Patient Presented With Acute AbdomenNCT04584060
Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery
An observational study of Patient Presented With Acute Abdomen and Patient Undergoing Urgent GIT Surgery, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Presented With Acute Abdomen, Patient Undergoing Urgent GIT Surgery
- What is being tested?
- ERAS protocols, Early oral feeding and Prophylaxis against DVT
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 28 Feb 2022
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients presented with acute abdomen or surgical peritonitis that require urgent abdominal surgery
Who may be able to join
- Pateint presented with acute abdomen necessitating urgent GIT surgery
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the 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.
- Being tested
- ERAS protocols, Early oral feeding, Prophylaxis against DVT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ERAS protocolsCombination product
Also called Fast-track surgery protocols
ERAS protocols including avoidance of prolonged pre-operative fasting and early removal of Ryle, surgical drains and urinary catheter
Early oral feedingCombination 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 DVTCombination 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Combination Product: ERAS protocols; Combination Product: Early oral feeding; Combination Product: Prophylaxis against DVT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of hospital stay
In days
Measured: Up to one month
Secondary outcomes (4)
Time to ambulation
in hours
Measured: Up to one month
Time to first flatus
In hours
Measured: Up to one month
Time to first fluid diet
In hours
Measured: Up to one month
Time to removal of drains
In hours
Measured: Up to one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start1 Dec 2020 (estimated)
- Primary completion30 Nov 2021 (estimated)
- Study completion28 Feb 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Patient Presented With Acute AbdomenStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Raouf Rida Naguib, Assiut University
- Investigators
- Abd Allah Badawy, MD, Study director, Prof. Dr.Ashraf A Helmy, MD, Study chair, Prof. Dr.Ahmed A Abd ElMotleb, MD, Study chair, Dr.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04584060
- Sponsor's protocol ID
- ERAS in emergency
- Status last verified
- Oct 2020
- First submitted
- 5 Oct 2020
- Last updated
- 12 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After completion of study
Publications
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.
PubMed 21487688Ansari 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.
PubMed 23014834Lyon 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.
PubMed 23155304Paduraru 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.
PubMed 28507993Kehlet H, Wilmore DW. Fast-track surgery. Br J Surg. 2005 Jan;92(1):3-4. doi: 10.1002/bjs.4841. No abstract available.
PubMed 15635603ERAS 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.
PubMed 25671587Liu 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.
PubMed 28492816Abraham 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.
PubMed 21286218
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional VS Enhanced Recovery After Surgery Protocols in Emergency GIT Surgery
- ClinicalTrials.gov ID
- NCT04584060
- Acronym / sponsor ID
- ERAS in emergency
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 30 Nov 2021 (estimated)
- Study completion
- 28 Feb 2022 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Combination Product: ERAS protocols, Combination Product: Early oral feeding, Combination Product: Prophylaxis against DVTPreoperative 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presented with acute abdomen or surgical peritonitis that require urgent abdominal surgery
Key inclusion criteria (1 listed)
- Pateint presented with acute abdomen necessitating urgent GIT surgery
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ERAS protocolsAlso: Fast-track surgery protocolsERAS protocols including avoidance of prolonged pre-operative fasting and early removal of Ryle, surgical drains and urinary catheter | Combination product | ERAS |
| Early oral feedingChewing 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 | ERAS |
| Prophylaxis against DVTPatient 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. | Combination product | ERAS |
Primary outcome
Length of hospital stay
Time frame: Up to one month
In days
4 secondary outcomes
Time to ambulation
Time frame: Up to one month
Time to first flatus
Time frame: Up to one month
Time to first fluid diet
Time frame: Up to one month
Time to removal of drains
Time frame: Up to one month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2020.
- Background: PubMed 21487688Andrews 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.
- Background: PubMed 23014834Ansari 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.
- Background: PubMed 23155304Lyon 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.
- Background: PubMed 28507993Paduraru 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.
- Results publication: PubMed 15635603Kehlet H, Wilmore DW. Fast-track surgery. Br J Surg. 2005 Jan;92(1):3-4. doi: 10.1002/bjs.4841. No abstract available.
- Results publication: PubMed 25671587ERAS 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.
- Results publication: PubMed 28492816Liu 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.
- Results publication: PubMed 21286218Abraham 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.
- Individual participant dataSharing planned: Yes. After completion of study
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abd Allah Badawy, MD study director
Prof. Dr.
Ashraf A Helmy, MD study chair
Prof. Dr.
Ahmed A Abd ElMotleb, MD study chair
Dr.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Presented With Acute Abdomen and Patient Undergoing Urgent GIT Surgery, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramy RR Naguib, MBBCH (01111961657, ramyraouf69@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of hospital stay (time frame: Up to one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04584060, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Oct 2020; AzTrials last refreshed its copy on 29 Oct 2026.