Technical comparison of subcostal and intercostal flank skin incisions in open kidney surgeries
Design
This clinical trial will be conducted on 64 patients who are candidates for open kidney surgery with the mentioned entry and exit criteria. The studied samples will be selected as available and randomly divided into intervention groups. The samples are divided into two equal groups of intercostal flank incision (32 samples) and subcostal flank incision (32 samples) using the block randomization method.
Settings and conduct
The present study is a randomized and blinded clinical trial study that will be conducted on 64 patients undergoing open kidney surgery in the operating room of Shahid Beheshti Hospital and Bou Ali Sinai Hospital in Hamedan. The participants are randomly divided into two equal groups and the intervention will be performed on them and its consequences will be evaluated in the two groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Patients who are candidates for open kidney surgery
• Age between 18 and 55 years
• BMI between 18 and 30
Exit criteria:
• Longer incision 30 cm
• Re-operation with a cut on the previous incision
• Presence of abdominal wall hernia at the same time
• Diabetic participant
• Being pregnant if the person participating in the study is a woman
• History of peritoneal dialysis, previous hernia, taking immunosuppressive drugs, smoking and drug use, connective tissue diseases and disorders
• Having a surgical site infection after surgery
• Presence of ascites and abdominal distension after surgery
Hernia and bulge after surgery; Pain after surgery; The amount of painkillers received; Postoperative scar; Incision time; Time to suture the incision; Exposure of the operation field ; Quality of Life after surgery;
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230208057358N1
Registration date:2023-02-11, 1401/11/22
Registration timing:prospective
Last update:2023-02-11, 1401/11/22
Update count:0
Registration date
2023-02-11, 1401/11/22
Registrant information
Name
alireza abdi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 81 3426 3597
Email address
al.abdi@edu.umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-28, 1401/12/09
Expected recruitment end date
2023-08-31, 1402/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Technical comparison of intercostal flank and subcostal flank incisions in open kidney surgeries
Public title
Technical comparison of intercostal flank and subcostal flank incisions in open kidney surgeries
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Patients are candidates for open kidney surgery
Willingness and consent to participate in the study
Body mass index (BMI) between 18 and 30
Exclusion criteria:
Re-operation with a cut on the previous incision
Presence of abdominal wall hernia at the same time
The person participating in the study is diabetic
Being pregnant if the person participating in the study is a woman
History of chronic obstructive pulmonary disease
History of peritoneal dialysis
History of previous hernia
History of taking immunosuppressive drugs
History of smoking and drug use
History of connective tissue diseases and disorders
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
The studied samples will be selected as available and randomly divided into intervention groups. The samples are divided into two equal groups of intercostal flank incision (A) and subcostal flank incision (B) using the block randomization method. Our randomization tool in this study is random allocation software version 1, which is available at https://mahmoodsaghaei.tripod.com/Softwares/randalloc.html. The information required by the software, including the number of groups (2 groups), the name of each group (A=1, B=2), sample size (64 patients) and block size (4) were entered to generate a random sequence and based on that , 16 blocks of 4 including two groups A and B were randomly designed using the software.
In this study, we will use the concealment of random allocation for the purpose of concealment, which refers to the method used to perform a random sequence on the participants in the study, in such a way that the allocated group is not known before the allocation of the individual. In this method, each of the generated random sequences is recorded on a card and the cards will be placed in sealed opaque envelopes in order. In order to maintain a random sequence on the outer surface of the envelopes, numbering will be done in the same order. Finally, the lid of the letter envelopes will be glued and placed in a box. At the time of registration of participants, based on the order of entry of qualified participants into the study, one of the envelopes will be opened and the assigned group of that participant will be revealed.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will not know which surgical incision technique was used for them.
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 Sciences
Street address
Vice-chancellor for research and technology, In front of the Mardom park, Shahid Fahmideh steet, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838678
Approval date
2023-01-27, 1401/11/07
Ethics committee reference number
IR.UMSHA.REC.1401.937
Health conditions studied
1
Description of health condition studied
open kidney surgeries; flank hernia and bulge
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Hernia and bulge after surgery
Timepoint
At times 3 and 6 months after the operation
Method of measurement
Clinical examination by a specialist surgeon and medical imaging
2
Description
Pain after surgery
Timepoint
in 1 and 3 months after surgery
Method of measurement
Visual analog scale (VAS)
3
Description
The amount of painkillers received
Timepoint
At the time of discharge from the hospital
Method of measurement
Injection syringe (in milliliters)
4
Description
Surgical incision scar
Timepoint
At times 3 and 6 months after the operation
Method of measurement
Manchester scar scale
5
Description
Incision time
Timepoint
During surgery
Method of measurement
Digital clock (in minutes)
6
Description
Closure time
Timepoint
During surgery
Method of measurement
Digital clock (in minutes)
7
Description
Exposure of the operative site
Timepoint
Immediately after surgery
Method of measurement
Likert scale - scoring from one (suitable and sufficient exposure - highest satisfaction) to five (inappropriate and poor exposure - lowest satisfaction) -
8
Description
Quality of Life
Timepoint
Once before surgery and 1 and 3 months after surgery
Method of measurement
SF-36 questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Flank intercostal cut (lateral oblique cut between the 11th and 12th ribs from the rectus sheath to the sacrospinalis muscle)
Category
Treatment - Surgery
2
Description
Control group: Subcostal flank incision (diagonal flank incision that is made about 2 cm below the 12th rib from the rectus sheath to the Sacrospinalis muscle)
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Beheshti hospital
Full name of responsible person
Dr Behzad Imani
Street address
At the beginning of Eram Boulevard, Hamadan
City
Hamadan
Province
Hamadan
Postal code
65179-5-3371
Phone
+98 81 3838 0706
Email
shahidbeheshti@umsha.ac.ir
Web page address
http://beheshti.umsha.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Dr Behzad Imani
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh St., Pazhouhesh Square, Hamadan
City
Hamadan
Province
Hamadan
Postal code
6517838736
Phone
+98 81 3131 0000
Email
Webda@umsha.ac.ir
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
Alireza Abdi
Position
MSc student in Surgical technology
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No 110, Imam Khomeini St., Maryanaj
City
hamadan
Province
Hamadan
Postal code
6514144868
Phone
+98 81 3426 3597
Email
al.abdi@edu.umsha.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Abdi
Position
MSc student in Surgical technology
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No 110, Imam Khomeini St., Maryanaj
City
hamadan
Province
Hamadan
Postal code
6514144868
Phone
+98 81 3426 3597
Email
al.abdi@edu.umsha.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical Sciences
Full name of responsible person
Alireza Abdi
Position
MSc student in Surgical technology
Latest degree
Bachelor
Other areas of specialty/work
Others
Street address
No 110, Imam Khomeini St., Maryanaj
City
Hamadan
Province
Hamadan
Postal code
6514144868
Phone
+98 81 3426 3597
Email
al.abdi@edu.umsha.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is 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
Title and more details about the data/document
In this study, it will find part of the same data as the information related to the main outcome, follow-ups, and background and demographic information of the participants with the aim of researching the publication.
When the data will become available and for how long
No decision has been made yet
To whom data/document is available
The results of this study will be available for researchers working in academic and scientific institutions, surgeons, residents and nurses working in the clinical field.
Under which criteria data/document could be used
No decision has been made yet
From where data/document is obtainable
To receive documents or get guidance, people can access the email of the person responsible for this study at the address below.
Email address: al.abdi@edu.umsha.ac.ir
What processes are involved for a request to access data/document