NCT07488858

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
74

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2025

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 15, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 23, 2026

Completed
Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 15, 2026

Last Update Submit

March 18, 2026

Conditions

Keywords

thyroidectomymicroscopiclaryngeal nerve palsy

Outcome Measures

Primary Outcomes (4)

  • 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).

    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.

    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.

    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.

    one month

Study Arms (2)

Microscopic Thyroidectomy

EXPERIMENTAL
Procedure: Microscopic Thyroidectomy

Conventional Thyroidectomy

PLACEBO COMPARATOR
Procedure: Conventional Thyroidectomy

Interventions

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

Microscopic Thyroidectomy

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

Conventional Thyroidectomy

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaikh Zayed Hospital, Lahore

Lahore, Punjab Province, 60000, Pakistan

Location

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • mudassar saeed pansota

    Assistant Professor of Urology, Shahida Islam Teaching Hospital, Lodhran, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 15, 2026

First Posted

March 23, 2026

Study Start

December 16, 2025

Primary Completion

March 15, 2026

Study Completion

March 15, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations