Early Oral Feeding vs Traditional Post-operative Care In Emergency Abdominal Surgeries

EARLY ORAL FEEDING VS TRADITIONAL POST-OPERATIVE CARE IN PATIENTS UNDERGOING EMERGENCY ABDOMINAL SURGERY FOR PERFORATED DUODENAL ULCER(Emergency Abdominal Surgeries)

ABSTRACT BACKGROUND: Enhanced recovery after surgery (ERAS) protocols have been widely studied in elective abdominal surgeries and have shown better outcomes. However the utility of these protocols in emergency abdominal surgeries has not been widely investigated.

OBJECTIVE: To study the outcomes of application of ERAS protocols in patients undergoing perforated duodenal ulcers repairs in emergency abdominal surgeries.

METHODS: This randomized controlled trial was conducted in Surgical Unit 1 BBH from August 2018 to December 2019 with a total sample size of 36 patients with the diagnosis of perforated duodenal ulcer. Patients were randomly divided in two groups. Group A consisted of early oral feeding group and group B consisted of traditional postoperative care group. Outcome results studied were the length of hospital stay, duodenal repair site leak, severity of pain (VAS score) and duration of post-operative ileus. Results were analysed on SPSS version 20 and chi-square and independent t-test were applied.

KEY WORDS: Perforated duodenal ulcer, ERAS protocol, randomized controlled trial, duodenal repair site leak, length of hospital stay, VAS score, post-operative ileus

Study Overview

• Status: Completed
• Conditions: Perforated Duodenal Ulcer
• Intervention / Treatment: Dietary supplement: Early oral feeding/Enhanced recovery after surgery protocols

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Rawalpindi, Punjab, Pakistan, 46000
      • Surgical Unit I,Benazir Bhutto Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 78 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• All patients older than 15 years with acute abdominal symptoms admitted in ER department, suspected as perforated duodenal ulcer and operated within 24 hours of admission by emergency department surgeon.

Exclusion Criteria:

• Patients presenting with the following criteria were excluded:
• Refusal to join the study
• Peptic ulcers with both bleeding and perforation.
• Spontaneously sealed off perforations.
• Malignant ulcers
• Concurrent extra-abdominal surgery
• Oral incapacity i.e endotracheal intubation
• Reoperation within a month
• ASA grade III/IV
• Alternative per operative diagnosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Early oral feeding group(A); Patients admitted in the HDU postoperatively.NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD.	Dietary supplement: Early oral feeding/Enhanced recovery after surgery protocols; Early oral feeding refers to NG tube and foley's catheter removed within 12 hours and patients allowed oral sips on day 1 with gradual shift to liquid diet after 12 hrs and semisolid food started after 24 hours later.Patients were given i/v antibiotics,painkillers and i/v PPIs and shifted to oral pain killers on 2nd POD.
No Intervention: Traditional postoperative care group(B); Patients in this group were managed traditionally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay is defined as duration of single episode of hospitalization. Inpatient days are calculated by subtracting day of admission from day of discharge	upto 10 Days
DAYS OF RETURN OF BOWEL FUNCTION.	It is defined as time to passage of flatus or stools after abdominal surgery.	Upto 24 hours
Pain score by Visual Analog Scale	Pain is defined as "an unpleasant sensory and emotional experience that is associated with actual or potential tissue damage or described in such terms" according to International Association for the Study of Pain,measured by Visual Analog Scale(VAS).	upto 36 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bleeding peptic ulcer	Frequency of bleeding peptic ulcer	intraoperative period
Mortality rate	Estimation of mortality rate associated with perforated duodenal ulcer	immediate postoperative period

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gender distribution	To assess the frequency of perforated duodenal ulcer according to gender	Perioperative period

Collaborators and Investigators

• Sponsor: College of Physicians and Surgeons Pakistan

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2018
• Primary Completion (Actual): October 30, 2019
• Study Completion (Actual): December 27, 2019

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 12, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): June 16, 2020
• Last Update Submitted That Met QC Criteria: June 12, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Length of hospital stay; Perforated duodenal ulcer; Enhanced Recovery After Surgery (ERAS) protocol; Duodenal repair site leak; Visual analog score; Post-operative ileus
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Stomach Diseases; Intestinal Diseases; Peptic Ulcer; Duodenal Diseases; Ulcer; Emergencies; Duodenal Ulcer
• Other Study ID Numbers: pdu

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Data can be shared on request.Only that described in the text of full article.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No