跳至主要内容
临床试验/NCT07832838
NCT07832838尚未招募不适用

Enhanced Recovery After Surgery (ERAS) Versus Conventional Perioperative Care Following Gynaecological Laparoscopic Surgery: A Prospective Comparative Study

Assiut University0 个研究点目标入组 100 人开始时间: 2026年9月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
主要终点
Quality of Recovery-15 score at 24 hours

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Women aged 18-60 years
  • Indicated for benign gynaecologic laparoscopic surgery
  • ASA physical status I-III
  • Ability to provide informed consent

排除标准

  • Pregnancy
  • Suspected gynecologic malignancy
  • Conversion to laparotomy
  • Severe systemic disease preventing ERAS implementation
  • Inability to comply with follow-up

研究组 & 干预措施

ERAS Group

Experimental

ERAS protocol with counseling avoidance of prolonged fasting carb loading multimodal analgesia early feeding early mobilization early catheter removal

干预措施: Enhanced Recovery After Surgery Protocol (Other)

Conventional Care Group

Active Comparator

Conventional care with NPO after midnight bowel prep with Prepawest conventional NSAIDs delayed feeding catheter until discharge discharge by surgeon discretion

干预措施: Conventional Perioperative Care (Other)

结局指标

主要结局

Quality of Recovery-15 score at 24 hours

时间窗: At 24 hours after surgery

Quality of Recovery-15 score measured by QoR-15 questionnaire from 0 to 150 higher score means better recovery

次要结局

  • Length of postoperative hospital stay(Up to 30 days)
  • Postoperative pain score at 6 hours(At 6 hours after surgery)
  • Postoperative pain score at 12 hours(At 12 hours after surgery)
  • Postoperative pain score at 24 hours(At 24 hours after surgery)
  • Time to first flatus(Up to 48 hours)
  • Time to first bowel movement(Up to 48 hours)
  • Time to first oral intake(Up to 48 hours)
  • Time to first ambulation(Up to 48 hours)
  • Total analgesic consumption(Within 24 hours after surgery)
  • Number of participants with postoperative nausea and vomiting(Within 24 hours after surgery)
  • Number of participants with postoperative complications(Up to 30 days)
  • Number of participants with 30-day readmission(Up to 30 days)
  • Patient satisfaction score(At 24 hours after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sara Mohamed Farouk

Resident physician

Assiut University

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