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Comparison of open drainage, closed drainage and absence of drainage on abdominal collection in cholecystectomy patients

Protocol summary

Study aim
The aim of the study will be to compare open drainage, closed drainage and absence of drainage on abdominal collection post-cholecystectomy
Design
Randomized clinical trial with control group, with a parallel group design of 150 patients, phase 3. The rand function of Excel software will be used for randomization.
Settings and conduct
This study will be conducted as a randomized clinical trial with a control group and without blinding in Besat Hospital in Hamdan, on patients undergoing cholecystectomy.In this study, after cholecystectomy , in order to discharge the blood and secretions from the surgical site, one group will have an open drainage, the second group will have a closed drainage, and the third group will have no drainage at the surgical site. One week after the surgery, the abdominal area will be checked for collection by ultrasound.
Participants/Inclusion and exclusion criteria
The participants will be patients candidates for cholecystectomy. The age of 18 to 80 years is the conditions for entering the study and having a history of abdominal surgery, heart disease, heart transplant and taking immunosuppressive drugs are the conditions of not entering the study.
Intervention groups
Three parallel intervention groups, the first and second group after surgery, will be repaired at the cholecystectomy site with a drainage. Open drain will be used in the first group and closed drain will be used in the second group. In the third group, the operation was done in a standard method and the operation site will be repaired without inserting a drainage
Main outcome variables
Post cholecystectomy abdominal collection

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20151123025202N30
Registration date: 2023-05-15, 1402/02/25
Registration timing: prospective

Last update: 2023-05-15, 1402/02/25
Update count: 0
Registration date
2023-05-15, 1402/02/25
Registrant information
Name
Abbas Moradi
Name of organization / entity
Hamedan University of Medical Of Science
Country
Iran (Islamic Republic of)
Phone
+98 81 3838 0097
Email address
a.moradi@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2024-01-20, 1402/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of open drainage, closed drainage and absence of drainage on abdominal collection in cholecystectomy patients
Public title
Effect of drainage on the intra-abdominal of cholecystectomy collection
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients candidate for cholecystectomy
Exclusion criteria:
History of abdominal surgery Patients with congenital and acquired immune deficiency
Age
From 18 years old to 80 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
We made 150 cards and write letters OD on 50 cards for Open Drainage, CD on 50 cards for closed Drainage and on the other 50 letters ND for No Drainage group. Then put them inside the envelope with aluminum wrap and put in a box. At the time of patient arrival, one of the envelopes randomly will be selected and open it, based on selected letter patients will be assigned to open drainage, closed drainage or no drainage groups.
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 Hamadan University of Medical Science
Street address
ُShahid Fahmideh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838697
Approval date
2023-05-06, 1402/02/16
Ethics committee reference number
IR.UMSHA.REC.1402.105

Health conditions studied

1

Description of health condition studied
Acute cholecystitis
ICD-10 code
K80.0
ICD-10 code description
Calculus of gallbladder with acute cholecystitis

Primary outcomes

1

Description
Abdominal collection
Timepoint
One week post-surgery
Method of measurement
Abdominal ultrasound

Secondary outcomes

1

Description
Pain Severity
Timepoint
24 hours post-surgery
Method of measurement
With Visual Analogue Scale

Intervention groups

1

Description
Intervention group: This group will be operated under open drain. For this purpose, after the surgery , a tube, which is closed on both sides, is placed on one side of the surgical site, and the other side of the tube is outside to discharge the blood and secretions from the surgical site to the outside of the body.
Category
Treatment - Devices

2

Description
Intervention group: The second group will be under a closed drain. A tube that is open on one side and is placed in the surgical site. The other side of the tube has a bag to collect blood and secretions from the surgical site.
Category
Treatment - Devices

3

Description
Control group: In this group, the surgical site will be sutured without inserting a drain .
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Dr Roholla Hosseini
Street address
Shahid Beheshti Blvd, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6514845411
Phone
+98 81 3264 0030
Fax
+98 81 3265 1515
Email
Besat@umsha.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Reza Shokohi
Street address
Shahid Fahmide Ave, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838677
Phone
+98 81 3838 0717
Fax
+98 81 3838 0130
Email
vc_research@umsha.ac.ir
Web page address
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamedan 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
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Medical school, Shahid Fahmideh Ave, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Medical School, Shahid Fahmideh Aven, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Abbas Moradi
Position
MSc in epidemiology/ Comunity Medicine MS
Latest degree
Master
Other areas of specialty/work
Epidemiology
Street address
Medical School, Shahid Fahmideh Ave, Hamadan, Iran
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3838 0557
Fax
Email
a.moradi@umsha.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
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
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