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Completed

NCT Number: NCT04431037

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

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

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Key information

Conditions

Perforated Duodenal Ulcer

Age range

15 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Surgical Unit I,Benazir Bhutto Hospital

Rawalpindi, Punjab Province, 46000, Pakistan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Length of hospital stay

    Time frame: 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

  2. DAYS OF RETURN OF BOWEL FUNCTION.

    Time frame: Upto 24 hours

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

  3. Pain score by Visual Analog Scale

    Time frame: 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 outcomes

  1. Bleeding peptic ulcer

    Time frame: intraoperative period

    Frequency of bleeding peptic ulcer

  2. Mortality rate

    Time frame: immediate postoperative period

    Estimation of mortality rate associated with perforated duodenal ulcer

Other outcomes

  1. Gender distribution

    Time frame: Perioperative period

    To assess the frequency of perforated duodenal ulcer according to gender

Sponsors and collaborators

Lead sponsor

College of Physicians and Surgeons Pakistan

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jun 16, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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