Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery

NCT04584060 | Unknown

• 1 other identifier: ERAS in emergency
• Study Type: observational
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Patient Presented With Acute Abdomen; Patient Undergoing Urgent GIT Surgery

Outcome Measures

Primary Outcomes (1)

• Length of hospital stay

  In days

  Up to one month

Secondary Outcomes (4)

• Time to ambulation

  Up to one month

• Time to first flatus

  Up to one month

• Time to first fluid diet

  Up to one month

• Time to removal of drains

  Up to one month

Study Arms (2)

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; Combination Product: Early oral feeding; Combination Product: Prophylaxis against DVT

Interventions

ERAS protocols COMBINATION_PRODUCT

ERAS protocols including avoidance of prolonged pre-operative fasting and early removal of Ryle, surgical drains and urinary catheter

Also known as: Fast-track surgery protocols

ERAS

Early oral feeding COMBINATION_PRODUCT

Chewing gum, oral magnesium and alvimopan can be started early postoperatively, Initiation of feeding-Oral sips on day 1, step up day 2 onward

ERAS

Prophylaxis against DVT COMBINATION_PRODUCT

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.

ERAS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients presented with acute abdomen or surgical peritonitis that require urgent abdominal surgery

You may qualify if:

• Pateint presented with acute abdomen necessitating urgent GIT surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (8)

• Andrews EJ, McCourt M, O'Riordain MG. Enhanced recovery after elective colorectal surgery: now the standard of care. Ir J Med Sci. 2011 Sep;180(3):633-5. doi: 10.1007/s11845-011-0709-1. Epub 2011 Apr 13.

  PMID: 21487688 BACKGROUND

• Ansari D, Gianotti L, Schroder J, Andersson R. Fast-track surgery: procedure-specific aspects and future direction. Langenbecks Arch Surg. 2013 Jan;398(1):29-37. doi: 10.1007/s00423-012-1006-9. Epub 2012 Sep 27.

  PMID: 23014834 BACKGROUND

• Lyon A, Payne CJ, Mackay GJ. Enhanced recovery programme in colorectal surgery: does one size fit all? World J Gastroenterol. 2012 Oct 28;18(40):5661-3. doi: 10.3748/wjg.v18.i40.5661.

  PMID: 23155304 BACKGROUND

• Paduraru M, Ponchietti L, Casas IM, Svenningsen P, Zago M. Enhanced Recovery after Emergency Surgery: A Systematic Review. Bull Emerg Trauma. 2017 Apr;5(2):70-78.

  PMID: 28507993 BACKGROUND

• Kehlet H, Wilmore DW. Fast-track surgery. Br J Surg. 2005 Jan;92(1):3-4. doi: 10.1002/bjs.4841. No abstract available.

  PMID: 15635603 RESULT

• ERAS Compliance Group. The Impact of Enhanced Recovery Protocol Compliance on Elective Colorectal Cancer Resection: Results From an International Registry. Ann Surg. 2015 Jun;261(6):1153-9. doi: 10.1097/SLA.0000000000001029.

  PMID: 25671587 RESULT

• Liu VX, Rosas E, Hwang J, Cain E, Foss-Durant A, Clopp M, Huang M, Lee DC, Mustille A, Kipnis P, Parodi S. Enhanced Recovery After Surgery Program Implementation in 2 Surgical Populations in an Integrated Health Care Delivery System. JAMA Surg. 2017 Jul 19;152(7):e171032. doi: 10.1001/jamasurg.2017.1032. Epub 2017 Jul 19.

  PMID: 28492816 RESULT

• Abraham N, Albayati S. Enhanced recovery after surgery programs hasten recovery after colorectal resections. World J Gastrointest Surg. 2011 Jan 27;3(1):1-6. doi: 10.4240/wjgs.v3.i1.1.

  PMID: 21286218 RESULT

Study Officials

• Abd Allah Badawy, MD

  Prof. Dr.

  STUDY DIRECTOR

• Ashraf A Helmy, MD

  Prof. Dr.

  STUDY CHAIR

• Ahmed A Abd ElMotleb, MD

  Dr.

  STUDY CHAIR

Central Study Contacts

Ramy RR Naguib, MBBCH

CONTACT

01111961657; ramyraouf69@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: December 1, 2020
• Primary Completion: November 30, 2021
• Study Completion: February 28, 2022
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: By April 2022