- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: sara M Farouk, resident
- 전화번호: 0 11 59002779
- 이메일: sameha.18313614@med.aun.edu.eg
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: 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 |
|
활성 비교기: 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 |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Quality of Recovery-15 score at 24 hours
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Length of postoperative hospital stay
기간: 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
기간: 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
기간: 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
기간: 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
기간: Up to 48 hours
|
Time to first flatus measured in hours from end of surgery |
Up to 48 hours
|
|
Time to first bowel movement
기간: 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
기간: Up to 48 hours
|
Time to first oral intake measured in hours from end of surgery |
Up to 48 hours
|
|
Time to first ambulation
기간: Up to 48 hours
|
Time to first ambulation measured in hours from end of surgery |
Up to 48 hours
|
|
Total analgesic consumption
기간: 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
기간: 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
기간: 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
기간: Up to 30 days
|
Number of participants requiring hospital readmission within 30 days |
Up to 30 days
|
|
Patient satisfaction score
기간: At 24 hours after surgery
|
Patient satisfaction score measured on 0 to 10 scale higher score means greater satisfaction |
At 24 hours after surgery
|
공동 작업자 및 조사자
수사관
- 연구 의자: Mahmoud S Mohamed, prof, obstetrics and gynaecology Department, Assiut University Hospitals, Assiut, Egypt
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- ERAS-GynLap-Assiut-28
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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