Comparison of the consequences of using scalpel and electrosurgery to cut the anterior abdominal wall during cesarean section
Design
ُSingle blind clinical trials involving 88 participants with control groups and parallel groups, which will be randomly divided into two groups.
The permutation block randomization method will be used for randomization.
Settings and conduct
This single blind study will be performed in the operating room of Allameh Behlool Hospital in Gonabad on women candidates for cesarean section, and the participants will be divided into two groups, one in the surgical incision group with scalpel and the other group with electrosurgery. The study is double-blind. Participants are unaware of what is being done to them, and the analyzer is unaware of the approach taken by each group. The permutation block randomization method will be used for randomization.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Women candidates for non-emergency cesarean section, age range 18 to 45 years, 37 to 41 weeks of gestation.
Exclusion criteria:Participants should not have underlying disease, cardiopulmonary disease, skin disease, kidney failure, or immunodeficiency. If the person is addicted and sensitive to antibiotics, people who have taken anticoagulants should not be included in the study.
Intervention groups
Intervention group: includes people in whom abdominal incisions will be made using electrosurgery.
control group: Includes people in whom abdominal incisions will be made using scalpel.
Main outcome variables
Bleeding; patient's hemodynamic status; duration of surgery
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200501047254N1
Registration date:2020-05-21, 1399/03/01
Registration timing:registered_while_recruiting
Last update:2020-05-21, 1399/03/01
Update count:0
Registration date
2020-05-21, 1399/03/01
Registrant information
Name
Fatemeh Pouladkhay
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5722 3360
Email address
pouladkhay.fatemeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-09, 1399/02/20
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparative study of the outcome of scalpel and electrosurgical technique for anterior abdominal wall incision in cesarean section
Public title
comparative study of scalpel and electrosurgical technique for incision in cesarean section
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Cesarean section surgery
Patients age (18-45 years)
Pregnancy age 37 to 41 weeks
Pfannestiel skin incision
Satisfaction of participating in the project
Exclusion criteria:
Emergency cesarean section
Vertical skin incisions
Patients with incomplete records
Patient addiction
Chronic skin diseases such as psoriasis and eczema
Antibiotic-sensitive patients
Patients receiving anticoagulants
Patients with heart and lung problems
Underlying diseases such as diabetes, high blood pressure, liver disease, chronic anemia, kidney failure and immunodeficiency
Age
From 18 years old to 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
88
Randomization (investigator's opinion)
Randomized
Randomization description
It will be used to allocate groups through permutation block randomization. Patients participating in the study will be divided into two groups of 44 people using 4 blocks using letters A and B (for group equality). For permutation block randomization, the sealed envelope method will be used at random.
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding is such that the participant does not know what kind of actions will be taken for him; The analyst is also unaware of what is being done in each group. But since the measurement of the parameters is done by the researcher, the researcher will not be the blinding.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Mazandaran University of Medical Sciences
Street address
Sari, Farahabad Road,Mazandaran University of Medical Sciences, School of Paramedical Sciences
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Approval date
2020-05-04, 1399/02/15
Ethics committee reference number
IR.MAZUMS.REC.1399.135
Health conditions studied
1
Description of health condition studied
cesarean section
ICD-10 code
O75.82
ICD-10 code description
Onset (spontaneous) of labor after 37 completed weeks of gestation but before 39 completed weeks gestation, with delivery by (planned) cesarean section
Primary outcomes
1
Description
Bleeding during surgery
Timepoint
Bleeding is measured during surgery.
Method of measurement
The amount of bleeding will be calculated by measuring the weight difference between dry and wet swabs.
2
Description
The patient's hemodynamic status includes heart rate and blood pressure
Timepoint
Before and after surgical incision
Method of measurement
The patient's heart rate is recorded from an anesthesia monitor and blood pressure is measured using a manometer
3
Description
Duration of surgery
Timepoint
From the beginning to the end of the surgery
Method of measurement
Using a timer
4
Description
Surgical incision time
Timepoint
From the moment of surgical incision to the end of incision and reaching the uterus
Method of measurement
Using a timer
5
Description
Baby's Apgar
Timepoint
1 and 5 minutes after birth
Method of measurement
observation
Secondary outcomes
1
Description
Patient pain after surgery
Timepoint
1, 4, 8, 16 and 24 hours after surgery
Method of measurement
Numerical Pain Rating Scale
2
Description
Hospital costs
Timepoint
After surgery
Method of measurement
Record the number of disposable items used during the operation, including yarns, cutter plates, cutter pens, the number of gases used, and total costs using the hospital's information system.
Intervention groups
1
Description
Intervention group: Surgical incision with electrosurgery
Category
Treatment - Surgery
2
Description
Control group: Surgical incision with ُScalpel
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Allameh Behlool Gonabadi Hospital
Full name of responsible person
Azam Sadat Mahmoudian
Street address
Saadi St., Vahdat Blvd., Allameh Behlool Gonabadi Hospital
City
Gonabad
Province
Razavi Khorasan
Postal code
961797852
Phone
+98 51 5723 6833
Fax
+98 51 5723 6160
Email
javadi.a@gmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. Majid Saeedi
Street address
Sari, Imam Square, Joibar Three Ways, at the beginning of Valiasr Highway, Central Headquarters of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Fax
+98 11 3335 2725
Email
magsaeedi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Pouladkhay
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical technology
Street address
Saadi St. 25،First Alley، No. 15
City
Gonabad
Province
Razavi Khorasan
Postal code
9691738135
Phone
+98 51 5722 3360
Email
pouladkhay.fatemeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hooshang Akbari
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Sari, Imam Square, Joibar Three Ways, at the beginning of Valiasr Highway, Central Headquarters of Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
۴۸۱۵۷۳۳۹۷۱
Phone
+98 11 3304 4000
Email
Hooshangakbari48@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Fatemeh Pouladkhay
Position
Master Student
Latest degree
Bachelor
Other areas of specialty/work
Surgical technology
Street address
Saadi St., Saadi 25, No. 15
City
Gonabad
Province
Razavi Khorasan
Postal code
9691738135
Phone
+98 51 5722 3360
Email
pouladkhay.fatemeh@gmail.com
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
Not applicable
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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available