Clinical trial NCT04194060: ERAS vs Conventional Approach in Peptic Perforation-RCT
Official title: Enhanced Recovery After Surgery Versus Conventional Approach in Peptic Perforation-A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Peptic Ulcer Perforation
Perforated Bowel
Post-Op Complication
Emergencies
Perioperative Complication
Keywords: ERAS
Emergency surgery
Fast track surgery
Perioperative Care
Enhanced recovery after surgery
Lead sponsor: All India Institute of Medical Sciences, Bhubaneswar
Sponsor class: OTHER
First posted: 2019-12-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Length of hospital stay
timeFrame: Post operative period up-to one month.
Secondary outcomes:
measure: Recovery of functional parameters
timeFrame: Post operative period up-to one month.
measure: Post operative complications
timeFrame: Post operative period up-to three months.
Other outcomes:
measure: Quality of life scoring and assessment
timeFrame: Post operative period - at day of discharge, at one month follow up and at third month follow up.
measure: Intra-abdominal collection
timeFrame: Post operative period-at one month and at third month in post operative period.
measure: Hematological parameter
timeFrame: Post-operative period up-at one month and at third month.
Locations:
city: Bhubaneswar
country: India
facility: Tushar S Mishra
state: Odisha
Study officials:
affiliation: All India Institute of Medical Sciences
name: TUSHAR S MISHRA, MBBS,MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.