Protocol summary

Summary
The purpose of this study is to reduce pain after surgery for obesity.The patients with BMI> 40 or BMI> 35 with one comorbidity who are undergoing laparoscopic bypass surgery, are enrolled. Patients who convert to open or have activated drain, for any reason, so we must maintain the drain over 24 hours, are excluded from this study. We start this study in patients with morbid obesity who admitted in Rasool-e-Akram hospital. We select 50 patients. The intervention is that, At the end of the operation, when we have the negative result for air leak, in one group of patients Penrose drain was extracted from 5mm port in the left ant axillary line and in another groups through right midclavicular port. The Days after surgery leak test with methylene blue will performed.in Patients who haven’t leak, the drain will be removed completely in the same day and will discharge and Patients with positive tests excluded from the study. The questionnaire for patients, including pain localization, severity of pain, positional association, relation to drain extraction site and other ports, the quality of pain and, etc. in 24 hours, 1 week and 1 month after the operation was filled.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201202198588N3
Registration date: 2012-07-25, 1391/05/04
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2012-07-25, 1391/05/04
Registrant information
Name
Mohadeseh Pishgahroudsari
Name of organization / entity
Mnimally Invasive Surgery Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 6655 5447
Email address
research@lapsurg.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences.
Expected recruitment start date
2011-05-22, 1390/03/01
Expected recruitment end date
2012-06-21, 1391/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical trial examining the effect of the location of drains in abdominal pain after laparoscopy gastric bypass surgery Roux en y procedure in morbid obese
Public title
efficacy of Location of drains in abdominal pain after laparoscopic surgery for obesity.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Morbid obese patients with BMI over 40 or over 35 with one obese comorbidity such as metabolic disease, diabetes, HTN, HLP, Hyperbaric metabolic states;who are undergoing obesity surgery. Exclusion criteria: Patients who underwent laparoscopic surgery who converte to open؛Patients with activated drain for any reason(bleeding or Lake);The patients that forced us to maintain the drain for them over 24 hours.
Age
From 16 years old to 64 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Postal code
Approval date
2012-04-24, 1391/02/05
Ethics committee reference number
51526

Health conditions studied

1

Description of health condition studied
post operative abdominal pain
ICD-10 code
R10.4
ICD-10 code description
Other and unspecified abdominal pain

Primary outcomes

1

Description
Abdominal Pain
Timepoint
24 hours after intervention, one week after internetion,1 month after intervention.
Method of measurement
Visual Analogue Scale (VAS)

Secondary outcomes

1

Description
Drain site infection
Timepoint
one week after intervention
Method of measurement
Clinical examination

2

Description
Small bowel herniation through drain extraction site
Timepoint
24 hours after intervention, 1 week after intervention, 1 month after intervention
Method of measurement
Clinical examination

Intervention groups

1

Description
The drain will be extracted from the right side of the patients.
Category
Prevention

2

Description
The drain will be extracted from the left side of the patients.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Rasool-e-Akram Hospital
Full name of responsible person
Street address
Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Teran University of Medical Sciences.
Full name of responsible person
Dr.Akbar Fotouhi
Street address
Tehran University of Medical Sciences, Corner of Ghods St., Keshavarz Blvd., Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Teran University of Medical Sciences.
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
Minimally Invasive Surgery Research Center, Tehran University of Medical Sciences.
Full name of responsible person
Dr.Mohammad eidy
Position
Fellowship of laparoscopy
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
m_eidy1356@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical science، Minimally Invasive surgery of Research Center
Full name of responsible person
Dr.Mohammad eidy
Position
Follwship of laparoscopy
Other areas of specialty/work
Street address
Niyayesh Avenue, Sattarkhan Street, Rasool-e-Akram Hospital,Minimally Invasive surgery Research Center
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
m_eidy1356@yahoo.com,
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Minimally Invasive Surgery Research Center, Tehran University of Medical Sciences,Tehran,Iran.
Full name of responsible person
Mohadeseh pishgah-Roudsari
Position
Other areas of specialty/work
Street address
Minimally Invasive Surgery Research Center, Rasool-e-Akram Hospital, Niyayesh Ave, Sattarkhan St., Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 6655 5447
Fax
Email
mo.pishgah@gmail.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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