NCT07575243

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
143

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2024

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 31, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

1.1 years

First QC Date

May 2, 2026

Last Update Submit

May 2, 2026

Conditions

Keywords

Enhanced recovery after surgeryERASMultimodal perioperative careLength of hospital stayThyroidectomyOpioid-sparing multimodal analgesia

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Hours from surgery end to discharge

    Up to 30 days post-surgery

Secondary Outcomes (5)

  • Postoperative pain scores

    Assessed in the first 24 hours postoperatively

  • Total opioid consumption

    Within first 24 hours

  • Postoperative nausea and vomiting (PONV)

    Up to 24 hours postoperatively

  • Rate of postoperative hypocalcemia

    First 30 days from the surgery

  • 30-day unplanned readmission rate

    Up to 30 days postoperative

Study Arms (2)

ERAS group

A prospective cohort undergoing elective thyroidectomy under an ERAS protocol.

Procedure: Enhanced Recovery After Surgery protocol

Control group

A historical control cohort undergoing thyroidectomy under conventional care during the 12 months preceding ERAS implementation

Procedure: Conventional perioperative care

Interventions

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

Also known as: ERAS
ERAS group

This often involves prolonged preoperative fasting, opioid-based analgesia, and delayed mobilization

Control group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for elective thyroidectomy for benign or malignant disease at a tertiary cancer institute

You may qualify if:

  • Patients aged 18-75 years
  • ASA physical status I-III.
  • Scheduled for elective thyroidectomy for benign or malignant disease.

You may not qualify if:

  • Re-operative thyroid surgery
  • Concomitant neck dissection
  • Inability to comply with the ERAS pathway

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Surgical Oncology Department, South Egypt Cancer Institute, Assiut University

Asyut, Asyut Governorate, 71516, Egypt

Location

Related Publications (5)

  • 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.

    PMID: 38888927BACKGROUND
  • Sauro 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.

    PMID: 38888922BACKGROUND
  • Simpson 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.

    PMID: 30833861BACKGROUND
  • Machado 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.

    PMID: 37973430BACKGROUND
  • Lee 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.

    PMID: 29120517BACKGROUND

MeSH Terms

Conditions

Thyroid DiseasesGoiterThyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine System DiseasesEndocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck Neoplasms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, Surgical Oncology Department

Study Record Dates

First Submitted

May 2, 2026

First Posted

May 8, 2026

Study Start

May 1, 2024

Primary Completion

May 31, 2025

Study Completion

May 31, 2025

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations