Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04584060
Collaborator
(none)
60
14.9

Study Details

Study Description

Brief Summary

Although the ERAS program is widely used in elective procedures in many surgical subspecialties, the place of this program in emergency surgery remains uncertain probably because of the significant challenges in applying all ERAS pathways in the emergency setting. Nevertheless, the ERAS program is often modified in elective procedures on an individual and/ or institutional basis and thus may also have a role in the emergency setting albeit in a modified form.

Condition or Disease Intervention/Treatment Phase
  • Combination Product: ERAS protocols
  • Combination Product: Early oral feeding
  • Combination Product: Prophylaxis against DVT

Detailed Description

The cases will be randomized simply into two groups, Group (A) for conventional care and Group (B) for ERAS. Random assignment of intervention will be done after subjects have been assessed for eligibility and recruited. The sealed envelope method will be used for randomization.

Both groups will have pre-operative ryle inserted, urinary catheter applied, Tracheal intubation and with General anesthesia, exploration laparotomy Group (A) Fatsing for at least 6 hours pre-operative, No restriction of IV fluids and traditional analgesia including opiates. Post-operative Ambulation-as per patients' own request, Removal of urinary catheter when patient ambulates, patient will keep fasting for 3 days postoperative, oral fluids for 3 days, semi-solid for another 3 days and then can take full diet, removal of nasogastric tube just before starting oral fluids, drain removal just before discharge.

Group (B) Preoperative information, education and counselling, If possible, Clear fluids are allowed up to 2 h and solids up to 6 h prior to induction of anaesthesia, Short acting anesthetic agents,avoid opioid agents, Post operative nausea and vomiting prophylaxis, Patient will wear well-fitting compression stockings and receive pharmacological prophylaxis with LMWH. Encourage to mobilize out of bed after effect of general anesthesia has weaned off, Chewing gum, oral magnesium and alvimopan can be started early postoperatively, Initiation of feeding-Oral sips on day 1, step up day 2 onward, Removal of nasogastric tube-immediately after surgery after aspirating the gastric content through nasogastric tube, Removal of urinary catheter-after weaning from the effect of general anesthesia and drain removal -anytime within 24 hours;drain will not be removed if fluid is bilious or pus.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery
Anticipated Study Start Date :
Dec 1, 2020
Anticipated Primary Completion Date :
Nov 30, 2021
Anticipated Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Conventional

Fatsing for at least 6 hours pre-operative, No restriction of IV fluids and traditional analgesia including opiates. Post-operative Ambulation-as per patients' own request, Removal of urinary catheter when patient ambulates, patient will keep fasting for 3 days postoperative, oral fluids for 3 days, semi-solid for another 3 days and then can take full diet, removal of nasogastric tube just before starting oral fluids, drain removal just before discharge.

ERAS

Preoperative information, education and counselling, If possible, Clear fluids are allowed up to 2 h and solids up to 6 h prior to induction of anaesthesia, Short acting anesthetic agents,avoid opioid agents, Post operative nausea and vomiting prophylaxis, Patient will wear well-fitting compression stockings and receive pharmacological prophylaxis with LMWH. Encourage to mobilize out of bed after effect of general anesthesia has weaned off, Chewing gum, oral magnesium and alvimopan can be started early postoperatively, Initiation of feeding-Oral sips on day 1, step up day 2 onward, Removal of nasogastric tube-immediately after surgery after aspirating the gastric content through nasogastric tube, Removal of urinary catheter-after weaning from the effect of general anesthesia and drain removal -anytime within 24 hours;drain will not be removed if fluid is bilious or pus.

Combination Product: ERAS protocols
ERAS protocols including avoidance of prolonged pre-operative fasting and early removal of Ryle, surgical drains and urinary catheter
Other Names:
  • Fast-track surgery protocols
  • Combination Product: Early oral feeding
    Chewing gum, oral magnesium and alvimopan can be started early postoperatively, Initiation of feeding-Oral sips on day 1, step up day 2 onward

    Combination Product: Prophylaxis against DVT
    Patient will wear well-fitting compression stockings and receive pharmacological prophylaxis with LMWH. Encourage to mobilize out of bed after effect of general anesthesia has weaned off.

    Outcome Measures

    Primary Outcome Measures

    1. Length of hospital stay [Up to one month]

      In days

    Secondary Outcome Measures

    1. Time to ambulation [Up to one month]

      in hours

    2. Time to first flatus [Up to one month]

      In hours

    3. Time to first fluid diet [Up to one month]

      In hours

    4. Time to removal of drains [Up to one month]

      In hours

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Pateint presented with acute abdomen necessitating urgent GIT surgery
    Exclusion Criteria:
    • Known Chronic kidney disease/ Chronic liver disease patients Patients with history of chronic steroid abuse. Patient requiring Positive Pressure Ventilator support post operatively for more than 12 hours.

    Patient presented with Acute Appendicitis or Acute Cholecystitis. Patient refusing for consent

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Assiut University

    Investigators

    • Study Director: Abd Allah Badawy, MD, Prof. Dr.
    • Study Chair: Ashraf A Helmy, MD, Prof. Dr.
    • Study Chair: Ahmed A Abd ElMotleb, MD, Dr.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Ramy Raouf Rida Naguib, Resident doctor, Assiut University
    ClinicalTrials.gov Identifier:
    NCT04584060
    Other Study ID Numbers:
    • ERAS in emergency
    First Posted:
    Oct 12, 2020
    Last Update Posted:
    Oct 12, 2020
    Last Verified:
    Oct 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 12, 2020