Perforated Duodenal Ulcer
Conditions
Keywords
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
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
Interventions
DIETARY_SUPPLEMENTEarly 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.
Sponsors
College of Physicians and Surgeons Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Masking description
Patients admitted in the emergency department were randomly assigned into treatment group or control group in postoperative period.Neither the researcher nor the patient were aware of the patient allocation.Patients were management by the oncall surgical team irrespective of the researcher.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
15 Years to 80 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of hospital stay | upto 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 Scale | upto 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
| Measure | Time frame | Description |
|---|---|---|
| Bleeding peptic ulcer | intraoperative period | Frequency of bleeding peptic ulcer |
| Mortality rate | immediate postoperative period | Estimation of mortality rate associated with perforated duodenal ulcer |
Other
| Measure | Time frame | Description |
|---|---|---|
| Gender distribution | Perioperative period | To assess the frequency of perforated duodenal ulcer according to gender |
Countries
Pakistan
Outcome results
None listed