Thyroid DiseasesNCT07575243
Thyroidectomy-specific Enhanced Recovery After Surgery (ERAS) Protocol
An observational study of Thyroid Diseases and Goiter, run by Assiut University at 1 site in Egypt.
Trial summary
Thyroidectomy is generally considered a low-to-moderate risk operation; however, postoperative pain, nausea/vomiting, and prolonged hospital stays remain common issues. Enhanced Recovery After Surgery (ERAS) pathways aim to optimize perioperative care and accelerate recovery. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Thyroid Diseases, Goiter, Thyroid Neoplasms
- What is being tested?
- Enhanced Recovery After Surgery protocol and Conventional perioperative care
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- How many people
- 143 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2024to 31 May 2025
- Phase
- Observational
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective thyroidectomy for benign or malignant disease at a tertiary cancer institute
Who may be able to join
- Patients aged 18-75 years
- ASA physical status I-III.
- Scheduled for elective thyroidectomy for benign or malignant disease.
Who cannot join
- Re-operative thyroid surgery
- Concomitant neck dissection
- Inability to comply with the ERAS pathway
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Surgical Oncology Department, South Egypt Cancer Institute, Assiut University
Asyut, Asyut Governorate, 71516
About this study
Official title: A Comprehensive Enhanced Recovery After Surgery (ERAS) Protocol for Thyroidectomy
Thyroidectomy is generally considered a low-to-moderate risk operation; however, postoperative pain, nausea/vomiting, and prolonged hospital stays remain common issues. Enhanced Recovery After Surgery (ERAS) pathways aim to optimize perioperative care and accelerate recovery. This study evaluates the effectiveness and safety of a standardized ERAS pathway in patients undergoing elective thyroidectomy. The prospective ERAS cohort is compared with a historical control group receiving conventional care to assess the impact on the length of hospital stay, postoperative pain, opioid consumption, and complication rates.
- Conditions
- Thyroid Diseases, Goiter, Thyroid Neoplasms
- Being tested
- Enhanced Recovery After Surgery protocol, Conventional perioperative care
- Keywords
- Enhanced recovery after surgery, ERAS, Multimodal perioperative care, Length of hospital stay, Thyroidectomy, Opioid-sparing multimodal analgesia
- Medical subject headings
- Thyroid Diseases, Goiter, Thyroid Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Recovery After Surgery protocolProcedure or surgery
Also called ERAS
This incorporates standardized preoperative counseling, reduced fasting, multimodal opioid-sparing analgesia, total intravenous anesthesia, selective drain use, early oral intake and mobilization, and PTH-guided calcium supplementation
Conventional perioperative careProcedure or surgery
This often involves prolonged preoperative fasting, opioid-based analgesia, and delayed mobilization
| Study group | Role | What they receive |
|---|---|---|
| ERAS group | A prospective cohort undergoing elective thyroidectomy under an ERAS protocol. Receives: Procedure: Enhanced Recovery After Surgery protocol | |
| Control group | A historical control cohort undergoing thyroidectomy under conventional care during the 12 months preceding ERAS implementation Receives: Procedure: Conventional perioperative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
Hours from surgery end to discharge
Measured: Up to 30 days post-surgery
Secondary outcomes (5)
Postoperative pain scores
Mean Numeric Rating Scale (NRS-11; 0 = no pain to 10 = worst imaginable pain) at rest in 24 hours. NRS scores are categorized as mild (1-3), moderate (4-6), or severe (7-10).
Measured: Assessed in the first 24 hours postoperatively
Total opioid consumption
Oral Morphine Milligram Equivalents (MME)
Measured: Within first 24 hours
Postoperative nausea and vomiting (PONV)
Incidence of PONV
Measured: Up to 24 hours postoperatively
Rate of postoperative hypocalcemia
Biochemical and symptomatic occurrences
Measured: First 30 days from the surgery
30-day unplanned readmission rate
Number of unplanned readmissions
Measured: Up to 30 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2026
- Study start1 May 2024
- Primary completion31 May 2025
- Study completion31 May 2025
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 Thyroid DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 143 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed I Omar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07575243
- Sponsor's protocol ID
- M.I.Omar-ERAS26
- Status last verified
- May 2026
- First submitted
- 2 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Althans AR, Holder-Murray J, Tessler RA. The Future of Enhanced Recovery After Surgery-Precision vs Protocol. JAMA Netw Open. 2024 Jun 3;7(6):e2418968. doi: 10.1001/jamanetworkopen.2024.18968. No abstract available.
PubMed 38888927Sauro KM, Smith C, Ibadin S, Thomas A, Ganshorn H, Bakunda L, Bajgain B, Bisch SP, Nelson G. Enhanced Recovery After Surgery Guidelines and Hospital Length of Stay, Readmission, Complications, and Mortality: A Meta-Analysis of Randomized Clinical Trials. JAMA Netw Open. 2024 Jun 3;7(6):e2417310. doi: 10.1001/jamanetworkopen.2024.17310.
PubMed 38888922Simpson JC, Bao X, Agarwala A. Pain Management in Enhanced Recovery after Surgery (ERAS) Protocols. Clin Colon Rectal Surg. 2019 Mar;32(2):121-128. doi: 10.1055/s-0038-1676477. Epub 2019 Feb 28.
PubMed 30833861Machado N, Mortlock R, Maduka R, Souza Cunha AE, Dyer E, Long A, Canner JK, Tanella A, Gibson C, Hyman J, Ogilvie J. Early observations with an ERAS pathway for thyroid and parathyroid surgery: Moving the goalposts forward. Surgery. 2024 Jan;175(1):114-120. doi: 10.1016/j.surg.2023.06.052. Epub 2023 Nov 15.
PubMed 37973430Lee DJ, Chin CJ, Hong CJ, Perera S, Witterick IJ. Outpatient versus inpatient thyroidectomy: A systematic review and meta-analysis. Head Neck. 2018 Jan;40(1):192-202. doi: 10.1002/hed.24934. Epub 2017 Nov 9.
PubMed 29120517
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive Enhanced Recovery After Surgery (ERAS) Protocol for Thyroidectomy
- ClinicalTrials.gov ID
- NCT07575243
- Acronym / sponsor ID
- M.I.Omar-ERAS26
- Conditions
- Thyroid Diseases, Goiter, Thyroid Neoplasms
- Keywords
- Enhanced recovery after surgery, ERAS, Multimodal perioperative care, Length of hospital stay, Thyroidectomy, Opioid-sparing multimodal analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 143 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 May 2025 (actual)
- Study completion
- 31 May 2025 (actual)
- First posted
- 8 May 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.
Thyroidectomy is generally considered a low-to-moderate risk operation; however, postoperative pain, nausea/vomiting, and prolonged hospital stays remain common issues. Enhanced Recovery After Surgery (ERAS) pathways aim to optimize perioperative care and accelerate recovery. This study evaluates the effectiveness and safety of a standardized ERAS pathway in patients undergoing elective thyroidectomy. The prospective ERAS cohort is compared with a historical control group receiving conventional care to assess the impact on the length of hospital stay, postoperative pain, opioid consumption, and complication rates.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ERAS group | – | Procedure: Enhanced Recovery After Surgery protocolA prospective cohort undergoing elective thyroidectomy under an ERAS protocol. |
| Control group | – | Procedure: Conventional perioperative careA historical control cohort undergoing thyroidectomy under conventional care during the 12 months preceding ERAS implementation |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective thyroidectomy for benign or malignant disease at a tertiary cancer institute
Key inclusion criteria (3 listed)
- Patients aged 18-75 years
- ASA physical status I-III.
- Scheduled for elective thyroidectomy for benign or malignant disease.
Key exclusion criteria (3 listed)
- Re-operative thyroid surgery
- Concomitant neck dissection
- Inability to comply with the ERAS pathway
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 |
|---|---|---|
| Enhanced Recovery After Surgery protocolAlso: ERASThis incorporates standardized preoperative counseling, reduced fasting, multimodal opioid-sparing analgesia, total intravenous anesthesia, selective drain use, early oral intake and mobilization, and PTH-guided calcium supplementation | Procedure or surgery | ERAS group |
| Conventional perioperative careThis often involves prolonged preoperative fasting, opioid-based analgesia, and delayed mobilization | Procedure or surgery | Control group |
Primary outcome
Length of hospital stay
Time frame: Up to 30 days post-surgery
Hours from surgery end to discharge
5 secondary outcomes
Postoperative pain scores
Time frame: Assessed in the first 24 hours postoperatively
Total opioid consumption
Time frame: Within first 24 hours
Postoperative nausea and vomiting (PONV)
Time frame: Up to 24 hours postoperatively
Rate of postoperative hypocalcemia
Time frame: First 30 days from the surgery
30-day unplanned readmission rate
Time frame: Up to 30 days postoperative
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 12 May 2026.
- Background: PubMed 38888927Althans AR, Holder-Murray J, Tessler RA. The Future of Enhanced Recovery After Surgery-Precision vs Protocol. JAMA Netw Open. 2024 Jun 3;7(6):e2418968. doi: 10.1001/jamanetworkopen.2024.18968. No abstract available.
- Background: PubMed 38888922Sauro KM, Smith C, Ibadin S, Thomas A, Ganshorn H, Bakunda L, Bajgain B, Bisch SP, Nelson G. Enhanced Recovery After Surgery Guidelines and Hospital Length of Stay, Readmission, Complications, and Mortality: A Meta-Analysis of Randomized Clinical Trials. JAMA Netw Open. 2024 Jun 3;7(6):e2417310. doi: 10.1001/jamanetworkopen.2024.17310.
- Background: PubMed 30833861Simpson JC, Bao X, Agarwala A. Pain Management in Enhanced Recovery after Surgery (ERAS) Protocols. Clin Colon Rectal Surg. 2019 Mar;32(2):121-128. doi: 10.1055/s-0038-1676477. Epub 2019 Feb 28.
- Background: PubMed 37973430Machado N, Mortlock R, Maduka R, Souza Cunha AE, Dyer E, Long A, Canner JK, Tanella A, Gibson C, Hyman J, Ogilvie J. Early observations with an ERAS pathway for thyroid and parathyroid surgery: Moving the goalposts forward. Surgery. 2024 Jan;175(1):114-120. doi: 10.1016/j.surg.2023.06.052. Epub 2023 Nov 15.
- Background: PubMed 29120517Lee DJ, Chin CJ, Hong CJ, Perera S, Witterick IJ. Outpatient versus inpatient thyroidectomy: A systematic review and meta-analysis. Head Neck. 2018 Jan;40(1):192-202. doi: 10.1002/hed.24934. Epub 2017 Nov 9.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Thyroid Diseases and Goiter, run by Assiut 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 3 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 12 May 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 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?
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?
Length of hospital stay (time frame: Up to 30 days post-surgery). 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 NCT07575243, 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 12 May 2026.