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

Primary Purpose

Perforated Duodenal Ulcer

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Early oral feeding/Enhanced recovery after surgery protocols
Sponsored by
College of Physicians and Surgeons Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Perforated Duodenal Ulcer focused on measuring 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

Eligibility Criteria

15 Years - 80 Years (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Surgical Unit I,Benazir Bhutto Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Early oral feeding group(A)

Traditional postoperative care group(B)

Arm Description

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.

Patients in this group were managed traditionally

Outcomes

Primary Outcome Measures

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
DAYS OF RETURN OF BOWEL FUNCTION.
It is defined as time to passage of flatus or stools after abdominal surgery.
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).

Secondary Outcome Measures

Bleeding peptic ulcer
Frequency of bleeding peptic ulcer
Mortality rate
Estimation of mortality rate associated with perforated duodenal ulcer

Full Information

First Posted
June 3, 2020
Last Updated
June 12, 2020
Sponsor
College of Physicians and Surgeons Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT04431037
Brief Title
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

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
December 27, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
College of Physicians and Surgeons Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantInvestigator
Masking Description
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.
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Early oral feeding group(A)
Arm Type
Experimental
Arm Description
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.
Arm Title
Traditional postoperative care group(B)
Arm Type
No Intervention
Arm Description
Patients in this group were managed traditionally
Intervention Type
Dietary Supplement
Intervention Name(s)
Early oral feeding/Enhanced recovery after surgery protocols
Intervention Description
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 Outcome Measure Information:
Title
Length of hospital stay
Description
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
Time Frame
upto 10 Days
Title
DAYS OF RETURN OF BOWEL FUNCTION.
Description
It is defined as time to passage of flatus or stools after abdominal surgery.
Time Frame
Upto 24 hours
Title
Pain score by Visual Analog Scale
Description
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).
Time Frame
upto 36 hours
Secondary Outcome Measure Information:
Title
Bleeding peptic ulcer
Description
Frequency of bleeding peptic ulcer
Time Frame
intraoperative period
Title
Mortality rate
Description
Estimation of mortality rate associated with perforated duodenal ulcer
Time Frame
immediate postoperative period
Other Pre-specified Outcome Measures:
Title
Gender distribution
Description
To assess the frequency of perforated duodenal ulcer according to gender
Time Frame
Perioperative period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Surgical Unit I,Benazir Bhutto Hospital
City
Rawalpindi
State/Province
Punjab
ZIP/Postal Code
46000
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Data can be shared on request.Only that described in the text of full article.

Learn more about this trial

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

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