- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07915960
Comparison of Post-operative Outcomes Between ERAS Protocol and Non-ERAS Local Regimen in Patients Undergoing Thyroidectomy
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Tehreem H Doctor, MBBS
- Telefonnummer: +923041696479
- E-mail: t.hannan95@gmail.com
Studiesteder
-
-
Punjab Province
-
Faisalabad, Punjab Province, Pakistan
- Rekruttering
- Allied Hospital Faisalabad
-
Kontakt:
- Tehreem H Doctor, MBBS
- Telefonnummer: +923041696479
- E-mail: t.hannan95@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Ambulation time
Tidsramme: 6 months
|
Ambulation time in hours will be compared after applying ERAS protocol and non ERAS local regimen |
6 months
|
|
Length of hospital stay
Tidsramme: 6 months
|
Length of hospital stay will be measured in days after applying ERAS protocol and non ERAS local regimen |
6 months
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 08-2026
Plan for individuelle deltagerdata (IPD)
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