Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery

NCT ID: NCT04584060

Last Updated: 2020-10-12

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2022-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Patient Presented With Acute Abdomen Patient Undergoing Urgent GIT Surgery

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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

Intervention Type COMBINATION_PRODUCT

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

Early oral feeding

Intervention Type 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

Prophylaxis against DVT

Intervention Type 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.

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

Intervention Type 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

Intervention Type 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.

Intervention Type COMBINATION_PRODUCT

Other Intervention Names

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Fast-track surgery protocols

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ramy Raouf Rida Naguib

Resident doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

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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Ramy RR Naguib, MBBCH

Role: CONTACT

01111961657

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.

Reference Type BACKGROUND
PMID: 21487688 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23014834 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23155304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28507993 (View on PubMed)

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

Reference Type RESULT
PMID: 15635603 (View on PubMed)

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.

Reference Type RESULT
PMID: 25671587 (View on PubMed)

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.

Reference Type RESULT
PMID: 28492816 (View on PubMed)

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.

Reference Type RESULT
PMID: 21286218 (View on PubMed)

Other Identifiers

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ERAS in emergency

Identifier Type: -

Identifier Source: org_study_id

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