Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 1:29 AM
Study NCT ID:
NCT07488858
Status:
COMPLETED
Last Update Posted:
2026-03-23
First Post:
2026-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thyroidectomy: Microscopic Versus Conventional
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 74}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-12-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2026-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-18', 'studyFirstSubmitDate': '2026-03-15', 'studyFirstSubmitQcDate': '2026-03-18', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean intraoperative blood loss', 'timeFrame': '0 days', 'description': '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).'}, {'measure': 'Percentage of Transient Recurrent Laryngeal Nerve (RLN) Palsy', 'timeFrame': 'one month', 'description': '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.'}, {'measure': 'Percentage of Permanent Recurrent Laryngeal Nerve (RLN) Palsy', 'timeFrame': 'one month', 'description': '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.'}, {'measure': 'percentage of Transient Hypocalcemia', 'timeFrame': 'one month', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['thyroidectomy', 'microscopic', 'laryngeal nerve palsy'], 'conditions': ['Thyroid Cancer', 'Thyroid Surgeries']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.', 'detailedDescription': '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.\n\nHowever, it is essential to assess its efficacy in routine clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Both Male or female patients.\n* Patients aged 18 to 65 years undergoing thyroidectomy for benign or malignant thyroid disease.\n* Patients with multinodular goiter, Grave's disease, thyroid carcinoma indicated for surgery based on their workup.\n* Candidates scheduled for unilateral lobectomy, subtotal thyroidectomy, or total thyroidectomy.\n* Patients with preoperative normal vocal cord mobility confirmed by laryngoscopy.\n\nHemodynamically stable patients without significant comorbidities affecting surgery or anesthesia based on ASA classification (Class I-III).\n\n• Patients who provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n• Prior history of prior thyroid surgery.\n\n* Patients with evidence of lateral lymph node metastasis or local invasion on preoperative imaging (ultrasonography or computed tomography).\n* Patients with pre-existing hypocalcemia or parathyroid disorders.\n* 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.\n* Pregnant or lactating women.\n* Patients with invasive thyroid carcinoma, anaplastic thyroid carcinoma, or thyroid lymphoma requiring extensive radical surgery."}, 'identificationModule': {'nctId': 'NCT07488858', 'briefTitle': 'Thyroidectomy: Microscopic Versus Conventional', 'organization': {'class': 'OTHER', 'fullName': 'Shahida Islam Medical Complex'}, 'officialTitle': 'Comparison of Outcomes of Microscopic Versus Conventional Thyroidectomy', 'orgStudyIdInfo': {'id': 'Sheikh Zayed Hospital Lahore 1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Microscopic Thyroidectomy', 'interventionNames': ['Procedure: Microscopic Thyroidectomy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Conventional Thyroidectomy', 'interventionNames': ['Procedure: Conventional Thyroidectomy']}], 'interventions': [{'name': 'Microscopic Thyroidectomy', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['Microscopic Thyroidectomy']}, {'name': 'Conventional Thyroidectomy', 'type': 'PROCEDURE', 'description': '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', 'armGroupLabels': ['Conventional Thyroidectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60000', 'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Shaikh Zayed Hospital, Lahore', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}], 'overallOfficials': [{'name': 'mudassar saeed pansota', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistant Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahida Islam Medical Complex', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Dr Mudassar Saeed Pansota', 'investigatorAffiliation': 'Shahida Islam Medical Complex'}}}}