- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07832838
ERAS Versus Conventional Care Following Gynecological Laparoscopic Surgery
Enhanced Recovery After Surgery (ERAS) Versus Conventional Perioperative Care Following Gynaecological Laparoscopic Surgery: A Prospective Comparative Study
This prospective randomized comparative study aims to compare Enhanced Recovery After Surgery (ERAS) protocol versus conventional perioperative care in women undergoing benign gynecological laparoscopic surgery. The primary outcome is quality of recovery assessed by QoR-15 score at 24 hours. Secondary outcomes include hospital stay, pain scores, bowel function, ambulation, analgesic consumption, PONV, complications, readmission, patient satisfaction and hospital cost.
Přehled studie
Postavení
Podmínky
Detailní popis
Laparoscopic surgery is the standard approach for many benign gynecological conditions due to less tissue trauma, less pain and faster recovery. However perioperative care practices vary significantly and affect recovery.
Enhanced Recovery After Surgery (ERAS) is a multidisciplinary evidence-based pathway designed to reduce surgical stress and accelerate recovery. ERAS includes preoperative counseling and avoidance of prolonged fasting with clear fluids up to 2 hours and carbohydrate loading, no routine mechanical bowel preparation, standardized anesthesia with multimodal opioid-sparing analgesia, goal-directed fluid therapy, active warming, postoperative nausea and vomiting prophylaxis, avoidance of drains, early oral intake, early mobilization and early urinary catheter removal.
This study will randomize 100 women aged 18 to 60 years with ASA I-III scheduled for benign gynecological laparoscopic surgery into two groups in 1 to 1 ratio using computer-generated randomization. Group A will receive ERAS pathway and Group B will receive conventional care including NPO after midnight, bowel preparation with Prepawest, conventional NSAID analgesia, delayed feeding until bowel sounds return, and catheter retention until discharge.
All patients will be followed for 30 days. Primary outcome is QoR-15 at 24 hours. Secondary outcomes include VAS pain at 6, 12 and 24 hours, time to flatus, bowel movement, oral intake, ambulation, total analgesic consumption, PONV, complications classified by Clavien-Dindo, 30-day readmission, patient satisfaction and total hospital cost.
Data will be analyzed using SPSS with t-test or Mann-Whitney for continuous variables and Chi-square or Fisher exact for categorical variables. P less than 0.05 is considered significant.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: sara M Farouk, resident
- Telefonní číslo: 0 11 59002779
- E-mail: sameha.18313614@med.aun.edu.eg
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Women aged 18-60 years
- Indicated for benign gynaecologic laparoscopic surgery
- ASA physical status I-III
- Ability to provide informed consent
Exclusion Criteria:
- Pregnancy
- Suspected gynecologic malignancy
- Conversion to laparotomy
- Severe systemic disease preventing ERAS implementation
- Inability to comply with follow-up
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Podpůrná péče
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Experimentální: ERAS Group
ERAS protocol with counseling avoidance of prolonged fasting carb loading multimodal analgesia early feeding early mobilization early catheter removal |
Comprehensive ERAS pathway For Arm: ERAS Group |
|
Aktivní komparátor: Conventional Care Group
Conventional care with NPO after midnight bowel prep with Prepawest conventional NSAIDs delayed feeding catheter until discharge discharge by surgeon discretion |
Standard routine care For Arm: Conventional Care Group |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Quality of Recovery-15 score at 24 hours
Časové okno: At 24 hours after surgery
|
Quality of Recovery-15 score measured by QoR-15 questionnaire from 0 to 150 higher score means better recovery |
At 24 hours after surgery
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Length of postoperative hospital stay
Časové okno: Up to 30 days
|
Length of stay measured in hours from end of surgery to discharge |
Up to 30 days
|
|
Postoperative pain score at 6 hours
Časové okno: At 6 hours after surgery
|
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain |
At 6 hours after surgery
|
|
Postoperative pain score at 12 hours
Časové okno: At 12 hours after surgery
|
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain |
At 12 hours after surgery
|
|
Postoperative pain score at 24 hours
Časové okno: At 24 hours after surgery
|
Pain score measured by Visual Analogue Scale from 0 to 10 higher score means worse pain |
At 24 hours after surgery
|
|
Time to first flatus
Časové okno: Up to 48 hours
|
Time to first flatus measured in hours from end of surgery |
Up to 48 hours
|
|
Time to first bowel movement
Časové okno: Up to 48 hours
|
Time to first bowel movement measured in hours from end of surgery |
Up to 48 hours
|
|
Time to first oral intake
Časové okno: Up to 48 hours
|
Time to first oral intake measured in hours from end of surgery |
Up to 48 hours
|
|
Time to first ambulation
Časové okno: Up to 48 hours
|
Time to first ambulation measured in hours from end of surgery |
Up to 48 hours
|
|
Total analgesic consumption
Časové okno: Within 24 hours after surgery
|
Total analgesic consumption in milligrams within first 24 hours |
Within 24 hours after surgery
|
|
Number of participants with postoperative nausea and vomiting
Časové okno: Within 24 hours after surgery
|
Number of participants who develop postoperative nausea and vomiting |
Within 24 hours after surgery
|
|
Number of participants with postoperative complications
Časové okno: Up to 30 days
|
Number of participants with postoperative complications classified by Clavien-Dindo classification |
Up to 30 days
|
|
Number of participants with 30-day readmission
Časové okno: Up to 30 days
|
Number of participants requiring hospital readmission within 30 days |
Up to 30 days
|
|
Patient satisfaction score
Časové okno: At 24 hours after surgery
|
Patient satisfaction score measured on 0 to 10 scale higher score means greater satisfaction |
At 24 hours after surgery
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Studijní židle: Mahmoud S Mohamed, prof, obstetrics and gynaecology Department, Assiut University Hospitals, Assiut, Egypt
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ERAS-GynLap-Assiut-28
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