Clinical trial NCT04431037: Early Oral Feeding vs Traditional Post-operative Care In Emergency Abdominal Surgeries
Official title: EARLY ORAL FEEDING VS TRADITIONAL POST-OPERATIVE CARE IN PATIENTS UNDERGOING EMERGENCY ABDOMINAL SURGERY FOR PERFORATED DUODENAL ULCER(Emergency Abdominal Surgeries)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Perforated Duodenal Ulcer
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
Lead sponsor: College of Physicians and Surgeons Pakistan
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 36
Sex: ALL
Minimum age (years): 15
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: OTHER

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


Eligibility criteria: 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.

Primary outcomes:
measure: Length of hospital stay
timeFrame: upto 10 Days
measure: DAYS OF RETURN OF BOWEL FUNCTION.
timeFrame: Upto 24 hours
measure: Pain score by Visual Analog Scale
timeFrame: upto 36 hours
Secondary outcomes:
measure: Bleeding peptic ulcer
timeFrame: intraoperative period
measure: Mortality rate
timeFrame: immediate postoperative period
Other outcomes:
measure: Gender distribution
timeFrame: Perioperative period
Locations:
city: Rawalpindi
country: Pakistan
facility: Surgical Unit I,Benazir Bhutto Hospital
state: Punjab
Study officials:
References: