Back to resultsERAS vs Conventional Approach in Peptic Perforation-RCT (ERASE)
Primary Purpose
Peptic Ulcer Perforation, Perforated Bowel, Post-Op Complication
Status
Completed
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Enhanced Recovery after Surgery group
Conventional
Sponsored by
About this trial
This is an interventional supportive care trial for Peptic Ulcer Perforation focused on measuring ERAS, Emergency surgery, Fast track surgery, Perioperative Care, Enhanced recovery after surgery
Eligibility Criteria
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.
Sites / Locations
- Tushar S Mishra
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Enhanced recovery after surgery group
Conventional group
Arm Description
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.
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
Outcomes
Primary Outcome Measures
Length of hospital stay
Duration from the time of operation to time of discharge
Secondary Outcome Measures
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 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
Full Information
NCT ID
NCT04194060
First Posted
November 22, 2019
Last Updated
March 16, 2022
Sponsor
All India Institute of Medical Sciences, Bhubaneswar
1. Study Identification
Unique Protocol Identification Number
NCT04194060
Brief Title
ERAS vs Conventional Approach in Peptic Perforation-RCT
Acronym
ERASE
Official Title
Enhanced Recovery After Surgery Versus Conventional Approach in Peptic Perforation-A Randomized Control Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
January 20, 2020 (Actual)
Primary Completion Date
May 15, 2021 (Actual)
Study Completion Date
June 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
All India Institute of Medical Sciences, Bhubaneswar
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peptic Ulcer Perforation, Perforated Bowel, Post-Op Complication, Emergencies, Perioperative Complication
Keywords
ERAS, Emergency surgery, Fast track surgery, Perioperative Care, Enhanced recovery after surgery
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Enhanced recovery after surgery group
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional group
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Combination Product
Intervention Name(s)
Enhanced Recovery after Surgery group
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
Conventional
Intervention Description
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.
Primary Outcome Measure Information:
Title
Length of hospital stay
Description
Duration from the time of operation to time of discharge
Time Frame
Post operative period up-to one month.
Secondary Outcome Measure Information:
Title
Recovery of functional parameters
Description
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)
Time Frame
Post operative period up-to one month.
Title
Post operative complications
Description
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
Time Frame
Post operative period up-to three months.
Other Pre-specified Outcome Measures:
Title
Quality of life scoring and assessment
Description
Quality of life assessment will be done using EQ-5D-5L questionnaire (Euroqol 5 dimensions and 5 levels). It has 2 components, descriptive and objective. Descriptive component comprises of 5 dimensions which are mobility, self care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels, namely no problem, slight problems, moderate problems, severe problems and extreme problems. Objective component is also called Euroqol visual analog scale. Score ranges from zero to hundred.The endpoints are labelled as 'the best health participant can imagine' and 'the worst health participant can imagine'. It will be assessed on the day of discharge, follow up at one month and follow up at third month in the post operative period.
Time Frame
Post operative period - at day of discharge, at one month follow up and at third month follow up.
Title
Intra-abdominal collection
Description
Ultrasonography abdomen will be done at one month to look for any intra-abdominal collection and if any collection is found, will be repeated at third month follow up.
Time Frame
Post operative period-at one month and at third month in post operative period.
Title
Hematological parameter
Description
Total leukocyte count will be measured at follow up at one month.If the value is more than 11,000 cells/mm cube or less than 4000 cells/mm cube, then it will be measured again at third month of follow up.
Time Frame
Post-operative period up-at one month and at third month.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
TUSHAR S MISHRA, MBBS,MS
Organizational Affiliation
All India Institute of Medical Sciences, New Delhi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tushar S Mishra
City
Bhubaneswar
State/Province
Odisha
ZIP/Postal Code
751019
Country
India
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
28653239
Citation
Mohsina S, Shanmugam D, Sureshkumar S, Kundra P, Mahalakshmy T, Kate V. Adapted ERAS Pathway vs. Standard Care in Patients with Perforated Duodenal Ulcer-a Randomized Controlled Trial. J Gastrointest Surg. 2018 Jan;22(1):107-116. doi: 10.1007/s11605-017-3474-2. Epub 2017 Jun 26.
Results Reference
background
PubMed Identifier
30842811
Citation
Lohsiriwat V, Jitmungngan R. Enhanced recovery after surgery in emergency colorectal surgery: Review of literature and current practices. World J Gastrointest Surg. 2019 Feb 27;11(2):41-52. doi: 10.4240/wjgs.v11.i2.41.
Results Reference
background
PubMed Identifier
27509704
Citation
Agarwal A, Jain S, Meena LN, Jain SA, Agarwal L. Validation of Boey's score in predicting morbidity and mortality in peptic perforation peritonitis in Northwestern India. Trop Gastroenterol. 2015 Oct-Dec;36(4):256-60. doi: 10.7869/tg.300.
Results Reference
background
PubMed Identifier
24119887
Citation
Gonenc M, Dural AC, Celik F, Akarsu C, Kocatas A, Kalayci MU, Dogan Y, Alis H. Enhanced postoperative recovery pathways in emergency surgery: a randomised controlled clinical trial. Am J Surg. 2014 Jun;207(6):807-14. doi: 10.1016/j.amjsurg.2013.07.025. Epub 2013 Oct 10.
Results Reference
result
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ERAS vs Conventional Approach in Peptic Perforation-RCT
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