Enhanced Recovery Protocols in Gynecological Cancer Patients: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 600
- 试验地点
- 8
- 主要终点
- Duration of hospitalization
研究概览
简要总结
Enhanced Recovery After Surgery (ERAS) are developed to provide a systematic structure for managing postsurgical patients.These protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. The present study aims to investigate the feasibility of and compliance to a structured ERAS protocol among Gynecological Oncological Centers in Greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in ERAS protocols but did not meet the sufficient necessary criteria.
详细描述
Enhanced Recovery After Surgery (ERAS) are developed to provide a systematic structure for managing postsurgical patients.These protocols promote evidenced-based practices and implement a multidisciplinary effort to maintain normal physiology in the perioperative period and aid in earlier recovery. ERAS protocols briefly include pre-admission education, pre-operative nutritional care, specific recommendations for pre-operative medications, a standardized anesthetic protocol, perioperative fluid management, multimodal analgesia (MMA), early mobilization, and early removal of urinary catheters.
ERGO study study aims to investigate the feasibility of and compliance to a structured ERAS protocol among Gynecological Oncological Centers in Greece as well as to compare the outcomes among patients that fullfilled the minimum number of necessary criteria, compared to those that were enrolled in ERAS protocols but did not meet the sufficient necessary criteria. Patients will be registered into the trial before surgery. Quality assurance program will be in place for both patients that will fulfill the ERAS criteria as well as for those that will not fulfill them.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 25 Years 至 85 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •patients with gynaecological cancer and an ECOG performance status <4, ASA score <4.
排除标准
- •patients with metastatic cancer of non-gynaecological origin patients that are not able to follow ERAS protocol due to medical reasons patients with severe debilitating comorbidities (ECOG status 4, ASA score 4-5)
结局指标
主要结局
Duration of hospitalization
时间窗: Up to 30 days postoperatively
From date of hospitalization until the date of discharge or date of death from any cause, whichever came first, assessed up to 2 months.
Perioperative infections
时间窗: Postoperatively (30 days)
Number of participants with postoperative infections (including surgical site, pulmonary and urinary tract infections)
次要结局
- Postoperative quality of life(Postoperatively (30 days))
- Postoperative morbidity (other than infectious) using the Clavien-Dindo classification(30 days)
- Interval to adjuvant therapy(Up to 100 days)
- Recurrence rates(3 years follow-up)
- Overall survival(3 years follow-up)
研究者
Nikolaos Thomakos
MD, PhD, MSc, Associate Professor of Obstetrics and Gynecology
National and Kapodistrian University of Athens