Protocol summary

Summary
Purpose: To evaluate laparoscopic appendectomy during complicated acute appendicitis treatment Method: In this study, all patients suspected of having complicated acute appendicitis undergo further investigation. Once the diagnosis is established, two types of surgery are explained for the patients (Open and Laparoscopic). After taking the informed consent, the patients enter the study voluntarily and are randomly assigned in Open and Laparoscopic Groups. A team of surgeons and senior assistants working in Sina Hospital performs the surgery. Minimum number of 48 patients undergoes the surgery in each group. Interventions: Open Appendectomy is performed for the patients in the control group and Laparoscopic Appendectomy in the experiment group. Inclusion Criteria: Patients suspected of having complicated acute appendicitis except for the definite cases of abscesses and phlegmon. Exclusion Criteria: History of abdominal or pelvic surgery, patients who are not diagnosed with complicated acute appendicitis during the operation by surgeon or pathologist after the surgery, diagnosis of abscesses and phlegmon, and pregnant mothers. Consequences: Primary Outcome: Comparing the length of surgery; Secondary Outcome: Surgical site infection, intra-abdominal abscess, post-operative pain, complications such as nosocomial infections, incisional hernia, etc., length of stay, and the need for reoperation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015102724747N1
Registration date: 2017-06-06, 1396/03/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-06-06, 1396/03/16
Registrant information
Name
Amir Mangouri Miandoab
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 8229
Email address
mangouria@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2015-11-22, 1394/09/01
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Laparoscopic versus open appendectomy: compare outcomes and complications in the treatment of complicated appendicitis
Public title
Laparoscopic versus open appendectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Patients suspected of having complicated acute appendicitis Exclusion criteria: History of abdominal or pelvic surgery; people who have been diagnosed abscess or phlegmon
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 96
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics Committee of Tabriz University of Medical Sciences
Street address
International Relations Office, No 2 Central Building, Golgasht avenue, Tabriz University of Medical Sciences
City
Tabriz
Postal code
5165665931
Approval date
2016-12-26, 1395/10/06
Ethics committee reference number
IR.TBZMED.REC.1395.1027

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
Duration of surgery
Timepoint
During surgical intervention
Method of measurement
Timer

Secondary outcomes

1

Description
Surgical site infection
Timepoint
During hospitalization, one month after discharge
Method of measurement
Follow up

2

Description
Intra-abdominal abscess
Timepoint
During hospitalization, one month after discharge
Method of measurement
Follow up

3

Description
Pain After Surgery
Timepoint
During hospitalization
Method of measurement
Follow up

4

Description
Complications such as nosocomial infections, hernia incisional and ...
Timepoint
During hospitalization, one month after discharge
Method of measurement
Follow up

5

Description
Length of hospitalization after surgery
Timepoint
During hospitalization
Method of measurement
Timer

6

Description
The need for further surgery
Timepoint
During hospitalization, one month after discharge
Method of measurement
Follow up

Intervention groups

1

Description
Control Group: Open Appendectomy
Category
Treatment - Surgery

2

Description
Intervention Group: Laparoscopic Appendectomy
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Vahideh Nemati
Street address
Azadi Ave, Hafez Square
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Akram Azari
Street address
3rd Floor, Faculty of Medicine, opposite the headquarters of the University, University Avenue
City
Tabriz
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, Tabriz University of Medical Sciences
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
Tabriz University Of Medical Sciences
Full name of responsible person
Amir Mangouri
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Azadi Ave, Hafez Square, Sina hospital
City
Tabriz
Postal code
Phone
+98 41 3330 8229
Fax
Email
amir.mangouri@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Amir Mangouri
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Azadi Ave, Hafez Square, Sina hospital
City
Tabriz
Postal code
Phone
+98 41 3330 8229
Fax
Email
amir.mangouri@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University Of Medical Sciences
Full name of responsible person
Amir Mangouri
Position
Resident of General Surgery
Other areas of specialty/work
Street address
Azadi Ave, Hafez Square, Sina hospital
City
Tabriz
Postal code
Phone
+98 41 3330 8229
Fax
Email
amir.mangouri@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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