Protocol summary

Study aim
This study aimed to evaluate the impact of short term and mid-term prophylactic appendectomy during laparoscopic surgery in patients with endometriosis.
Design
This randomized double-blind clinical trial, including 56 female patients with endometriosis, candidates for laparoscopic surgery will take place in Hazrat e Rasool hospital-Tehran. individuals will be divided randomly using random digits table in two equal groups (n1=n2=28).
Settings and conduct
After obtaining written informed consent, both groups will receive a prophylactic antibiotic prior to the surgery and then under general anesthesia, the intervention will be performed. In the intervention group, the appendix will be removed prophylactically during laparoscopic surgery for endometriosis.
Participants/Inclusion and exclusion criteria
Patients with endometriosis, laparoscopic surgery candidates, no history of appendectomy, informed consent form included in the study. exclusion criteria were considered as gastrointestinal endometriosis, acute appendicitis, pelvic pain with ethology other than endometriosis, Failure to prove the presence of endometriosis in surgery, unwillingness to continue the study and abnormal anatomical placement of appendix.
Intervention groups
The first group will undergo appendectomy with laparoscopy surgery and the second group will exclusively undergo laparoscopy surgery without appendectomy. two groups will compare with each other regarding short term consequences (duration of surgery, Lost blood volume, duration of hospitalization, complications after surgery in the hospital, The need for admission of analgesics during hospitalization) and also mid-term consequences (complications of 6 months after surgery, mid-term admission or hospitalization).
Main outcome variables
Duration of hospitalization, lost blood volume, pain, fever, morbidity, histopathological findings in appendices

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20150817023666N12
Registration date: 2019-01-14, 1397/10/24
Registration timing: retrospective

Last update: 2019-01-14, 1397/10/24
Update count: 0
Registration date
2019-01-14, 1397/10/24
Registrant information
Name
Abolfazl Mehdizadeh kashi
Name of organization / entity
Iran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 216651500
Email address
mehdizadeh.a@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-12-22, 1397/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of prophylactic appendectomy on outcome of therapeutic laparoscopy in patients with endometriosis
Public title
The effects of prophylactic appendectomy on short term and mid-term outcome of therapeutic laparoscopy in patients with endometriosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having endometriosis Laparoscopic surgery candidates No history of appendectomy Informed consent to enter the study
Exclusion criteria:
Gastrointestinal endometriosis Having acute appendicitis Pelvic pain with pathology other than endometriosis Failure to prove the presence of endometriosis in surgery Unwillingness to continue the study Abnormal anatomical placement of appendix
Age
No age limit
Gender
Female
Phase
2
Groups that have been masked
  • Participant
  • Data analyser
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization with blocks of size four will be used. Intervention and non-intervention groups allocation will be determined randomly with A or B and then all individuals in the two groups will be divided into the blocks using random digits.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participants and data analyser are blinded of the allocation of study groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran.
City
Tehran
Province
Tehran
Postal code
1986663311
Approval date
2018-01-23, 1396/11/03
Ethics committee reference number
IUMS.REC.1397.288

Health conditions studied

1

Description of health condition studied
Appendectomy
ICD-10 code
R83-R89
ICD-10 code description
Abnormal findings on examination of other body fluids, substances and tissues, without diagnosis

Primary outcomes

1

Description
Duration of hospitalization
Timepoint
During hospitalization after surgery and 6 months after surgery
Method of measurement
Medical file records and phone call

2

Description
Lost blood volume
Timepoint
During hospitalization after surgery and 6 months after surgery
Method of measurement
Blood test

3

Description
Pain
Timepoint
After surgery and 6 months after surgery
Method of measurement
Visual Analog Scale for Pain

4

Description
Fever
Timepoint
After surgery and 6 months after surgery
Method of measurement
Thermometer

5

Description
Morbidity
Timepoint
Short term and mid-term morbidity
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Histopathological findings in appendices
Timepoint
After surgery
Method of measurement
Pathology report

Intervention groups

1

Description
In the intervention group, the appendix will be removed prophylactically during laparoscopic surgery for endometriosis.
Category
Treatment - Surgery

2

Description
In control group laparoscopy without appendectomy will be performed.
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasoul-e-Akram Hospital
Full name of responsible person
Abolfazal Mehdizadehkashi
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Email
mehdizadehkashi.a@iums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Administration of Iran University of Medical Sciences (IUMS)
Street address
Iran University of Medical Sciences, Hemmat freeway, next to Milad tower, Tehran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 1000
Email
ivco@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadehkashi
Position
Professor of Obstetrics and Gynecology
Latest degree
Subspecialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6650 9283
Email
mehdizadehkashi.a@iums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Elahe Afshari
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1986663311
Phone
+98 21 2204 1853
Email
el_afshari@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abolfazl Mehdizadeh-kashi
Position
Professor of Obstetrics and Gynecology
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Rasoul Akram Hospital, Satarkhan St, Tehran
City
Tehran
Province
Tehran
Postal code
1449613131
Phone
+98 21 6650 9283
Email
amehdizadehkashi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of data like the main outcome or the same will be shared
When the data will become available and for how long
Access after 6 months after publication
To whom data/document is available
Data will be available for all researchers
Under which criteria data/document could be used
limitless
From where data/document is obtainable
For receiving data please be contacted with el_afshari@yahoo.com
What processes are involved for a request to access data/document
limitless
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