Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery
NCT ID: NCT04584060
Last Updated: 2020-10-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2020-12-01
2022-02-28
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
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.
ERAS protocols
ERAS protocols including avoidance of prolonged pre-operative fasting and early removal of Ryle, surgical drains and urinary catheter
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
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.
Interventions
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ERAS protocols
ERAS protocols including avoidance of prolonged pre-operative fasting and early removal of Ryle, surgical drains and urinary catheter
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
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
Patient presented with Acute Appendicitis or Acute Cholecystitis. Patient refusing for consent
18 Years
ALL
No
Sponsors
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Assiut University
OTHER
Responsible Party
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Ramy Raouf Rida Naguib
Resident doctor
Principal Investigators
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Abd Allah Badawy, MD
Role: STUDY_DIRECTOR
Prof. Dr.
Ashraf A Helmy, MD
Role: STUDY_CHAIR
Prof. Dr.
Ahmed A Abd ElMotleb, MD
Role: STUDY_CHAIR
Dr.
Central Contacts
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References
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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.
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.
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.
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.
Kehlet H, Wilmore DW. Fast-track surgery. Br J Surg. 2005 Jan;92(1):3-4. doi: 10.1002/bjs.4841. No abstract available.
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.
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.
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.
Other Identifiers
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ERAS in emergency
Identifier Type: -
Identifier Source: org_study_id
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