- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07562776
A Comparative Study of Preoperative Carbohydrate Loading Dose and Fasting on Postoperative Recovery Time in Elective Abdominal Surgery Patients
Title: A Comparative Study of Preoperative Carbohydrate Loading Dose and Fasting on Postoperative Recovery Time in Elective Abdominal Surgery Patients
Studienübersicht
Status
Detaillierte Beschreibung
Preoperative fasting has traditionally been practiced to reduce the risk of aspiration during anesthesia; however, prolonged fasting may lead to increased insulin resistance, patient discomfort, and delayed postoperative recovery. Recent evidence suggests that preoperative carbohydrate loading may improve metabolic response and enhance recovery after surgery.
This single-center randomized controlled trial will be conducted on 144 patients admitted for elective abdominal surgery. Eligible participants will be randomly allocated into two groups: the intervention group will receive a standardized preoperative carbohydrate drink within a defined time before surgery, while the control group will follow conventional fasting guidelines.
The primary outcome of the study is postoperative recovery time, assessed using clinically relevant recovery parameters. Secondary outcomes include length of hospital stay, incidence of postoperative complications, and patient-reported comfort measures.
Data will be collected prospectively during hospital stay and analyzed to determine whether preoperative carbohydrate loading provides significant benefits over standard fasting protocols. The results of this study may contribute to improving perioperative care practices and updating fasting guidelines in surgical patients.
Studientyp
Einschreibung (Geschätzt)
Phase
- Unzutreffend
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
• Patients aged 20-60
- ASA I-II classification.
- Elective open or laparoscopic abdominal surgeries.
Exclusion Criteria:
• Diabetes mellitus or impaired fasting glucose.
- Emergency surgeries.
- Patients with hepatic or renal dysfunction.
- Patients on corticosteroids or insulin-sensitizing agents.
- Pregnant patients.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Unterstützende Pflege
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Pre operative carbohydrate Loading group
Patients in this group will receive a preoperative carbohydrate-rich clear liquid drink before elective abdominal surgery to reduce insulin resistance, improve postoperative recovery, and decrease discomfort associated with prolonged fasting.
|
Most previous studies have evaluated preoperative carbohydrate loading in mixed surgical populations or in settings outside Pakistan. Limited local data exist specifically for elective abdominal surgery patients in a single-center Pakistani tertiary care hospital setting. Thisstudy focuses on comparing a standardized carbohydrate loading dose with conventional fasting and assessing its direct impact on postoperative recovery time in your local population. surgery patients specifically It uses a standardized carbohydrate loading dose It compares against the routinely practiced prolonged fasting protocol It is conducted in a single-center local hospital population, where local evidence is limited It focuses on postoperative recovery time as the primary clinical outcome |
|
Aktiver Komparator: Standard preoperative fasting group
Patients in this group will follow the routine preoperative fasting protocol as per hospital practice, including overnight fasting from solids and clear liquids according to standard anesthetic guidelines before elective abdominal surgery.
No preoperative carbohydrate drink will be administered.
Postoperative recovery outcomes will be compared with the intervention group receiving preoperative carbohydrate loading.
|
Patients in this group will follow the routine preoperative fasting protocol according to hospital and anesthesia guidelines, including overnight fasting from solids and clear liquids before elective abdominal surgery.
No preoperative carbohydrate loading will be give
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Post operative insuline resistance
Zeitfenster: 24 hours after surgery
|
To evaluate the effect of preoperative oral carbohydrate loading compared with standard fasting on postoperative insulin resistance in patients undergoing elective abdominal surgery.
Insulin resistance will be assessed by measuring fasting blood glucose and serum insulin levels preoperatively and postoperatively, and calculating insulin resistance using the Homeostatic Model Assessment for Insulin Resistance (HOMA-IR).
|
24 hours after surgery
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Time to first oral intake
Zeitfenster: 24 hours after surgery
|
To compare the duration from completion of surgery until the patient tolerates first oral intake (clear fluids or oral diet) between the preoperative carbohydrate loading group and the standard fasting group.
This outcome reflects early postoperative gastrointestinal recovery and readiness for oral feeding.
|
24 hours after surgery
|
Mitarbeiter und Ermittler
Sponsor
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Andere Studien-ID-Nummern
- RCT-ERAS-2026-01
Plan für individuelle Teilnehmerdaten (IPD)
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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