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

NCT04431037 | Completed

• 1 other identifier: pdu
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (3)

• 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

• DAYS OF RETURN OF BOWEL FUNCTION.

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

  Upto 24 hours

• 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 Outcomes (2)

• Bleeding peptic ulcer

  intraoperative period

• Mortality rate

  immediate postoperative period

Other Outcomes (1)

• Gender distribution

  Perioperative period

Study Arms (2)

Early oral feeding group(A)

EXPERIMENTAL

Patients 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.

Dietary Supplement: Early oral feeding/Enhanced recovery after surgery protocols

Traditional postoperative care group(B)

NO INTERVENTION

Patients in this group were managed traditionally

Interventions

Early oral feeding/Enhanced recovery after surgery protocols DIETARY_SUPPLEMENT

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.

Early oral feeding group(A)

Eligibility Criteria

• Age: 15 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• College of Physicians and Surgeons Pakistan: lead

Study Sites (1)

Surgical Unit I,Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: 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.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Postgraduate trainee, General Surgery

Model Details: 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.

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 16, 2020
• Study Start: August 13, 2018
• Primary Completion: October 30, 2019
• Study Completion: December 27, 2019
• Last Updated: June 16, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)