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

Perforated Duodenal Ulcer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04431037
• Other study ID #: pdu
• Status: Completed
• Phase: N/A
• Start date: August 13, 2018
• Est. completion date: December 27, 2019

Study information

• Verified date: June 2020
• Source: College of Physicians and Surgeons Pakistan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 27, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Duodenal Ulcer
• Emergencies
• Perforated Duodenal Ulcer
• Ulcer

Intervention

Dietary Supplement:
• Early 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.

Locations

Country	Name	City	State
Pakistan	Surgical Unit I,Benazir Bhutto Hospital	Rawalpindi	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
College of Physicians and Surgeons Pakistan

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Gender distribution	To assess the frequency of perforated duodenal ulcer according to gender	Perioperative period
Primary	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
Primary	DAYS OF RETURN OF BOWEL FUNCTION.	It is defined as time to passage of flatus or stools after abdominal surgery.	Upto 24 hours
Primary	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	Bleeding peptic ulcer	Frequency of bleeding peptic ulcer	intraoperative period
Secondary	Mortality rate	Estimation of mortality rate associated with perforated duodenal ulcer	immediate postoperative period