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

Study Overview
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Brief Summary
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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

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

Conditions
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Perforated Duodenal Ulcer

Intervention / Treatment
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* Dietary Supplement: Early oral feeding/Enhanced recovery after surgery protocols


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early oral feeding group(A)<br>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<br>* 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.<br>|
| No Intervention: Traditional postoperative care group(B)<br>Patients in this group were managed traditionally | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Perforated duodenal ulcer, Enhanced Recovery After Surgery (ERAS) protocol, Randomized controlled trial, Duodenal repair site leak, Length of hospital stay, Visual analog score, Post-operative ileus