thyroid surgery has evolved significantly, incorporating various approaches to enhance safety and outcomes. Conventional thyroidectomy (CT) remains the standard procedure, providing direct visualization and effective gland excision. Endoscopic thyroidectomy, utilizing minimal access techniques, has improved cosmetic outcomes but often involves longer operative times. The use of robotic-assisted thyroidectomy has further advanced precision, though cost and availability remain limiting factors. Microscopic thyroidectomy (MT), which involves magnification techniques for enhanced visualization, has been introduced to minimize complications. Studies suggest MT offers superior preservation of RLN, EBSLN, and parathyroid glands, reducing transient nerve palsies and hypocalcemia rates compared to conventional approaches.
However, it is essential to assess its efficacy in routine clinical practice.
- Conditions
- Thyroid Cancer, Thyroid Surgeries
- Being tested
- Microscopic Thyroidectomy, Conventional Thyroidectomy
- Keywords
- thyroidectomy, microscopic, laryngeal nerve palsy
- Medical subject headings
- Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microscopic ThyroidectomyProcedure or surgery
The procedure was done under general anesthesia but with an endotracheal intubation. Transverse cervical incision (45 cm) was done along a natural skin line. Magnification (Zeiss Sensera, 3-5x magnification) was employed in order to make the recurrent laryngeal nerve (RLN), external branch of the superior laryngeal nerve (EBSLN), and parathyroid glands easier to dissect. The ligatures were done at the superior pole of the thyroid gland and not at EBSLN. The RN was determined on the entry site to the larynx and kept in perfect condition. The parathyroid glands were distinguished, frozen or remedied in the event of the devascularization. The thyroid gland had been removed according to the intended operation (lobectomy, sub-total, or the total thyroidectomy). The wound was closed in layers and hemodynamics was restored
Conventional ThyroidectomyProcedure or surgery
A similar method was employed except that no microscopic magnification was employed. The standard visual techniques were used to identify RN and EBSLN and the process was accomplished according to the traditional approach. The traditional methods were used to identify and preserve parathyroid glands without any further magnification. The recovery room paid close attention to patients following surgery in case of any immediate complications such as bleeding or airway obstruction. Serum calcium levels were tested 24 hours after operation to determine whether they were hypocalcaemic and indirect laryngoscopy carried out prior to discharge to determine the functioning of the vocal cords
| Study group | Role | What they receive |
|---|---|---|
| Microscopic Thyroidectomy | Experimental | Not described Receives: Procedure: Microscopic Thyroidectomy |
| Conventional Thyroidectomy | Placebo comparator | Not described Receives: Procedure: Conventional Thyroidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean intraoperative blood loss
It will be defined as the mean total volume of blood lost during the surgical procedure, measured in milliliters (mL). Blood loss will be estimated using the difference between preoperative and postoperative suction canister volumes, accounting for irrigation fluids, and by weighing surgical sponges and gauze (1 g of blood = 1 mL).
Measured: 0 days
Percentage of Transient Recurrent Laryngeal Nerve (RLN) Palsy
postoperative unilateral or bilateral impairment of vocal cord mobility due to RLN dysfunction, confirmed by indirect laryngoscopy or videolaryngostroboscopy performed by an otolaryngologist. Diagnosis will be based on reduced or absent vocal cord movement compared to preoperative assessment. Patients exhibiting hoarseness, breathiness, or dysphonia with confirmed vocal cord dysfunction on laryngoscopic evaluation within one month postoperatively will be labeled as transient RLN palsy. Any patient showing full recovery of vocal cord mobility on follow-up laryngoscopy at one month will be classified as transient.
Measured: one month
Percentage of Permanent Recurrent Laryngeal Nerve (RLN) Palsy
persistent postoperative unilateral or bilateral vocal cord paralysis confirmed by indirect laryngoscopy or videolaryngostroboscopy at one month postoperatively by an otolaryngologist. Diagnosis will require complete absence of vocal cord movement on objective examination at one month, without any signs of recovery. Patients with persistent hoarseness, dysphonia, or aspiration symptoms accompanied by vocal cord immobility at one month will be definitively classified as having permanent RLN palsy.
Measured: one month
percentage of Transient Hypocalcemia
It will be labeled as transient hypocalcemia if the patient experiences symptoms such as perioral numbness, carpopedal spasms, or tetany within one month of surgery, with laboratory confirmation of serum calcium < 8.0 mg/dL. Diagnosis will be based on serial calcium measurements, and resolution within one month without continued supplementation will confirm its transient nature.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start16 Dec 2025
- Primary completion15 Mar 2026
- Study completion15 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid CancerStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shahida Islam Medical Complex
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Mudassar Saeed Pansota, Shahida Islam Medical Complex
- Investigators
- mudassar saeed pansota, Principal investigator, Assistant Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07488858
- Sponsor's protocol ID
- Sheikh Zayed Hospital Lahore 1
- Status last verified
- Mar 2026
- First submitted
- 15 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Microscopic Versus Conventional Thyroidectomy
- ClinicalTrials.gov ID
- NCT07488858
- Acronym / sponsor ID
- Sheikh Zayed Hospital Lahore 1
- Conditions
- Thyroid Cancer, Thyroid Surgeries
- Keywords
- thyroidectomy, microscopic, laryngeal nerve palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Shahida Islam Medical ComplexUniversity, hospital or other
- Study start
- 16 Dec 2025 (actual)
- Primary completion
- 15 Mar 2026 (actual)
- Study completion
- 15 Mar 2026 (actual)
- First posted
- 23 Mar 2026 (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.
Despite promising findings from international studies, the use of microscopic thyroidectomy remains limited in local surgical practice, where conventional thyroidectomy is traditionally followed. There is a scarcity of local data evaluating the benefits of MT, and inconsistencies in reported outcomes highlight the need for further research. The lack of standardized protocols and limited surgeon experience with microscopic techniques contribute to hesitation in its adoption.
This study aims to address the research gap by providing comparative data on operative time, intraoperative blood loss, and postoperative complications in microscopic versus conventional thyroidectomy in our setting. The findings will aid in determining whether MT should be incorporated into routine surgical practice to improve patient outcomes and reduce postoperative complications.
Detailed description
Thyroid disorders requiring surgical intervention are common, with conditions such as multi nodular goiter, thyroid malignancies, and hyperthyroidism frequently necessitating thyroidectomy. The procedure, while effective, poses risks due to the intricate anatomy of the thyroid gland and its proximity to critical structures such as the recurrent laryngeal nerve (RLN), external branch of the superior laryngeal nerve (EBSLN), and parathyroid glands. Complications like RLN palsy, hypocalcemia, and hematoma can result in significant morbidity. Hypocalcemia occurs in 20%-30% of cases, while RLN injury is reported in 5%-11%, with bilateral RLN paralysis being a rare but life-threatening complication. Minimizing these risks requires precise surgical techniques, adequate anatomical knowledge, and surgeon expertise. Thyroid surgery has evolved significantly, incorporating various approaches to enhance safety and outcomes. Conventional thyroidectomy (CT) remains the standard procedure, providing direct visualization and effective gland excision. Endoscopic thyroidectomy, utilizing minimal access techniques, has improved cosmetic outcomes but often involves longer operative times. The use of robotic-assisted thyroidectomy has further advanced precision, though cost and availability remain limiting factors. Microscopic thyroidectomy (MT), which involves magnification techniques for enhanced visualization, has been introduced to minimize complications. Studies suggest MT offers superior preservation of RLN, EBSLN, and parathyroid glands, reducing transient nerve palsies and hypocalcemia rates compared to conventional approaches.
However, it is essential to assess its efficacy in routine clinical practice.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microscopic Thyroidectomy | Experimental | Procedure: Microscopic Thyroidectomy |
| Conventional Thyroidectomy | Placebo comparator | Procedure: Conventional Thyroidectomy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Both Male or female patients.
- Patients aged 18 to 65 years undergoing thyroidectomy for benign or malignant thyroid disease.
- Patients with multinodular goiter, Grave's disease, thyroid carcinoma indicated for surgery based on their workup.
- Candidates scheduled for unilateral lobectomy, subtotal thyroidectomy, or total thyroidectomy.
- Patients with preoperative normal vocal cord mobility confirmed by laryngoscopy.
Key exclusion criteria (6 listed)
- Prior history of prior thyroid surgery.
- Patients with evidence of lateral lymph node metastasis or local invasion on preoperative imaging (ultrasonography or computed tomography).
- Patients with pre-existing hypocalcemia or parathyroid disorders.
- Patients with severe medical comorbidities, including uncontrolled diabetes (HbA1c > 8%), chronic kidney disease (eGFR < 30 mL/min/1.73m²), liver cirrhosis (Child-Pugh class B or C), or coagulopathy (INR > 1.5 or platelet count < 50,000/μL), will be excluded from the study.
- Pregnant or lactating women.
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 |
|---|---|---|
| Microscopic ThyroidectomyThe procedure was done under general anesthesia but with an endotracheal intubation. Transverse cervical incision (45 cm) was done along a natural skin line. Magnification (Zeiss Sensera, 3-5x magnification) was employed in order to make the recurrent laryngeal nerve (RLN), external branch of the superior laryngeal nerve (EBSLN), and parathyroid glands easier to dissect. The ligatures were done at the superior pole of the thyroid gland and not at EBSLN. The RN was determined on the entry site to the larynx and kept in perfect condition. The parathyroid glands were distinguished, frozen or remedied in the event of the devascularization. The thyroid gland had been removed according to the intended operation (lobectomy, sub-total, or the total thyroidectomy). The wound was closed in layers and hemodynamics was restored | Procedure or surgery | Microscopic Thyroidectomy |
| Conventional ThyroidectomyA similar method was employed except that no microscopic magnification was employed. The standard visual techniques were used to identify RN and EBSLN and the process was accomplished according to the traditional approach. The traditional methods were used to identify and preserve parathyroid glands without any further magnification. The recovery room paid close attention to patients following surgery in case of any immediate complications such as bleeding or airway obstruction. Serum calcium levels were tested 24 hours after operation to determine whether they were hypocalcaemic and indirect laryngoscopy carried out prior to discharge to determine the functioning of the vocal cords | Procedure or surgery | Conventional Thyroidectomy |
Primary outcome
Mean intraoperative blood loss
Time frame: 0 days
It will be defined as the mean total volume of blood lost during the surgical procedure, measured in milliliters (mL). Blood loss will be estimated using the difference between preoperative and postoperative suction canister volumes, accounting for irrigation fluids, and by weighing surgical sponges and gauze (1 g of blood = 1 mL).
Percentage of Transient Recurrent Laryngeal Nerve (RLN) Palsy
Time frame: one month
postoperative unilateral or bilateral impairment of vocal cord mobility due to RLN dysfunction, confirmed by indirect laryngoscopy or videolaryngostroboscopy performed by an otolaryngologist. Diagnosis will be based on reduced or absent vocal cord movement compared to preoperative assessment. Patients exhibiting hoarseness, breathiness, or dysphonia with confirmed vocal cord dysfunction on laryngoscopic evaluation within one month postoperatively will be labeled as transient RLN palsy. Any patient showing full recovery of vocal cord mobility on follow-up laryngoscopy at one month will be classified as transient.
Percentage of Permanent Recurrent Laryngeal Nerve (RLN) Palsy
Time frame: one month
persistent postoperative unilateral or bilateral vocal cord paralysis confirmed by indirect laryngoscopy or videolaryngostroboscopy at one month postoperatively by an otolaryngologist. Diagnosis will require complete absence of vocal cord movement on objective examination at one month, without any signs of recovery. Patients with persistent hoarseness, dysphonia, or aspiration symptoms accompanied by vocal cord immobility at one month will be definitively classified as having permanent RLN palsy.
percentage of Transient Hypocalcemia
Time frame: one month
It will be labeled as transient hypocalcemia if the patient experiences symptoms such as perioral numbness, carpopedal spasms, or tetany within one month of surgery, with laboratory confirmation of serum calcium < 8.0 mg/dL. Diagnosis will be based on serial calcium measurements, and resolution within one month without continued supplementation will confirm its transient nature.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Individual participant dataSharing planned: No
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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.
mudassar saeed pansota principal investigator
Assistant Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microscopic Thyroidectomy and Conventional Thyroidectomy in people with Thyroid Cancer and Thyroid Surgeries, run by Shahida Islam Medical Complex at 1 site in Pakistan.
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 7 inclusion and 6 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: finished, as of the sponsor's last update on 23 Mar 2026. 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 Pakistan. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean intraoperative blood loss (time frame: 0 days). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.