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临床试验/CTRI/2025/11/096774
CTRI/2025/11/096774尚未招募1 期

A prospective comparative study of Enhanced Recovery After Surgery Protocol vs standard protocol of care in gynaecological surgeries

Kasturi Laxmi Maanasa1 个研究点 分布在 1 个国家目标入组 108 人开始时间: 2025年11月14日最近更新:

试验速览

阶段
1 期
状态
尚未招募
发起方
入组人数
108
试验地点
1
主要终点
To evaluate ERAS protocol implementation and its effect on recovery post-operation POST OPERATIVE DAY 0, 1, 2

研究概览

简要总结

Hysterectomy ranks among the most frequently conducted major surgical interventions in the field of gynecology.

However, the availability of newer and less invasive treatment choices for gynecological conditions has led to a decline in the prevalence of total abdominal hysterectomy (TAH) with or without salpingo-oophorectomy, particularly in developed countries.

The complexity of inpatient gynecologic surgeries varies significantly from straightforward hysterectomies to intricate cytoreductive cancer surgeries.  Surgical interventions create significant stress on the body, disrupting homeostasis and triggering physiological changes.  This stress response leads to increased carbohydrate metabolism, elevated cardiac output, and insulin resistance, potentially resulting in relative hypoxia, impaired coagulation, and altered gastrointestinal and pulmonary function.  These physiological disturbances can delay recovery, prolong hospital stays and increase the risk of postoperative complications.  Extended hospitalization directly contributes to higher health care costs and longer sick leave, which adds to the overall socioeconomic burden. The primary objectives of preoperative and postoperative protocols are to promote faster recovery, minimize postoperative complications, and shorten hospital stays.

Kehlet first introduced the Enhanced Recovery After Surgery (ERAS) protocol, which represents a strategic approach aimed at optimizing perioperative care. The ERAS protocol aims to achieve homeostasis, minimize surgical trauma, reduction in inflammation and stress, and promote a faster recovery to baseline function after surgery. The core principles of ERAS encompass preoperative counseling, minimized perioperative fasting, prompt resumption of oral intake, and early postoperative mobilization, opioid-sparing pain management, regional anesthesia, minimally invasive surgical techniques, goal-directed IV fluid management, and restricted usage of surgical drains and tubes. Studies have shown that implementing ERAS protocols significantly reduces hospital length of stay and postoperative complications across various surgical specialties, including Colo-rectal urologic and gynecologic oncology, without raising the frequency of return to the healthcare system.

Thus, we have conducted this study to determine the Efficacy and outcome of the ERAS protocol in comparison to the standard protocol of care in major gynecological surgeries.

研究设计

研究类型
Interventional
分配方式
Other
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
Female

入选标准

  • Age more than 18 years Abdominal hysterectomy Regional anesthesia Elective cases.

排除标准

  • Untreated anemia Bleeding disorders Infections Cardiopulmonary diseases Gastrointestinal diseases Suspected cases of malignancy Severe neurological illnesses Underlying diseases affecting the quality of life and nutritional condition.

结局指标

主要结局

To evaluate ERAS protocol implementation and its effect on recovery post-operation POST OPERATIVE DAY 0, 1, 2

时间窗: To evaluate ERAS protocol implementation and its effect on recovery post-operation on post operative day 0,1,2

次要结局

  • To assess the impact of ERAS protocol implementation on postoperative recovery, that is, early mobilization, return to normal feeding, duration of hospital stay & complication rates.(1 day)

研究者

发起方
Kasturi Laxmi Maanasa
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Kasturi Laxmi Maanasa

BLDE (DU) SHRI B M PATIL MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE

研究点 (1)

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