NCT06274970

Brief Summary

Enhanced recovery after surgery (ERASP) are evidence-based perioperative protocols devised to expedite postoperative recovery and discharge, decrease surgical stress and costs. However, there is limited data on their use and effectiveness in thyroid and parathyroid surgery. Aim of PaThERAS study is to investigate the clinical benefits and cost-effectiveness of enhanced recovery protocols for the perioperative management in patients undergoing total thyroidectomy for large goiters/ cancers and parathyroidectomy for symptomatic hyperparathyroidism in non-day-care setting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

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

January 25, 2023

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 16, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2024

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 25, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2024

Completed
Last Updated

January 7, 2025

Status Verified

January 1, 2025

Enrollment Period

1.7 years

First QC Date

January 16, 2024

Last Update Submit

January 4, 2025

Conditions

Thyroid DiseasesParathyroid DiseasesERAS

Keywords

ERAS ProtocolsEnhanced Recovery After Surgery ProtocolsThyroid SurgeryParathyroid SurgeryPaThERAS

Outcome Measures

Primary Outcomes (1)

  • To compare the rate of hypocalcemia in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols

    S. Calcium levels will be measured. Levels \>8mg/dl were considered normal

    Post operative day 1, 2 & 7

Secondary Outcomes (4)

  • To compare length of hospital stay in patients undergoing thyroid and parathyroid surgery in days

    from date of surgery till Post operative Day 7

  • To compare hospital costs in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols

    from date of surgery till Post operative Day 7

  • To compare postoperative complication rates in patients undergoing thyroid and parathyroid surgery implementing Enhanced recovery after surgery protocols vs Conventional peri operative protocols

    from date of surgery till 6 months post surgery

  • To compare readmission rate

    from date of surgery till 6 months post surgery

Study Arms (2)

ERAS Group

EXPERIMENTAL

Those patients who follow ERAS protocols preoperatively, intraoperatively and post operatively

Other: Enhanced recovery protocols

Conventional Group

ACTIVE COMPARATOR

Those patients who conventional protocols preoperatively, intraoperatively and post operatively

Other: Conventional Protocols

Interventions

Enhanced recovery protocolsOTHER

Aforementioned in the detailed description

ERAS Group
Conventional ProtocolsOTHER

Conventional protocols for non-ERASP group Eg: No preoperative vitamin D and calcium supplementation etc.

Conventional Group

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed to have ASA Grade 1 and Grade 2 patients with thyroid and/or parathyroid (1° and 2° hyperparathyroidism) disease undergoing the following procedures via open or endoscopic approach • Total thyroidectomy/Focused parathyroidectomy/BNE with excision of enlarged glands +/- any additional procedure (Eg: Central compartment neck dissection, Lateral neck dissection, Cervical thymectomy etc)

You may not qualify if:

  • Patients undergoing thyroid and/or parathyroid surgery who
  • Undergo hemithyroidectomy
  • Refuse to consent to participate in the study in the cohort group
  • ASA Grade 3 and Grade 4\* \*Comorbidities of severe nature which may independently impact perioperative hospital stay, complications and outcomes in the study and control group

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sanjay Gandhi Post Graduate Institute of Medical Sciences

Lucknow, Uttar Pradesh, 226014, India

Location

Related Publications (6)

  • Chorath K, Luu N, Go BC, Moreira A, Rajasekaran K. ERAS Protocols for Thyroid and Parathyroid Surgery: A Systematic Review and Meta-analysis. Otolaryngol Head Neck Surg. 2022 Mar;166(3):425-433. doi: 10.1177/01945998211019671. Epub 2021 Jun 15.

    PMID: 34126805BACKGROUND

  • Smith TW Jr, Wang X, Singer MA, Godellas CV, Vaince FT. Enhanced recovery after surgery: A clinical review of implementation across multiple surgical subspecialties. Am J Surg. 2020 Mar;219(3):530-534. doi: 10.1016/j.amjsurg.2019.11.009. Epub 2019 Nov 16.

    PMID: 31761300BACKGROUND

  • Dort JC, Farwell DG, Findlay M, Huber GF, Kerr P, Shea-Budgell MA, Simon C, Uppington J, Zygun D, Ljungqvist O, Harris J. Optimal Perioperative Care in Major Head and Neck Cancer Surgery With Free Flap Reconstruction: A Consensus Review and Recommendations From the Enhanced Recovery After Surgery Society. JAMA Otolaryngol Head Neck Surg. 2017 Mar 1;143(3):292-303. doi: 10.1001/jamaoto.2016.2981.

    PMID: 27737447BACKGROUND

  • Terris DJ, Snyder S, Carneiro-Pla D, Inabnet WB 3rd, Kandil E, Orloff L, Shindo M, Tufano RP, Tuttle RM, Urken M, Yeh MW; American Thyroid Association Surgical Affairs Committee Writing Task Force. American Thyroid Association statement on outpatient thyroidectomy. Thyroid. 2013 Oct;23(10):1193-202. doi: 10.1089/thy.2013.0049. Epub 2013 Sep 14.

    PMID: 23742254BACKGROUND

  • Xing T, Hu Y, Wang B, Zhu J. Role of oral calcium supplementation alone or with vitamin D in preventing post-thyroidectomy hypocalcaemia: A meta-analysis. Medicine (Baltimore). 2019 Feb;98(8):e14455. doi: 10.1097/MD.0000000000014455.

    PMID: 30813146BACKGROUND

  • Khatiwada AS, Harris AS. Use of pre-operative calcium and vitamin D supplementation to prevent post-operative hypocalcaemia in patients undergoing thyroidectomy: a systematic review. J Laryngol Otol. 2021 Jul;135(7):568-573. doi: 10.1017/S0022215121001523. Epub 2021 Jun 14.

    PMID: 34120662BACKGROUND

MeSH Terms

Conditions

Thyroid DiseasesParathyroid Diseases

Condition Hierarchy (Ancestors)

Endocrine System Diseases

Study Officials

  • Gaurav Agarwal, MS

    gauravbsi@gmail.com

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head of Department Endocrine and Breast Surgery

Study Record Dates

First Submitted

January 16, 2024

First Posted

February 23, 2024

Study Start

January 25, 2023

Primary Completion

September 25, 2024

Study Completion

September 25, 2024

Last Updated

January 7, 2025

Record last verified: 2025-01

Locations

IN(1)