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

Not Applicable
Completed
Conditions
Perforated Duodenal Ulcer
Interventions
Dietary Supplement: Early oral feeding/Enhanced recovery after surgery protocols
Registration Number
NCT04431037
Lead Sponsor
College of Physicians and Surgeons Pakistan
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
36
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 & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Early oral feeding group(A)Early oral feeding/Enhanced recovery after surgery protocolsPatients 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.
Primary Outcome Measures
NameTimeMethod
Length of hospital stayupto 10 Days

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

DAYS OF RETURN OF BOWEL FUNCTION.Upto 24 hours

It is defined as time to passage of flatus or stools after abdominal surgery.

Pain score by Visual Analog Scaleupto 36 hours

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).

Secondary Outcome Measures
NameTimeMethod
Mortality rateimmediate postoperative period

Estimation of mortality rate associated with perforated duodenal ulcer

Bleeding peptic ulcerintraoperative period

Frequency of bleeding peptic ulcer

Trial Locations

Locations (1)

Surgical Unit I,Benazir Bhutto Hospital

🇵🇰

Rawalpindi, Punjab, Pakistan

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