- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving 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
Studieoversikt
Status
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Støttende omsorg
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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 |
|
Aktiv 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
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Post operative insuline resistance
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Time to first oral intake
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- RCT-ERAS-2026-01
Plan for individuelle deltakerdata (IPD)
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