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.
調査の概要
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前:Tehreem H Doctor, MBBS
- 電話番号:+923041696479
- メール:t.hannan95@gmail.com
研究場所
-
-
Punjab Province
-
Faisalabad、Punjab Province、パキスタン
- 募集
- Allied Hospital Faisalabad
-
コンタクト:
- Tehreem H Doctor, MBBS
- 電話番号:+923041696479
- メール:t.hannan95@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:支持療法
- 割り当て:ランダム化
- 介入モデル:並列代入
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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 |
|
アクティブコンパレータ: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 |
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ambulation time
時間枠:6 months
|
Ambulation time in hours will be compared after applying ERAS protocol and non ERAS local regimen |
6 months
|
|
Length of hospital stay
時間枠:6 months
|
Length of hospital stay will be measured in days after applying ERAS protocol and non ERAS local regimen |
6 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。