ERAS vs Conventional Approach in Peptic Perforation-RCT

Not Applicable

Completed

• Conditions: Perforated Bowel; Post-Op Complication; Peptic Ulcer Perforation; Perioperative Complication; Emergencies

• Registration Number: NCT04194060
• Lead Sponsor: All India Institute of Medical Sciences, Bhubaneswar

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-11-22
• Study First Submitted QC: 2019-12-07
• Study First Posted: 2019-12-11
• Study Start: 2020-01-20
• Primary Completion: 2021-05-15
• Study Completion: 2021-06-15
• Status Verified: 2022-03
• Last Update Submitted: 2022-03-16
• Last Update Posted: 2022-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Patient diagnosed with peptic perforation intra -operatively
2. Perforation of size <=1 cm
3. Patient age more than 18 years
4. American Society of Anesthesiologists score of I or II

Exclusion Criteria

1. Refractory septic shock at presentation.

2. Known Chronic kidney disease/ Chronic liver disease patients

3. Pregnant patients.

4. Patients with history of chronic steroid abuse.

5. Intraoperatively

   • Patient with coexistent peptic perforation with bleeding ulcer.
   • Peptic perforation requiring procedure other than Omental patch repair.
   • Sealed perforations.
   • Malignant perforation.

6. Patient requiring Positive Pressure Ventilator support post operatively for more than 12 hours.

7. Patient requiring urinary catheterization for other indications.

8. Coexistent neurological or psychiatric illness or unable to understand the study.

9. Patient refusing for consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Length of hospital stay	Post operative period up-to one month.	Duration from the time of operation to time of discharge

Secondary Outcome Measures

Name	Time	Method
Recovery of functional parameters	Post operative period up-to one month.	* 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 complications	Post operative period up-to three months.	* 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

Trial Locations

Locations (1)

Tushar S Mishra; 🇮🇳 Bhubaneswar, Odisha, India