The aim of this study is the assessment of drain effect on postoperative pain in laparoscopic gynecological surgeries. This study is a randomized,non-placebo-controlled, single-center clinical trial. Inclusion criteria is all women aged 20- 55 years old who are candidates for laparoscopic cystectomy, total hysterectomy and myomectomy. In case of malignancies and any complication such as massive bleeding, bladder and genitourinary injuries during and after the surgery, patients will be excluded from the study. In intervention group (drain group), the surgery will be performed routinely. Then, a closed system of hemovaccum drain will be embedded from subsidiary truca and will be brought out the next day. In non drain group, just the laparoscopic surgery will be done routinely. The amount of abdominal and shoulder pain will be measured 12 and 24 hours after the surgery using visual analog scale. After the surgery, Panthazocin will be administered for patients with the pain number of more than 6 .If necessary, non steroid anti inflammatory drugs will be injected for those with pain number under 6.
Pain amount, using antibiotics and surgery complications will be compared in two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016022316161N2
Registration date:2016-03-02, 1394/12/12
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-03-02, 1394/12/12
Registrant information
Name
Reyhaneh Hosseini
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 7771 9922
Email address
r-hosseini@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University Of Medical Sciences
Expected recruitment start date
2016-03-03, 1394/12/13
Expected recruitment end date
2016-06-02, 1395/03/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment of drain effect on postoperative pain in laparoscopic gynecological surgery
Public title
Assessment of drain effect on pain after laparoscopic surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:age of 20- 55; candidates of laparoscopic cystectomy; total hysterectomy; myomectomy
Exclusion criteria: presence of malignancy in pathology results; surgery complications during and after the surgery such as massive bleeding; bladder injury; genitourinary injury
Age
From 20 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Tehran University of Medical Sciences
Street address
Qods St, Keshavarz Blvd
City
Tehran
Postal code
Approval date
2016-02-20, 1394/12/01
Ethics committee reference number
IR.TUMS.REC.1394.2012
Health conditions studied
1
Description of health condition studied
abdominal pain
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain
2
Description of health condition studied
shoulder pain
ICD-10 code
M75.9
ICD-10 code description
Shoulder lesion, unspecified
Primary outcomes
1
Description
abdominal and shoulder pain
Timepoint
6- 12 hours after surgery
Method of measurement
visual analog scale
Secondary outcomes
1
Description
fever
Timepoint
after surgery
Method of measurement
termometer
2
Description
using antibiotic
Timepoint
after surgery
Method of measurement
check list
Intervention groups
1
Description
In drain group, laparoscopic surgery is done routinely. Then a closed hemovaccum drain system is embedded from subsidiary truca and will be brought out the next day.
Category
Prevention
2
Description
In control group, just the laparoscopic surgery is performed.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Arash Women's Hospital
Full name of responsible person
Reyhaneh Hosseini
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran, Iran
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences , Deputy of Research
Full name of responsible person
Dr.Masood Yunesian
Street address
Qods St, Keshavarz Blvd
City
Tehran
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 , Deputy of Research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical sciences
Full name of responsible person
Reyhaneh Hosseini
Position
Assistant professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
r-hosseini@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical sciences
Full name of responsible person
Reyhaneh Hosseini
Position
Assistant professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Postal code
Phone
+98 21 7771 9922
Fax
Email
r-hosseini@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Arash Women 's Hospital , Tehran University of Medical sciences
Full name of responsible person
Reyhaneh Hosseini
Position
Assistant professor
Other areas of specialty/work
Street address
Arash Women 's Hospital, Rashid Ave, Resalat Highway, Tehranparse,Tehran.Iran
City
Tehran
Postal code
Phone
+98 212177719922
Fax
Email
r-hosseini@tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)