Objective: comparison of two techniques for Transverse Exposure on the cesarean section process in obese patients (Innovative versus routine technique).
Study design: Clinical trial study by random selection samples via single blind method from obese patients who are candidiate for cesarean section in one hospital and will be randomly allocate into two groups (intervention and control) .then we will compare effect of two tecnique on the surgical process.
Samples: 130 people (65 participants in each group) with inclusion creteria: no history of numerous surgery, heart diseases and respiratory problems and exclusion creteria: The creation of any complication in duration of surgery and anaesthesia.
Intervention: In the intervention method, we will use an innovative method by a simple tool made of two non penetrating towel clips and a suction tube for lifting the abdominal muscles. This approach not only lifts and pulls the abdominal muscles, but also decreases pressure on diaphragm and thorax. After prepping and draping, by using two non penetrating towel clips, the abdominal skin is held in lateral areas. Then a suction tube is passed from the rings of the clips and lift toward up and attach to the stand of anesthesia screen. By applying this method, the sagging abdominal muscles will be away of the working area.In control group will use adhesive tape.
Independed variable (interventions):
Intervention 1: inovative technique for Transverse Exposure
Intervention2: routine tecniques for Transverse Exposureby adhesive tape
Depended variable (primary outcomes): surgical proccess includs duration between anesthesia induction and surgical incision, the baby exit time, the duration time between the baby exit and wound suture and the surgery duration time. The blood loss will be quantified by counting the sponges which are consumed during surgery.
Secondary outcome: satisfaction of gynecologist and scrub.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015083018553N3
Registration date:2015-10-24, 1394/08/02
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-10-24, 1394/08/02
Registrant information
Name
Leila Sadati
Name of organization / entity
Alborz Universty of Medical Scincences
Country
Iran (Islamic Republic of)
Phone
+98 26 3253 4221
Email address
sadati@abzums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Alborz University of Medical Sciences
Expected recruitment start date
2015-10-02, 1394/07/10
Expected recruitment end date
2016-01-30, 1394/11/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of two techniques for Transverse Exposure on the cesarean section process in obese patients (Innovative versus routine technique).
Public title
Different Exposure for Caesarean section in obese patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: admission for doing cesarean section for the first or second time; no history of lung and heart diseases; no history of bleeding disorders; surgery performed by surgeons with comparable experience who often do cesarean sections by similar method and in similar time frame
Exclusion criteria:Occurrence of intraoperative complications during surgery such as bleeding; severe muscle adhesion which leads to prolong surgical procedure
Age
To 45 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
130
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Randomization will be done using the enclosed envelope
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Alborz university of medical sciences
Street address
Department of poone. 45metri golshahr ST. Shahid beheshti ST.
City
Karaj
Postal code
Approval date
2015-08-26, 1394/06/04
Ethics committee reference number
Abzums.rec.1394.47
Health conditions studied
1
Description of health condition studied
obesity
ICD-10 code
Y60.0
ICD-10 code description
During surgical operation
Primary outcomes
1
Description
duration time between of anesthesia induction and surgical incision
Timepoint
after intervention
Method of measurement
Calculate the time in minutes
2
Description
the duration time between the baby exit and wound suture
Timepoint
after intervention
Method of measurement
calculate time in minute
3
Description
counting the sponges which are consumed during surgery for estimation of bleeding
Timepoint
after intervention
Method of measurement
counting and Weighting of sponges
Secondary outcomes
1
Description
among of satisfaction
Timepoint
after intervention
Method of measurement
question
Intervention groups
1
Description
Intervention: use of simple tool made of two non penetrating towel clips and a suction tube for lifting the abdominal muscles
Category
Other
2
Description
Control:use of adhesive tape for lifting the abdominal muscles as a routine method .
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
kamali hospital
Full name of responsible person
dr banafsheh mashak
Street address
Kamali hoapitaL. ShohadaSQ. GazvinST. Karaj.
City
Karaj
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Alborz university of medical sciences
Full name of responsible person
Mohammad qaravi
Street address
Poone department.45 GolshahrSt. Karaj
City
Karaj
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 of Alborz university of medical sciences