Objectives: We conducted this randomized controlled study to find the complications of open appendectomy using small access incision and compare with the complications of open appendectomy using classic McBurney’s incision.
Patients and methods: Patients with acute appendicitis full filling the study requirements who are hospitalized in 2014 at Besat Hospital, Hamadan University of Medical Sciences are enrolled in this study. Patients are randomly allocated in two groups using simple randomization method with random number table. Patients who undergo open appendectomy using small access incision are considered as the case group (n=45) and the others who undergo open appendectomy using classic McBurney’s incision are considered as the control group (n=45). A questionnaire is prepared for each patient. All patients are followed for 6 months after surgery. Data of patients including operative time, days of hospitalization, surgical wound infection, analgesic consumption and satisfaction with wound appearance are recorded and compared between two groups. Data analyses are performed with statistical software (IBM SPSS Statistics for Windows, Version 20.0, IBM Corp., Armonk, NY, USA). Comparisons are made with 2-tailed t test (quantitative data) and the Fisher exact test (qualitative data). Statistical significance is defined by P ≤ .05.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201411288729N7
Registration date:2015-10-16, 1394/07/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-10-16, 1394/07/24
Registrant information
Name
Seyed Mohammad Reza Javadi
Name of organization / entity
Hamadan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0061
Email address
mr.javadi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Hamadan University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-03-20, 1393/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Appendectomy using Small Access versus Classic McBurney’s Incision: A Randomized-Controlled Trial
Public title
Comparison of Two Different Types of Incision in the Surgery of Acute Appendicitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Patients in whom the appendicitis is documented with ultrasound or computed tomography scan.
2. Patients with the signs and symptoms of acute appendicitis with Alvarado score of more than five.
Alvarado score is as follows:
- Abdominal pain that migrates to the right iliac fossa
- Anorexia (loss of appetite) or ketones in the urine
- Nausea or vomiting
- Tenderness in the right iliac fossa
- Rebound tenderness
- Fever of 37.3 °C or more
- Leukocytosis, or more than 10000 white blood cells per microliter in the serum
- Neutrophilia, or an increase in the percentage of neutrophils in the serum white blood cell count.
Tenderness in the right lower quadrant and leukocytosis, are assigned two points, and the six other factors are assigned one point each, for a possible total score of ten points.
Exclusion criteria:
1. Patients who are found during the appendectomy surgery that have no appendicitis despite the Alvarado score of more than five.
2. Patients with signs and symptoms of peritonitis and its complications including abdominal guarding, diffuse abdominal rigidity development of ileus paralyticus, shock, acute renal failure, peritoneal abscess, and sepsis.
Age
From 5 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Patients in both of case and control groups are similar in terms of age, gender and body mass index.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Hamedan University of Medical Science
Street address
Hamedan University of Medical Science, Mahdiye Blvd.
City
Hamedan
Postal code
Approval date
2014-06-25, 1393/04/04
Ethics committee reference number
p/16/35/9/1542
Health conditions studied
1
Description of health condition studied
Acute appendicitis
ICD-10 code
k35.8
ICD-10 code description
Acute appendicitis, other and unspecified
Primary outcomes
1
Description
The total amount of analgesic consumption
Timepoint
Post-operative period until discharge from hospital
Method of measurement
Questionnaire- milligrams
2
Description
Operative time
Timepoint
End of operation
Method of measurement
Questionnaire- The time difference between the end and the start of operation/ minutes
3
Description
Hospital stay
Timepoint
At the time of discharge form hospital
Method of measurement
Questionnaire- the difference between the days of surgery and discharge from hospital/ days
Secondary outcomes
1
Description
Surgical site infection
Timepoint
1 week, 1 month, 3 and 6 months after surgery
Method of measurement
Questionnaire- discharge or redness or pain in/around surgical wound-examined by the surgeon
2
Description
Patient's satisfaction with scar
Timepoint
1 month, 3 and 6 months after surgery
Method of measurement
Questionnaire- patients give score to satisfaction with their scar from one to ten- one is the least satisfaction and ten is the most
Intervention groups
1
Description
Small access incision in case group. This is a two centimeters, medial and inferior of right anterior superior iliac spine incision and we use Babkak Forceps in this surgery.
Category
Treatment - Surgery
2
Description
Conventional Mc.burney incision in control group
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat hospital
Full name of responsible person
Mohamad Reza Javadi
Street address
Besat hospital, Ayatollah Motahari Blvd.
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology Hamedan University of Medical Science
Full name of responsible person
Heydar Tavilani
Street address
Hamedan University of Medical Science, Mahdiye Blvd.
City
Hamedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology Hamedan University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Seyed Yahya Zarghami
Position
general surgery resident
Other areas of specialty/work
Street address
Besat hospital, Ayatollah Motahari Blvd.
City
Hamedan
Postal code
Phone
+98 81 3264 0061
Fax
Email
syzarghami@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Seyed Mohamad Reza Javadi
Position
General surgeon
Other areas of specialty/work
Street address
Besat hospital, Ayatollah Motahari Blvd.
City
Hamedan
Postal code
Phone
+98 81 3264 0020
Fax
Email
mr.javadi@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Science
Full name of responsible person
Seyed Yahya Zarghami
Position
general surgery resident
Other areas of specialty/work
Street address
Besat hospital, Ayatollah Motahari Blvd.
City
Hamedan
Postal code
Phone
+98 81 3264 0061
Fax
Email
Syzarghami@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)