Impact of Abdominal Drains on the Efficacy of ERAS Pathway in the Perioperative Management of Peptic Perforation - A Randomized Control Trail (TUBELESS TRAIL)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Length of hospital stay (in days)
研究概览
简要总结
This study plans to assess the effect of placement of abdominal drains on the outcomes of ERAS (Enhanced recovery after surgery) protocol in the perioperative management of peptic perforation. In the study arm ERAS protocol will be implemented avoiding use of abdominal drain. In the control arm abdominal drains will be placed in the early post operative period while using the ERAS protocol. The effect of drains on duration of post operative stay and other return to physiological parameter like onset of ambulation, oral intake, passing flatus and feces etc. will be studied. The investigators hypothesize that the non-placement of abdominal drain postoperatively will not have worse outcomes than in cases where it is used postoperatively, in terms of length of hospital stay.
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详细描述
ERAS is a an evidence based perioperative care pathways aiming reduction in the surgical stress. ERAS is a an evidence based perioperative care pathways aiming reduction in the surgical stress. Studies assessing the outcome of non usage to abdominal drains on the post-operative outcomes are scarce. This study aims to study the influence of abdominal drains on the post operative hospital stay and other functional outcomes.
Methods Patient with hollow viscus perforation to the emergency rooms and diagnosed to have peptic ulcer perforation intraoperatively will be included in the study. After omental patch repair and completion of operative procedure, patient will be randomized into drain group and no drain group based on the random allocation software.
Preoperative Early identification of physiological derangement and intervention. Early identification of physiological derangement and intervention. Early identification of physiological derangement and intervention. Early imaging , surgery and source control of sepsis. Risk assessment - PULP (Peptic Ulcers Perforation) score, Mannheim peritonitis index score, Boey score.
Intraoperatively Short acting anesthesia agents. warm normal saline lavage. Omental patch repair. Bilateral rectus sheath block. Bilateral rectus sheath block. Peritoneal fluid for culture and sensitivity. Mucosal edge / pinch biopsy to rule out any malignancy. Post operative nausea and vomiting (PONV) prophylaxis Balanced intravenous fluid administration. Post operatively Immobilization, Oral intake, Intravenous nutrition after study, Removal of nasogastric tube, Removal of catheter.
Intervention Abdominal drain group with ERAS protocol and no abdominal drain group with ERAS protocol.
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
- 否
入选标准
- •Patient of peptic ulcer perforation peritonitis ( when confirmed intraoperatively)
- •Perforation of size less than or equal to 1 cm.
- •Patient age more than 18 years age
- •American society of anesthesiologists score of I or II
排除标准
- •Refractory septic shock at presentation
- •Known Chronic kidney disease (CKD)/Chronic liver disease (CLD) patients
- •Deranged LFT, RFT or active respiratory illness pneumonia or COPD ( Spo2 below 94 on room air)
- •Pregnant patients
- •History of chronic steroid abuse
- •INTRAOPERATIVELY detected coexistent bleeding peptic ulcer, perforation requiring operation other than omental patch repair, spontaneously sealed peptic perforation, malignant perforation
- •Patient requiring positive pressure ventilatory support post-operatively for more than 6 hours.
- •Patient refusing consent.
- •Co-existent neurological or psychiatric illness or unable to understand the study
结局指标
主要结局
Length of hospital stay (in days)
时间窗: Post operative period up-to one month.
Duration from the time of operation to time of discharge
次要结局
- Early postoperative abdominal pain measured using the Verbal numeric scale (VNS)(At 8 hours, 24 hours and 72 hours postoperatively)
- Need for re-intervention in either arm(Up-to one month post operatively)
- Quality of life scoring and assessment(Post operative period - at 48 hours after surgery, at one month follow up and at third month follow up.)
- Incidence of Complications(Up-to one month post operatively)
- Time of recovery of Functional parameters (in hours)(Up to one month post operatively)
- Re-admission rates(Date of discharge to 1 month post operative period)
- Degree of compliance to the ERAS protocol(Up to the time of discharge)
研究者
Tushar Subhadarshan Mishra
Professor
All India Institute of Medical Sciences, Bhubaneswar