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Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy

31 oktober 2026 uppdaterad av: Tehreem Hannan, Allied Hospital Faisalabad

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Interventionell

Inskrivning (Beräknad)

96

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

    • Punjab Province
      • Faisalabad, Punjab Province, Pakistan
        • Rekrytering
        • Allied Hospital Faisalabad
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 60 år (Vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

Inclusion Criteria:

  1. Patients aged 18-60 years.
  2. Patients scheduled for elective subtotal, near-total, or total thyroidectomy.
  3. Patients with ASA physical status I-III.
  4. Patients with acceptable preoperative haematological, hepatic, and renal function and thyroid function adequately controlled for elective surgery.
  5. Patients willing to complete the planned four-week follow-up.
  6. Patients providing voluntary written informed consent for participation in the study.

Exclusion Criteria:

  1. Patients undergoing thyroid lobectomy with or without isthmusectomy.
  2. Patients undergoing emergency thyroid surgery.
  3. Patients with ASA physical status greater than III.
  4. Pregnant patients.
  5. Patients with type I or type II diabetes mellitus.
  6. Patients unwilling to participate in the study or withdrawing consent before random allocation.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Stödjande vård
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: ERAS protocol group

Patients undergoing thyroidectomy managed with the Enhanced Recovery After Surgery (ERAS) perioperative care protocol.

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

Aktiv komparator: Non- ERAS local regimen

Patients undergoing thyroidectomy managed with standard local perioperative care regimens without ERAS implementation.

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Ambulation time
Tidsram: 6 months

Ambulation time in hours will be compared after applying ERAS protocol and non ERAS local regimen

6 months
Length of hospital stay
Tidsram: 6 months

Length of hospital stay will be measured in days after applying ERAS protocol and non ERAS local regimen

6 months

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 maj 2026

Primärt slutförande (Beräknad)

14 november 2026

Avslutad studie (Beräknad)

19 november 2026

Studieregistreringsdatum

Först inskickad

30 september 2026

Först inskickad som uppfyllde QC-kriterierna

31 oktober 2026

Första postat (Faktisk)

4 november 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 november 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

31 oktober 2026

Senast verifierad

1 oktober 2026

Mer information

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