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

Not Applicable

Completed

• Conditions: Perforated Duodenal Ulcer

• 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

Study Timeline

• Study Start: 2018-08-13
• Primary Completion: 2019-10-30
• Study Completion: 2019-12-27
• Status Verified: 2020-06
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-12
• Last Update Submitted: 2020-06-12
• Study First Posted: 2020-06-16
• Last Update Posted: 2020-06-16

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Bleeding peptic ulcer	intraoperative period	Frequency of bleeding peptic ulcer
Mortality rate	immediate postoperative period	Estimation of mortality rate associated with perforated duodenal ulcer

Trial Locations

Locations (1)

Surgical Unit I,Benazir Bhutto Hospital; 🇵🇰 Rawalpindi, Punjab, Pakistan