Clinical trial NCT04584060: Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery
Official title: Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Patient Presented With Acute Abdomen
Patient Undergoing Urgent GIT Surgery
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presented with acute abdomen or surgical peritonitis that require urgent abdominal surgery

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Length of hospital stay
timeFrame: Up to one month
Secondary outcomes:
measure: Time to ambulation
timeFrame: Up to one month
measure: Time to first flatus
timeFrame: Up to one month
measure: Time to first fluid diet
timeFrame: Up to one month
measure: Time to removal of drains
timeFrame: Up to one month
Other outcomes:
Locations:
Study officials:
affiliation: Prof. Dr.
name: Abd Allah Badawy, MD
role: STUDY_DIRECTOR
affiliation: Prof. Dr.
name: Ashraf A Helmy, MD
role: STUDY_CHAIR
affiliation: Dr.
name: Ahmed A Abd ElMotleb, MD
role: STUDY_CHAIR
References:
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citation: Kehlet H, Wilmore DW. Fast-track surgery. Br J Surg. 2005 Jan;92(1):3-4. doi: 10.1002/bjs.4841. No abstract available.
citation: 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.
citation: 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.
citation: 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.