NCT04194060

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2019

Completed
19 days until next milestone

First Posted

Study publicly available on registry

December 11, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

January 20, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2021

Completed
Last Updated

March 18, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

November 22, 2019

Last Update Submit

March 16, 2022

Conditions

Peptic Ulcer PerforationPerforated BowelPost-Op ComplicationEmergenciesPerioperative Complication

Keywords

ERASEmergency surgeryFast track surgeryPerioperative CareEnhanced recovery after surgery

Outcome Measures

Primary Outcomes (1)

  • Length of hospital stay

    Duration from the time of operation to time of discharge

    Post operative period up-to one month.

Secondary Outcomes (2)

  • Recovery of functional parameters

    Post operative period up-to one month.

  • Post operative complications

    Post operative period up-to three months.

Other Outcomes (3)

  • Quality of life scoring and assessment

    Post operative period - at day of discharge, at one month follow up and at third month follow up.

  • Intra-abdominal collection

    Post operative period-at one month and at third month in post operative period.

  • Hematological parameter

    Post-operative period up-at one month and at third month.

Study Arms (2)

Enhanced recovery after surgery group

EXPERIMENTAL

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

Conventional group

ACTIVE COMPARATOR

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

Interventions

Enhanced Recovery after Surgery groupCOMBINATION_PRODUCT

* 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.

Enhanced recovery after surgery group
ConventionalCOMBINATION_PRODUCT

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.

Conventional group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tushar S Mishra

Bhubaneswar, Odisha, 751019, India

Location

Related Publications (4)

  • 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.

    PMID: 28653239BACKGROUND

  • 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.

    PMID: 30842811BACKGROUND

  • 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.

    PMID: 27509704BACKGROUND

  • 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.

    PMID: 24119887RESULT

MeSH Terms

Conditions

Peptic Ulcer PerforationIntestinal PerforationPostoperative ComplicationsEmergencies

Interventions

Congresses as Topic

Condition Hierarchy (Ancestors)

Peptic UlcerDuodenal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesStomach DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsDisease Attributes

Intervention Hierarchy (Ancestors)

OrganizationsHealth Care Economics and Organizations

Study Officials

  • TUSHAR S MISHRA, MBBS,MS

    All India Institute of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Patient will be allocated into two arms, ERAS(Enhanced recovery after surgery) group and Conventional group. 30 patients will be recruited in each arm.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Additional Professor

Study Record Dates

First Submitted

November 22, 2019

First Posted

December 11, 2019

Study Start

January 20, 2020

Primary Completion

May 15, 2021

Study Completion

June 15, 2021

Last Updated

March 18, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)