Evaluating surgical and patient Outcomes Using Normal Saline Enema for Bowel Preparation Before Benign Gynecologic Laparoscopic Surgeries
Design
This is a randomized, single-blind, single-center clinical trial with parallel groups on 112 patients. The rand function of the Excel software was used for randomization.
Settings and conduct
This study is performed in Arash hospital on 112 female patients candidates for level2 and 3 laparoscopic surgery aged 18-65 years. Patients are randomly divided into two groups of enema before surgery and without enema. The physician will check the outcome will be blind from the study is used to analyze the data. Due to the type of study, the patient will not be blind in this study.
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Participants/Inclusion and exclusion criteria
Inclusion Criteria: Patients who are candidates for level 2 and 3 laparoscopic gynecologic surgeries
Exclusion criteria: Patients who are at risk for intestinal injury during laparoscopy and are candidates for complete bowel preparation before surgery such as: a history of multiple previous surgeries with many adhesion, severe endometriosis in cul de sac and bowel/large uterus with adhesion in hysterectomy, cancer surgery, surgery in sever PTD with abcess. Patients who are candidates for level 1 laparoscopic surgeries such as TL and diagnostic laparoscopy. Patients who are candidates for level 4 laparoscopy surgeries such as lymphadenectomy,severe endometriosis, presacral neurectomy History of patients intestinal diseases such as IBS and colitis Severe obesity (BMI>35)
Intervention groups
Intervention for this group is enema with normal saline once at 11 pm ( the night before the operation) and once at 6 am in the morning of the operation.
Control group: without intervention.
Main outcome variables
surgeon's satisfaction from intraoperative visualization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20110530006640N6
Registration date:2020-07-21, 1399/04/31
Registration timing:registered_while_recruiting
Last update:2020-07-21, 1399/04/31
Update count:0
Registration date
2020-07-21, 1399/04/31
Registrant information
Name
Zahra Asgari
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7788 8755
Email address
asgariza@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-07-20, 1399/04/30
Expected recruitment end date
2021-01-19, 1399/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Surgical and Patient Outcomes Using Normal Saline Enema for Bowel Preparation Before Benign Gynecologic Laparoscopic Surgeries
Public title
Surgical outcomes using bowel enema before benign gynecologic laparoscopic surgeries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are candidates for level 2 and 3 laparoscopic gynecologic surgeries
Exclusion criteria:
Patients who are at risk for intestinal injury during laparoscopy and are candidates for complete bowel preparation before surgery such as : a history of multiple previous surgery with many adhesion, sever endometriosis in cul de sac and bowel/large uterus with adhesion in hysterectomy,cancer surgery, surgery in sever PTD with abcess.
Patients who are candidates for level 1 laparoscopic surgeries such as TL and diagnostic laparoscopy.
Patients who are candidates for level 4 laparoscopy surgeries such as lymphadenectomy,sever endometriosis, presacral neurectomy
History of patients intestinal diseases such as IBS and colitis
Severe obesity (BMI>35)
Age
From 18 years old to 65 years old
Gender
Female
Phase
3
Groups that have been masked
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
112
Randomization (investigator's opinion)
Randomized
Randomization description
Random allocation methods were blocks that were designed by the epidemiologist using version 13 Stata software. The number of blocks is 6. The random allocation list of patients is only at the disposal of the clinic nurse.To hide the random allocation process, 112 treatment cards written in order. The cards are placed in sealed envelopment. When the physician determined that patient is eligible to enter the study, the nurse provides the physician with an envelope related to the type of intervention for check of the outcome, the commenting physician is unaware of the type of intervention. A statistical expert who is separated from the study is used to analyze the data. Due to the type of study, the patient will not be blind in this study.
Blinding (investigator's opinion)
Double blinded
Blinding description
for evaluating the outcomes, The physician is unaware of the type of intervention. A statistical expert who is separated from the study is used to analyze the data. Due to the type of study, the patient will not be blind in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Research and Technology Dept, Sixth Floor of Central University Building, Corner of Quds Street, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-03-04, 1398/12/14
Ethics committee reference number
IR.TUMS.MEDICINE.REC.1398.944
Health conditions studied
1
Description of health condition studied
Benign gynecology disease
ICD-10 code
N85
ICD-10 code description
Other noninflammatory disorders of uterus, except cervix
Primary outcomes
1
Description
Surgeon's satisfaction from intraoperative visualization and bowel handling
Timepoint
Immediately after surgery
Method of measurement
Questionnaire
2
Description
Complication of surgery such as viscoralinjury , fever, decrease of hemoglobin
Timepoint
Intraoperative and after surgery
Method of measurement
Patient File
Secondary outcomes
1
Description
Duration of surgery
Timepoint
End of surgery
Method of measurement
Cornometer
2
Description
Duration of hospitalization
Timepoint
Time of the discharge from the hospital
Method of measurement
Day/Patient file
Intervention groups
1
Description
Intervention group:Patients eat light meals and fluids the night before surgery and they become NPO from 12 midnight . Intervention for this group is enema with normal saline once at 11 pm ( the night before the operation) and once at 6 am in the morning of operation.
Category
Treatment - Other
2
Description
Control group:Patients eat light meals and fluids the night before surgery and they become NPO from 12 midnight
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women Hospital
Full name of responsible person
Dr.Zahra Asgari
Street address
Arash Women 's Hospital, Eastern 162th St, Baghdarnia st, Resalat Highway, Tehranpars, Tehran ,Iran.
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 3283
Fax
Email
Dr.zahra.asgari@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr.Sahraeian
Street address
Qods St, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Email
vcr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Zahra Asgari
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash Hospital, Rashid street ,Resalat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 8755
Fax
+98 21 7788 8751
Email
asgariza@sina.tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Zahra Asgari
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash Hospital, Rashid street ,Resalat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 8755
Fax
+98 21 7788 8751
Email
asgariza@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Zahra Asgari
Position
Associate professor
Latest degree
Medical doctor
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Arash Hospital, Rashid street ,Resalat highway
City
Tehran
Province
Tehran
Postal code
1653915981
Phone
+98 21 7788 8755
Fax
+98 21 7788 8751
Email
asgariza@sina.tums.ac.ir
Web page address
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
Undecided - It is not yet known if there will be a plan to make this available
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