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ERAS Versus Conventional Care Following Gynecological Laparoscopic Surgery

16. september 2026 opdateret af: Sara Mohamed Farouk, Assiut University

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.

Studieoversigt

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

100

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Aktiv komparator: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Quality of Recovery-15 score at 24 hours
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Length of postoperative hospital stay
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 48 hours

Time to first flatus measured in hours from end of surgery

Up to 48 hours
Time to first bowel movement
Tidsramme: 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
Tidsramme: Up to 48 hours

Time to first oral intake measured in hours from end of surgery

Up to 48 hours
Time to first ambulation
Tidsramme: Up to 48 hours

Time to first ambulation measured in hours from end of surgery

Up to 48 hours
Total analgesic consumption
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Up to 30 days

Number of participants requiring hospital readmission within 30 days

Up to 30 days
Patient satisfaction score
Tidsramme: At 24 hours after surgery

Patient satisfaction score measured on 0 to 10 scale higher score means greater satisfaction

At 24 hours after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Studiestol: Mahmoud S Mohamed, prof, obstetrics and gynaecology Department, Assiut University Hospitals, Assiut, Egypt

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

20. september 2026

Primær færdiggørelse (Anslået)

20. september 2027

Studieafslutning (Anslået)

1. maj 2028

Datoer for studieregistrering

Først indsendt

16. september 2026

Først indsendt, der opfyldte QC-kriterier

16. september 2026

Først opslået (Faktiske)

22. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. september 2026

Sidst verificeret

1. september 2026

Mere information

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