Enhanced Recovery After Surgery in Hysterectomy Patients (ERAS)
Effectiveness of Enhanced Recovery After Surgery (ERAS) Protocols in Hysterectomy Patients. A Prospective,Randomized Controlled Clinical Trial.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Enhanced Recovery After Surgery (ERAS) protocols are structured, multidisciplinary perioperative care pathways developed to optimize surgical outcomes by minimizing physiological stress and promoting early recovery. These protocols include preoperative counseling, shortened fasting with carbohydrate loading, opioid-sparing anesthesia, early feeding, and early mobilization.
Hysterectomy remains one of the most common gynecological procedures worldwide and is often associated with prolonged hospital stay and postoperative morbidity, particularly in resource-limited settings. While international evidence supports the benefits of ERAS in improving outcomes such as reduced length of hospital stay, improved pain control, and decreased complications, there is a need for locally generated data to validate its effectiveness in Egyptian tertiary healthcare settings.
This study will be conducted at Kasr Al-Ainy Hospital, Cairo University, and will include women undergoing elective hysterectomy for benign or early-stage malignant gynecological conditions. Participants will be randomly assigned to either the ERAS group or the conventional care group. Outcomes will be assessed during hospitalization and up to 30 days postoperatively.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Ehab H Sorour, MD
- Telefonnummer: +201112496821
- E-post: dr.ehabsorour@gmail.com
Studera Kontakt Backup
- Namn: Mohamed E El Mahy, MD
- Telefonnummer: +201111831716
- E-post: mohammed.elmahy@kasralainy.edu.eg
Studieorter
-
-
-
Cairo, Egypten
- Faculty of Medicine-Cairo University
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
Inclusion Criteria:
- Women aged 18-70 years.
- Undergoing elective total hysterectomy for benign or early stage malignant gynacological conditions .
- ASA ( American Society of Anesthesiologists ) physical status I-II.
- Able to provide informed consent.
Exclusion Criteria:
- Emergency hysterectomy
- Advanced malignant requiring extensive debulking
- Known bowel disease or previous bowel surgery ( crohn's disease , bowel obstruction )
- Significant cognitive impairment or psychiatric illness
- Inability to follow ERAS protocol (e.g., cognitive impairment)
- Refusal to participate
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Stödjande vård
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Aktiv komparator: ERAS group
Preoperative counseling Reduced fasting and carbohydrate loading Standardized anesthesia with reduced opioid use Early oral feeding Early mobilization Multimodal analgesia IV dextrose infusion (5%) 500 ml once or apple juice( 200-400 mL) 2-3 hours before anesthesia
|
IV dextrose infusion (5%) 500 ml once ,2-3 hours before anesthesia
Reduced fasting Early oral feeding Early mobilization
|
|
Inget ingripande: Conventional care
Overnight fasting Delayed postoperative feeding Opioid-based analgesia Delayed mobilization Routine prolonged use of drains/catheters
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
length of hospital stay (LOS)
Tidsram: From day of surgery up to 7 postoperative days
|
Time from completion of surgery to hospital discharge readiness, measured in days.
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From day of surgery up to 7 postoperative days
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
postoperative pain score
Tidsram: At 12 and 24 hours postoperatively
|
Postoperative pain intensity measured using the Visual Analog Scale (VAS), a 10-cm scale ranging from 0 (no pain) to 10 (worst imaginable pain).
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At 12 and 24 hours postoperatively
|
|
time to first bowel movement
Tidsram: Up to 5 postoperative days
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the interval (in hours) from completion of surgery to the first documented passage of stool."
|
Up to 5 postoperative days
|
Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Ehab H Sorour, MD, Cairo University
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- MS-729-2025
Plan för individuella deltagardata (IPD)
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