The purpose of this study is evaluation of effect of intraperitoneal catheter insertion on postopration complications of lepvic and ovarian laparascopy in female patients. Patients who are in fertility age with benign gynecologic disease that indicated for laparascopy were included, and patients who are pregnant; have IBD or IBS; high grade fever; and patients who have active infectious disease were excluded. This RCT study is conducted on 100 patients. Patients randomly were divided in to intervention and control group and insreted catheter in case group for 24 hours, respectively the pain and GI complications in patients will be copmared and evaluated
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017082335871N1
Registration date:2017-09-05, 1396/06/14
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-09-05, 1396/06/14
Registrant information
Name
Farid Moradian
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3323 3702
Email address
moradian.farid@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yasuj University of Medical Sciences
Expected recruitment start date
2017-01-19, 1395/10/30
Expected recruitment end date
2017-04-20, 1396/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of intra peritoneal catheter insertion on post operation complications of pelvic and ovarian laparscopy
Public title
Effect of catheter on laparascopy post operation complications
Purpose
Supportive
Inclusion/Exclusion criteria
all of patients are female in age of fertility with benign gynecologic disease that accepted to participate.
exclusion criteria: refuse to participation;BD or IBS disease; pregnancy; infection; high grade fever; and manifestation of any unpredictable problem that interrupt laparoscopy or catheter insertion
Age
From 15 years old to 49 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
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 Yasuj University of Medical Science
Street address
Yasuj University of Medical Sciences, Motahari street, Yasuj city
City
Yasuj
Postal code
Approval date
2017-01-21, 1395/11/02
Ethics committee reference number
IR.YUMS.REC.1395.195
Health conditions studied
1
Description of health condition studied
Complications of pelvic and ovarian laparascopy
ICD-10 code
T88.8, T88
ICD-10 code description
Other specified complications of surgical and medical care, not elsewhere classified, Complication of surgical and medical care, unspecified
Primary outcomes
1
Description
pain
Timepoint
24 hours pot operation
Method of measurement
visual scale
2
Description
nausea/vomiting
Timepoint
up to 48 hours post operation
Method of measurement
questionnaire
Secondary outcomes
1
Description
start gass passing time,start defication time
Timepoint
up to 72 hours postoperation
Method of measurement
check list
2
Description
pain
Timepoint
one week
Method of measurement
visual scale
3
Description
pain
Timepoint
one month
Method of measurement
visual scale
4
Description
need for analgesic
Timepoint
48 hours post operation
Method of measurement
miligram
Intervention groups
1
Description
in intervention groupintarperitoneal catheter will be inserted in cul de sac for 24 hours