Thyroid DiseasesNCT07915960
Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy
A study testing ERAS protocol and Non ERAS local regimen in people with Thyroid Diseases and Ambulation Time, run by Allied Hospital Faisalabad at 1 site in Pakistan.
Trial summary
Patients undergoing thyroidectomy in hospital setup will be compared by applying ERAS protocol to one group and non ERAS local regimen to other group. Then comparison will be made in terms of length of hospital stay in days and time for ambulation in hours. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Thyroid Diseases, Ambulation Time, Hospital Stay
- What is being tested?
- ERAS protocol and Non ERAS local regimen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 14 May 2026to 19 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients aged 18-60 years.
- Patients scheduled for elective subtotal, near-total, or total thyroidectomy.
- Patients with ASA physical status I-III.
- Patients with acceptable preoperative haematological, hepatic, and renal function and thyroid function adequately controlled for elective surgery.
- Patients willing to complete the planned four-week follow-up.
- Patients providing voluntary written informed consent for participation in the study.
Who cannot join
- Patients undergoing thyroid lobectomy with or without isthmusectomy.
- Patients undergoing emergency thyroid surgery.
- Patients with ASA physical status greater than III.
- Pregnant patients.
- Patients with type I or type II diabetes mellitus.
- Patients unwilling to participate in the study or withdrawing consent before random allocation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site, 1 recruiting
- Recruiting
Allied Hospital Faisalabad
Faisalabad, Punjab Province
Tehreem H Doctor, MBBS, +923041696479, t.hannan95@gmail.com
About this study
Official title: Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy"
Patients undergoing thyroidectomy in hospital setup will be compared by applying ERAS protocol to one group and non ERAS local regimen to other group. Then comparison will be made in terms of length of hospital stay in days and time for ambulation in hours. Results will be compared showing which protocol is better and cost effective.
Read the detailed description
Following approval from the Ethical Review Committee (ERC) of Faisalabad Medical University, 96 eligible patients will be enrolled consecutively from the Department of General Surgery, Allied Hospital, Faisalabad. The purpose and procedures of the study will be explained to each eligible patient, and written informed consent will be obtained before enrolment.
Baseline demographic and clinical information, including age, sex, weight, duration of symptoms, comorbidities, ASA physical status, indication for surgery and planned extent of thyroidectomy, will be recorded. A detailed medical and surgical history and physical examination will be performed. Routine preoperative investigations, including haematological, biochemical and thyroid function tests, along with relevant radiological investigations, will be carried out. All patients will undergo preoperative anaesthetic assessment.
Following enrolment, participants will be randomly allocated in a 1:1 ratio to either Group A (ERAS protocol) or Group B (non-ERAS local perioperative regimen). Randomization will be performed using a computer-generated random allocation sequence comprising 48 assignments for each group. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes, which will be opened only after participant enrolment.
Group A will receive a structured Enhanced Recovery After Surgery (ERAS) protocol incorporating preoperative carbohydrate loading, pre-emptive analgesia, optimized anaesthetic and fluid management, local anaesthetic infiltration, avoidance of routine surgical drains, multimodal postoperative analgesia, antiemetic prophylaxis, early oral intake and early mobilization. Postoperative management will also include protocolized monitoring of neck swelling and voice changes, early calcium and parathyroid hormone assessment, and calcium and vitamin D supplementation when indicated.
Group B will receive the conventional non-ERAS local perioperative regimen, including preoperative fasting, standard anaesthetic management, conventional intraoperative fluid administration, routine surgical drain placement, conventional postoperative analgesia, reactive antiemetic treatment, delayed oral intake and mobilization, and routine postoperative monitoring and calcium assessment.
All thyroidectomy procedures will be performed or directly supervised by a surgeon at Senior Registrar level or above, using the standard departmental surgical technique. Following surgery and stabilization in the postoperative recovery area, participants will be transferred to the surgical ward and managed according to their allocated perioperative regimen.
The primary investigator will assess and record the study outcomes in both groups. The exact dates and times of completion of surgery, first postoperative ambulation and hospital discharge will be documented. Time to first ambulation will be calculated in hours from completion of surgery until the participant first gets out of bed and walks, either independently or with assistance. Length of hospital stay will be calculated from completion of surgery until actual hospital discharge and expressed in days.
Routine postoperative clinical assessments, including wound examination and monitoring for surgical and medical complications, will be performed in both groups. The same clinical discharge criteria will be applied to participants in both groups to minimize bias in the assessment of hospital stay. Participants will be discharged once they fulfil the clinical discharge criteria and will receive routine postoperative instructions and follow-up advice.
Postoperative follow-up will continue for four weeks after surgery. All collected information, including demographic characteristics, clinical findings, treatment allocation and postoperative outcomes, will be recorded and analysed using IBM SPSS Statistics version 25.0.
- Conditions
- Thyroid Diseases, Ambulation Time, Hospital Stay
- Being tested
- ERAS protocol, Non ERAS local regimen
- Keywords
- Enhanced recovery after surgery, Post operative outcomes
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolOther
four-phase Enhanced Recovery After Surgery (ERAS) pathway for elective thyroidectomy designed to optimize perioperative care and accelerate recovery: Preoperative: Focuses on patient education, optimization of comorbidities (including confirming euthyroid status), standard workup, and minimized fasting with clear liquids permitted up to 2 hours before anesthesia.
Intraoperative: Utilizes standardized general anesthesia, intraoperative warming, targeted fluid management, and risk-based antiemetic prophylaxis. It emphasizes multimodal, opioid-sparing analgesia while avoiding routine urinary catheters and reserving surgical drain placement for specific surgeon discretion.
Immediate Postoperative: Prioritizes close recovery room monitoring (airway, bleeding, pain, nausea), early oral intake as tolerated, non-opioid-focused pain management, and rapid mobilization within 6 hours post-op.
Postoperative \& Discharge: Involves routine monitoring for thyroidectomy-specific complications \&followup
Non ERAS local regimenOther
This non-ERAS/conventional care pathway for elective thyroidectomy follows Preoperative Phase: Involves standard patient counseling, baseline clinical and anesthetic assessments, euthyroid verification, and conventional fasting protocols without structured ERAS nutrition or clear-liquid loading.
Intraoperative Phase: Uses routine general anesthesia, standard fluid management, and traditional intraoperative analgesia and antiemetic administration as clinically indicated, rather than through a structured multimodal, opioid-sparing ERAS protocol. Catheter and surgical drain placement are left to surgeon discretion.
Immediate Postoperative Phase: Focuses on standard recovery room monitoring for airway and bleeding complications, PRN (as-needed) administration of analgesics and antiemetics, and initiation of oral intake and ambulation based on standard care and patient readiness.
Postoperative \& Discharge Phase: Includes routine monitoring of complications and follow up
| Study group | Role | What they receive |
|---|---|---|
| ERAS protocol group | Experimental | Patients undergoing thyroidectomy managed with the Enhanced Recovery After Surgery (ERAS) perioperative care protocol. Receives: Other: ERAS protocol |
| Non- ERAS local regimen | Active comparator | Patients undergoing thyroidectomy managed with standard local perioperative care regimens without ERAS implementation. Receives: Other: Non ERAS local regimen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulation time
Ambulation time in hours will be compared after applying ERAS protocol and non ERAS local regimen
Measured: 6 months
Length of hospital stay
Length of hospital stay will be measured in days after applying ERAS protocol and non ERAS local regimen
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 posted4 Nov 2026
- Study start14 May 2026
- Primary completion14 Nov 2026 (estimated)
- Study completion19 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Thyroid DiseasesStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-arm, parallel-group randomized controlled trial.
- Masking
- None (open label)
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Allied Hospital Faisalabad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tehreem Hannan, Allied Hospital Faisalabad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07915960
- Sponsor's protocol ID
- 08-2026
- Status last verified
- Oct 2026
- First submitted
- 30 Sep 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy"
- ClinicalTrials.gov ID
- NCT07915960
- Acronym / sponsor ID
- 08-2026
- Conditions
- Thyroid Diseases, Ambulation Time, Hospital Stay
- Keywords
- Enhanced recovery after surgery, Post operative outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Allied Hospital FaisalabadUniversity, hospital or other
- Study start
- 14 May 2026 (actual)
- Primary completion
- 14 Nov 2026 (estimated)
- Study completion
- 19 Nov 2026 (estimated)
- First posted
- 4 Nov 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.
Patients undergoing thyroidectomy in hospital setup will be compared by applying ERAS protocol to one group and non ERAS local regimen to other group. Then comparison will be made in terms of length of hospital stay in days and time for ambulation in hours. Results will be compared showing which protocol is better and cost effective.
Detailed description
Following approval from the Ethical Review Committee (ERC) of Faisalabad Medical University, 96 eligible patients will be enrolled consecutively from the Department of General Surgery, Allied Hospital, Faisalabad. The purpose and procedures of the study will be explained to each eligible patient, and written informed consent will be obtained before enrolment.
Baseline demographic and clinical information, including age, sex, weight, duration of symptoms, comorbidities, ASA physical status, indication for surgery and planned extent of thyroidectomy, will be recorded. A detailed medical and surgical history and physical examination will be performed. Routine preoperative investigations, including haematological, biochemical and thyroid function tests, along with relevant radiological investigations, will be carried out. All patients will undergo preoperative anaesthetic assessment.
Following enrolment, participants will be randomly allocated in a 1:1 ratio to either Group A (ERAS protocol) or Group B (non-ERAS local perioperative regimen). Randomization will be performed using a computer-generated random allocation sequence comprising 48 assignments for each group. Allocation will be concealed using sequentially numbered, opaque, sealed envelopes, which will be opened only after participant enrolment.
Group A will receive a structured Enhanced Recovery After Surgery (ERAS) protocol incorporating preoperative carbohydrate loading, pre-emptive analgesia, optimized anaesthetic and fluid management, local anaesthetic infiltration, avoidance of routine surgical drains, multimodal postoperative analgesia, antiemetic prophylaxis, early oral intake and early mobilization. Postoperative management will also include protocolized monitoring of neck swelling and voice changes, early calcium and parathyroid hormone assessment, and calcium and vitamin D supplementation when indicated.
Group B will receive the conventional non-ERAS local perioperative regimen, including preoperative fasting, standard anaesthetic management, conventional intraoperative fluid administration, routine surgical drain placement, conventional postoperative analgesia, reactive antiemetic treatment, delayed oral intake and mobilization, and routine postoperative monitoring and calcium assessment.
All thyroidectomy procedures will be performed or directly supervised by a surgeon at Senior Registrar level or above, using the standard departmental surgical technique. Following surgery and stabilization in the postoperative recovery area, participants will be transferred to the surgical ward and managed according to their allocated perioperative regimen.
The primary investigator will assess and record the study outcomes in both groups. The exact dates and times of completion of surgery, first postoperative ambulation and hospital discharge will be documented. Time to first ambulation will be calculated in hours from completion of surgery until the participant first gets out of bed and walks, either independently or with assistance. Length of hospital stay will be calculated from completion of surgery until actual hospital discharge and expressed in days.
Routine postoperative clinical assessments, including wound examination and monitoring for surgical and medical complications, will be performed in both groups. The same clinical discharge criteria will be applied to participants in both groups to minimize bias in the assessment of hospital stay. Participants will be discharged once they fulfil the clinical discharge criteria and will receive routine postoperative instructions and follow-up advice.
Postoperative follow-up will continue for four weeks after surgery. All collected information, including demographic characteristics, clinical findings, treatment allocation and postoperative outcomes, will be recorded and analysed using IBM SPSS Statistics version 25.0.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-arm, parallel-group randomized controlled trial.
| Arm | Type | Receives |
|---|---|---|
| ERAS protocol group | Experimental | Other: ERAS protocolPatients undergoing thyroidectomy managed with the Enhanced Recovery After Surgery (ERAS) perioperative care protocol. |
| Non- ERAS local regimen | Active comparator | Other: Non ERAS local regimenPatients undergoing thyroidectomy managed with standard local perioperative care regimens without ERAS implementation. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18-60 years.
- Patients scheduled for elective subtotal, near-total, or total thyroidectomy.
- Patients with ASA physical status I-III.
- Patients with acceptable preoperative haematological, hepatic, and renal function and thyroid function adequately controlled for elective surgery.
- Patients willing to complete the planned four-week follow-up.
Key exclusion criteria (6 listed)
- Patients undergoing thyroid lobectomy with or without isthmusectomy.
- Patients undergoing emergency thyroid surgery.
- Patients with ASA physical status greater than III.
- Pregnant patients.
- Patients with type I or type II diabetes mellitus.
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 |
|---|---|---|
| ERAS protocolfour-phase Enhanced Recovery After Surgery (ERAS) pathway for elective thyroidectomy designed to optimize perioperative care and accelerate recovery: Preoperative: Focuses on patient education, optimization of comorbidities (including confirming euthyroid status), standard workup, and minimized fasting with clear liquids permitted up to 2 hours before anesthesia. Intraoperative: Utilizes standardized general anesthesia, intraoperative warming, targeted fluid management, and risk-based antiemetic prophylaxis. It emphasizes multimodal, opioid-sparing analgesia while avoiding routine urinary catheters and reserving surgical drain placement for specific surgeon discretion. Immediate Postoperative: Prioritizes close recovery room monitoring (airway, bleeding, pain, nausea), early oral intake as tolerated, non-opioid-focused pain management, and rapid mobilization within 6 hours post-op. Postoperative \& Discharge: Involves routine monitoring for thyroidectomy-specific complications \&followup | Other | ERAS protocol group |
| Non ERAS local regimenThis non-ERAS/conventional care pathway for elective thyroidectomy follows Preoperative Phase: Involves standard patient counseling, baseline clinical and anesthetic assessments, euthyroid verification, and conventional fasting protocols without structured ERAS nutrition or clear-liquid loading. Intraoperative Phase: Uses routine general anesthesia, standard fluid management, and traditional intraoperative analgesia and antiemetic administration as clinically indicated, rather than through a structured multimodal, opioid-sparing ERAS protocol. Catheter and surgical drain placement are left to surgeon discretion. Immediate Postoperative Phase: Focuses on standard recovery room monitoring for airway and bleeding complications, PRN (as-needed) administration of analgesics and antiemetics, and initiation of oral intake and ambulation based on standard care and patient readiness. Postoperative \& Discharge Phase: Includes routine monitoring of complications and follow up | Other | Non- ERAS local regimen |
Primary outcome
Ambulation time
Time frame: 6 months
Ambulation time in hours will be compared after applying ERAS protocol and non ERAS local regimen
Length of hospital stay
Time frame: 6 months
Length of hospital stay will be measured in days after applying ERAS protocol and non ERAS local regimen
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ERAS protocol and Non ERAS local regimen in people with Thyroid Diseases and Ambulation Time, run by Allied Hospital Faisalabad 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 6 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: looking for participants now, as of the sponsor's last update on 4 Nov 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tehreem H Doctor, MBBS (+923041696479, t.hannan95@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ambulation time (time frame: 6 months). The study lists 2 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 4 Nov 2026.