ERAS vs Conventional Approach in Peptic Perforation-RCT

Study Overview
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Brief Summary
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This study compares 2 different ways of perioperative management in patients of peptic perforation. Experimental arm is the ERAS arm( Enhanced recovery after surgery) and the comparative arm is Conventional arm.

Detailed Description
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While the conventional approach to perioperative management can potentially prolong the post operative hospital stay, ERAS(Enhanced recovery after surgery), a multi-modal and multispeciality approach to perioperative management may reduce the length of hospital stay. In the preoperative period, patients will be counselled regarding the operative procedure and particulars of the perioperative management.In the intra-operative period short acting general anesthetic agents and short acting muscle relaxants will be used.Intravenous fluid administration will be goal directed. After the operative procedure, bilateral rectus sheath block will be administered. Patient will also receive post-operative nausea and vomiting prophylaxis. Nasogastric tube will be removed immediately after the operative procedure. In the post operative period, patients will be encouraged to ambulate early. Enteral nutrition will be initiated as early as possible. Indwelling catheters will be removed in the early post-operative procedure.

Official Title
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Enhanced Recovery After Surgery Versus Conventional Approach in Peptic Perforation-A Randomized Control Trial

Conditions
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Peptic Ulcer Perforation, Perforated Bowel, Post-Op Complication, Emergencies, Perioperative Complication

Intervention / Treatment
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* Combination Product: Enhanced Recovery after Surgery group
* Combination Product: Conventional


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient diagnosed with peptic perforation intra -operatively Perforation of size <=1 cm Patient age more than 18 years American Society of Anesthesiologists score of I or II Exclusion Criteria: Refractory septic shock at presentation. Known Chronic kidney disease/ Chronic liver disease patients Pregnant patients. Patients with history of chronic steroid abuse. Intraoperatively Patient with coexistent peptic perforation with bleeding ulcer. Peptic perforation requiring procedure other than Omental patch repair. Sealed perforations. Malignant perforation. Patient requiring Positive Pressure Ventilator support post operatively for more than 12 hours. Patient requiring urinary catheterization for other indications. Coexistent neurological or psychiatric illness or unable to understand the study. Patient refusing for consent.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patient will be allocated into two arms, ERAS(Enhanced recovery after surgery) group and Conventional group. 30 patients will be recruited in each arm.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Enhanced recovery after surgery group<br>ERAS GROUP Tracheal intubation. Short acting anesthetic agents,avoid opioid agents Omental patch repair with placement of sub hepatic drain Bilateral Transverse abdominis plane block/ Rectus sheath block immediately after surgery. Post operative nausea and vomiting prophylaxis. Encourage to mobilize out of bed after effect of general anesthesia has weaned off. Initiation of feeding-Oral sips on day 1, step up day 2 onward Removal of nasogastric tube-immediately after surgery after aspirating the gastric content through nasogastric tube. Removal of urinary catheter-after weaning from the effect of general anesthesia. Sub hepatic drain removal -anytime within 24 hours;drain will not be removed if fluid is bilious or pus. Avoid opiod analgesics. | Combination Product: Enhanced Recovery after Surgery group<br>* Tracheal intubation and with General anesthesia Short acting anesthetic agents,avoid opioid agents Omental patch repair with placement of sub hepatic drain Bilateral Transverse abdominis plane block/ Rectus sheath block immediately after surgery. Post operative nausea and vomiting prophylaxis. Encourage to mobilize out of bed after effect of general anesthesia has weaned off. Initiation of feeding-Oral sips on day 1, step up day 2 onward Removal of nasogastric tube-immediately after surgery after aspirating the gastric content through nasogastric tube. Removal of urinary catheter-after weaning from the effect of general anesthesia. Sub hepatic drain removal -anytime within 24 hours;drain will not be removed if fluid is bilious or pus. Avoid opiod analgesics.<br>|
| Active Comparator: Conventional group<br>CONVENTIONAL GROUP Tracheal intubation Short acting anesthetic agents, avoid opiod anesthesia agents. Omental patch repair along with sub hepatic drain placement. Post operative nausea and vomiting prophylaxis. Ambulation-as per patients' own request. Initiation of oral feed- after passage of 1st flatus. Nasogastric tube removal-output <300ml/day with resolution of ileus. Removal of urinary catheter- when patient sits on bed side/ambulate. Removal of sub hepatic drain-when patient tolerates unrestricted amount of liquid diet and drain output is less than 200 ml /day. Patient will receive opiod analgesics. I | Combination Product: Conventional<br>* Tracheal intubation Short acting anesthetic agents, avoid opiod anesthesia agents. Omental patch repair along with sub hepatic drain placement. Post operative nausea and vomiting prophylaxis. Ambulation-as per patients' own request. Initiation of oral feed- after passage of 1st flatus. Nasogastric tube removal-output <300ml/day with resolution of ileus. Removal of urinary catheter- when patient sits on bed side/ambulate. Removal of sub hepatic drain-when patient tolerates unrestricted amount of liquid diet and drain output is less than 200 ml /day. Patient will receive opiod analgesics.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Duration from the time of operation to time of discharge | Post operative period up-to one month. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of functional parameters | Time of withdrawal of nasogastric tube (hours) Time to first bowel sound (hours) Time to first flatus (hours) Time to first stool (hours) Time to removal of drain(hours) Time to first fluid diet (hours) Time to first solid diet (hours) Time to stoppage of IV fluids(hours) Time of removal of urinary catheter (hours) Time to ambulation(hours) | Post operative period up-to one month. | 
| Post operative complications | Anastomotic leakage Pneumonia Ileus Obstruction Wound infection Abdominal sepsis Burst Abdomen Need for reinsertion of nasogastric tube Need for reinsertion of urinary catheter Need for drainage of abdominal collection Readmission Re operation Mortality | Post operative period up-to three months. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ERAS, Emergency surgery, Fast track surgery, Perioperative Care, Enhanced recovery after surgery