<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04431037</url>
  </required_header>
  <id_info>
    <org_study_id>pdu</org_study_id>
    <nct_id>NCT04431037</nct_id>
  </id_info>
  <brief_title>Early Oral Feeding vs Traditional Post-operative Care In Emergency Abdominal Surgeries</brief_title>
  <official_title>EARLY ORAL FEEDING VS TRADITIONAL POST-OPERATIVE CARE IN PATIENTS UNDERGOING EMERGENCY ABDOMINAL SURGERY FOR PERFORATED DUODENAL ULCER(Emergency Abdominal Surgeries)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>College of Physicians and Surgeons Pakistan</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>College of Physicians and Surgeons Pakistan</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      ABSTRACT BACKGROUND: Enhanced recovery after surgery (ERAS) protocols have been widely&#xD;
      studied in elective abdominal surgeries and have shown better outcomes. However the utility&#xD;
      of these protocols in emergency abdominal surgeries has not been widely investigated.&#xD;
&#xD;
      OBJECTIVE: To study the outcomes of application of ERAS protocols in patients undergoing&#xD;
      perforated duodenal ulcers repairs in emergency abdominal surgeries.&#xD;
&#xD;
      METHODS: This randomized controlled trial was conducted in Surgical Unit 1 BBH from August&#xD;
      2018 to December 2019 with a total sample size of 36 patients with the diagnosis of&#xD;
      perforated duodenal ulcer. Patients were randomly divided in two groups. Group A consisted of&#xD;
      early oral feeding group and group B consisted of traditional postoperative care group.&#xD;
      Outcome results studied were the length of hospital stay, duodenal repair site leak, severity&#xD;
      of pain (VAS score) and duration of post-operative ileus. Results were analysed on SPSS&#xD;
      version 20 and chi-square and independent t-test were applied.&#xD;
&#xD;
      KEY WORDS: Perforated duodenal ulcer, ERAS protocol, randomized controlled trial, duodenal&#xD;
      repair site leak, length of hospital stay, VAS score, post-operative ileus&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 13, 2018</start_date>
  <completion_date type="Actual">December 27, 2019</completion_date>
  <primary_completion_date type="Actual">October 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_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.</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
    <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.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>upto 10 Days</time_frame>
    <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</description>
  </primary_outcome>
  <primary_outcome>
    <measure>DAYS OF RETURN OF BOWEL FUNCTION.</measure>
    <time_frame>Upto 24 hours</time_frame>
    <description>It is defined as time to passage of flatus or stools after abdominal surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain score by Visual Analog Scale</measure>
    <time_frame>upto 36 hours</time_frame>
    <description>Pain is defined as &quot;an unpleasant sensory and emotional experience that is associated with actual or potential tissue damage or described in such terms&quot; according to International Association for the Study of Pain,measured by Visual Analog Scale(VAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bleeding peptic ulcer</measure>
    <time_frame>intraoperative period</time_frame>
    <description>Frequency of bleeding peptic ulcer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality rate</measure>
    <time_frame>immediate postoperative period</time_frame>
    <description>Estimation of mortality rate associated with perforated duodenal ulcer</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Gender distribution</measure>
    <time_frame>Perioperative period</time_frame>
    <description>To assess the frequency of perforated duodenal ulcer according to gender</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Perforated Duodenal Ulcer</condition>
  <arm_group>
    <arm_group_label>Early oral feeding group(A)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional postoperative care group(B)</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group were managed traditionally</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>Early oral feeding/Enhanced recovery after surgery protocols</intervention_name>
    <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.</description>
    <arm_group_label>Early oral feeding group(A)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients older than 15 years with acute abdominal symptoms admitted in ER&#xD;
             department, suspected as perforated duodenal ulcer and operated within 24 hours of&#xD;
             admission by emergency department surgeon.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients presenting with the following criteria were excluded:&#xD;
&#xD;
          -  Refusal to join the study&#xD;
&#xD;
          -  Peptic ulcers with both bleeding and perforation.&#xD;
&#xD;
          -  Spontaneously sealed off perforations.&#xD;
&#xD;
          -  Malignant ulcers&#xD;
&#xD;
          -  Concurrent extra-abdominal surgery&#xD;
&#xD;
          -  Oral incapacity i.e endotracheal intubation&#xD;
&#xD;
          -  Reoperation within a month&#xD;
&#xD;
          -  ASA grade III/IV&#xD;
&#xD;
          -  Alternative per operative diagnosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Surgical Unit I,Benazir Bhutto Hospital</name>
      <address>
        <city>Rawalpindi</city>
        <state>Punjab</state>
        <zip>46000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 12, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>June 12, 2020</last_update_submitted>
  <last_update_submitted_qc>June 12, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>College of Physicians and Surgeons Pakistan</investigator_affiliation>
    <investigator_full_name>Ayesha Masood</investigator_full_name>
    <investigator_title>Postgraduate trainee, General Surgery</investigator_title>
  </responsible_party>
  <keyword>Perforated duodenal ulcer</keyword>
  <keyword>Enhanced Recovery After Surgery (ERAS) protocol</keyword>
  <keyword>Randomized controlled trial</keyword>
  <keyword>Duodenal repair site leak</keyword>
  <keyword>Length of hospital stay</keyword>
  <keyword>Visual analog score</keyword>
  <keyword>Post-operative ileus</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Duodenal Ulcer</mesh_term>
    <mesh_term>Emergencies</mesh_term>
    <mesh_term>Ulcer</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Data can be shared on request.Only that described in the text of full article.</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 10, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/37/NCT04431037/Prot_SAP_ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04431037
org study id: pdu
nct id: NCT04431037
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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
allocation: Randomized
intervention model: Parallel Assignment
intervention 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.
primary purpose: Other
masking: Double (Participant, Investigator)
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.
measure: Length of hospital stay
time frame: upto 10 Days
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
measure: DAYS OF RETURN OF BOWEL FUNCTION.
time frame: Upto 24 hours
description: It is defined as time to passage of flatus or stools after abdominal surgery.
measure: Pain score by Visual Analog Scale
time frame: upto 36 hours
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).
measure: Bleeding peptic ulcer
time frame: intraoperative period
description: Frequency of bleeding peptic ulcer
measure: Mortality rate
time frame: immediate postoperative period
description: Estimation of mortality rate associated with perforated duodenal ulcer
measure: Gender distribution
time frame: Perioperative period
description: To assess the frequency of perforated duodenal ulcer according to gender
arm group label: Early oral feeding group(A)
arm group type: Experimental
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 group label: Traditional postoperative care group(B)
arm group type: No Intervention
description: Patients in this group were managed traditionally
intervention type: Dietary Supplement
intervention name: Early oral feeding/Enhanced recovery after surgery protocols
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.
arm group label: Early oral feeding group(A)
criteria: 
gender: All
minimum age: 15 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Pakistan
responsible party type: Principal Investigator
investigator affiliation: College of Physicians and Surgeons Pakistan
investigator full name: Ayesha Masood
investigator title: Postgraduate trainee, General Surgery
mesh term: Duodenal Ulcer
mesh term: Emergencies
mesh term: Ulcer
sharing ipd: No
ipd description: Data can be shared on request.Only that described in the text of full article.
provided document: 