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The effectiveness of enhanced recovery after surgery (ERAS) program compared to the usual protocol on pain severity in patients undergoing surgery for acute appendicitis

Protocol summary

Study aim
Evaluating the effectiveness of enhanced recovery after surgery (ERAS) protocol compared to the usual protocol on pain severity in patients undergoing surgery for acute appendicitis
Design
This study is a randomized controlled clinical trial without blinding. Patients are randomly divided into two separate groups (using a randomly generated sequence using a computer and by sealed, opaque and sequenced envelopes).
Settings and conduct
This trial is conducted on patients with acute appendicitis in Imam Reza Hospital, Mashhad, Iran.
Participants/Inclusion and exclusion criteria
All patients aged between 18-65 years, with acute appendicitis undergoing surgery are included. The exclusion criteria are complicated appendicitis defined with one of these conditions; appendicular peritonitis, appendicular abscess, appendicular phlegmon.
Intervention groups
In one group, patients undergoing routine and standard preoperative care (such as using opioids to relieve pain, placing drains such as NGTube or Foley Catheter, if needed Npo), and in the second group patients undergoing ERAS protocol (such as early feeding, use of NSAIDs as analgesics, reduction of injection fluid volume, etc.) are included.
Main outcome variables
The severity of pain for each patient will be measured based on the Visual Analogue Scale (VAS scale), (between 0 and 10). Finally, the pain score will be divided into three groups: mild (0-2), moderate (3-7) and severe (8-10).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190423043356N2
Registration date: 2020-08-21, 1399/05/31
Registration timing: registered_while_recruiting

Last update: 2020-08-21, 1399/05/31
Update count: 0
Registration date
2020-08-21, 1399/05/31
Registrant information
Name
Amin Dalili
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3180 2557
Email address
daliliam@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of enhanced recovery after surgery (ERAS) program compared to the usual protocol on pain severity in patients undergoing surgery for acute appendicitis
Public title
The effectiveness of enhanced recovery after surgery (ERAS) on pain severity in patients with acute appendicitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-65 Patients with acute appendicitis Patients undergoing surgery for acute appendicitis
Exclusion criteria:
Appendicular peritonitis Appendicular abscess Appendicular phlegmon
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 76
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, individual randomization is used. The sequence of random numbers is generated using "Randomization.com" website with simple randomization method. Finally, the patients are divided into two separate groups by sealed, opaque and sequenced envelopes.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences Ethics Committee
Street address
Ibn-e-sina street, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Approval date
2020-01-28, 1398/11/08
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1398.852

Health conditions studied

1

Description of health condition studied
Acute appendicitis
ICD-10 code
K35
ICD-10 code description
Acute appendicitis

Primary outcomes

1

Description
Severity of postoperative pain
Timepoint
Once, 7 days after surgery
Method of measurement
Visual Analogue Scale (VAS scale)

Secondary outcomes

1

Description
Postoperative Ileus
Timepoint
30 days after surgery
Method of measurement
Physical examination

2

Description
Hospitalization period
Timepoint
During admission
Method of measurement
Number of admission days

3

Description
Postoperative complications
Timepoint
30 days after surgery
Method of measurement
Physical examination

Intervention groups

1

Description
Intervention group: ERAS program A- Before surgery: limit fasting to 6 hours before surgery, consumption of carbohydrate fluids up to 2 hours before surgery, reducing opioid consumption, reducing the volume of fluid intake to normal volume (normovolemic); prescribing anti-emetic drugs before and after surgery to reduce nausea and vomiting, normal blood sugar during the protocol, avoiding of drain usage, B- Postoperative: early oral feeding immediately after becoming conscious, make the patient to walk as soon as possible to prevent from ileus, administration of non-opioid analgesics to reduce pain and ileus and improve nutrition C- Postoperative follow-up: Evaluation for complications of surgery including wound infection, need for readmission
Category
Treatment - Other

2

Description
Control group: routine care before and after surgery which includes the following : using opioids to relieve pain, using drains such as a nasogastric tube (NG-tube), or Foley catheter, in case of needing to keep the patient in fasting situation (NPO)
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Amin Dalili
Street address
Imam Reza Hospital, Ibn-e-Sina St
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3852 5255
Email
daliliam@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Tafaghodi
Street address
Vice President for Research & Technology, Ghoreshi Building, Daneshgah St
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3841 1538
Email
vcresearch@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Dalili
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3180 2557
Fax
+98 51 3858 3834
Email
daliliam@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Dalili
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3180 2557
Fax
+98 51 3858 3834
Email
daliliam@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Amin Dalili
Position
Asistant professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Surgical Oncology Research Center, Imam Reza Hospital, Mashhad University of Medical Sciences
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3180 2557
Fax
+98 51 3858 3834
Email
daliliam@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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