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临床试验/NCT06226753
NCT06226753Unknown不适用

Impact of General Anesthesia v/s Spinal Anesthesia on Enhanced Recovery After Surgery (ERAS) Parameters in Intestinal Stoma Reversal: A Randomised Control Trial

All India Institute of Medical Sciences, Bhubaneswar2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年2月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Time to passage of flatus

研究概览

简要总结

Randomized, Interventional ,Open labeled, Parallel Assignment and Superiority trial.

详细描述

Temporary intestinal stomas are commonly created in emergency and elective surgeries to divert intestinal contents from distal anastomoses site or after resection of a diseased bowel segment. They however increase the morbidity of a patient, impacting the life of a patient socially and psychologically. A timely and planned early stoma reversal can reduce various stoma related complications (up to 71%) like parastomal leakage, dermatitis, prolapse, retraction, dehydration, electrolyte imbalance and acute kidney injury, and occasionally requirement of parenteral nutrition. However these patients are often subject to long waiting periods for want of availability of a slot under general anaesthesia. More importantly, quite some of these patients with temporary stoma have poor general condition and comorbidity prohibiting a timely stoma closure. Closing intestinal stomas under regional anaesthesia could have partially addressed the issue. But studies exploring the feasibility of the stoma closure under spinal/ regional anaesthesia are limited to a few case series. There is a dearth of good quality literature having a head to head comparison ileostomy closure done under spinal anaesthesia vs those done under the more commonly employed general anaesthesia. ERAS was brought into picture considering the physiological changes in metabolism during the perioperative period and implemented to cut short the phase of perioperative stress and early recovery of the patient, with minimal postoperative complications ERAS is an evidence based multidisciplinary approach that has outweighed many conventional approaches to achieve early discharge of the patient in various elective and emergency surgeries like Colorectal, Gastric, Hepatobiliary, Breast and Pre pyloric perforation Dr Henrik Kehlet, a Danish Colorectal Surgeon first proposed the concept of Fast track surgery in order to decrease the surgical stress, the different components being broadly classified into Preoperative, intra-operative and post-operative care. ERAS can potentially be implemented in Intestinal Stoma Reversal Surgery, and is worth demanding of a Day Care Surgery, with Spinal Anaesthesia expecting to be an adjunct in fastening the recovery.

Preoperative Preoperative counselling Avoid prolong fasting Carbohydrate loading No preanaesthetic medication Antibiotic prophylaxis Thromboprophylaxis

Intraoperative Short acting anaesthetics. Minimaly invasive surgery Goal directed fluid therapy Temperature homeostasis

Postoperative Prevention of PONV Early removal of catheter and drain. Early enteral nutrition Early mobilization

STUDY OBJECTIVES PRIMARY OBJECTIVE To study the return of bowel function Secondary Objective Return of functional parameters Complication rates Post operative pain assessment Surgeon and patient comfort

研究设计

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

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age of the patient ;18 years
  • Patients with Loop stoma, Double Barrel Stoma or End stoma with
  • documented hitched distal loop.
  • Patients evaluated and fit for surgery

排除标准

  • Patients requiring mid line laparotomy for stoma reversal
  • Patient having active stoma related complications like high output stoma
  • and dehydration - Acute Kidney Injury, stoma prolapse, etc making them
  • unfit for surgery.
  • Patient denying consent for SA or ERAS protocol
  • Patient having contraindication for either type of anaesthesia (where
  • randomisation would not be possible)
  • Patient needing to be converted to GA after pain /discomfort experienced
  • by patient or if there was failed spinal anaesthesia
  • Patient having abnormal coagulation profile
  • Coexistent neurological or psychiatric illness or unable to understand the

结局指标

主要结局

Time to passage of flatus

时间窗: Up to 72 hours after surgery

Time to passage of first flatus from the time of patient leaving operating room up to 72 hours after surgery will be estimated in hours

次要结局

  • Time to passage of motions(Up to 1 week after surgery)
  • Time of complete stoppage of IV fluids(Up to 72 hours after surgery)
  • Time taken to resumption of oral intake(Up to 72 hours after surgery)

研究者

发起方
All India Institute of Medical Sciences, Bhubaneswar
申办方类型
Other
责任方
Principal Investigator
主要研究者

Tushar Subhadarshan Mishra

Professor

All India Institute of Medical Sciences, Bhubaneswar

研究点 (2)

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