Comparison the classic surgical cut and the intra-umbilical cut in the umbilical surgeries in terms of cutting length and surgery adverse effects
Design
Phase 2-3 randomized clinical trial with parallel groups which will be conducted on 60 patient with umbilical disorders
Settings and conduct
This study will be conducted with the aim of comparison the classic surgical cut and the intra-umbilical cut in the umbilical surgeries in terms of cutting length and surgery adverse effects in 60 patients with umbilical disorders attending Ali Ebne Abitaleb hospital in Zahedan city. After inclusion in the study, the patients will be assigned into two groups; classic surgical cut group and intra-umbilical cut group.
In the classic cut group a 8-12 cm vertical curved incision is given below the umbilicus and the skin and fat tissue is pulled away until the fascia is exposed and the hernia sac is explored and resected and in the intra-umbilical cut group a 6 cm incision is given on the hernia sac in the umbilicus and the skin and fat tissue is pulled away and the hernia sac is freed and resected.
After the surgery, the surgical cut size will be measured by a meter in both groups and will be compared together.
Participants/Inclusion and exclusion criteria
Inclusion criterion: having umbilical hernia or other umbilical disorders needing surgery
Exclusion criteria: history of umbilical surgery; having underlying diseases such as diabetes
Intervention groups
Classic cut group: a 8-12 cm vertical curved incision is given below the umbilicus and the skin and fat tissue is pulled away until the fascia is exposed and the hernia sac is explored and resected.
Intra-umbilical cut group: a 6 cm incision is given on the hernia sac in the umbilicus and the skin and fat tissue is pulled away and the hernia sac is freed and resected.
Main outcome variables
Surgical cut size measured by a meter
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210124050125N1
Registration date:2021-03-17, 1399/12/27
Registration timing:registered_while_recruiting
Last update:2021-03-17, 1399/12/27
Update count:0
Registration date
2021-03-17, 1399/12/27
Registrant information
Name
Alireza Khazaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 54 3329 5715
Email address
dr.khazaei@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-02-08, 1399/11/20
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the classic surgical cut and the intra-umbilical cut in the umbilical surgeries in terms of cutting length and surgery adverse effects
Public title
Comparison the classic surgical cut and the intra-umbilical cut in the umbilical surgeries in terms of cutting length and surgery adverse effects
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having umbilical hernia or other umbilical disorders needing surgery
Exclusion criteria:
History of umbilical surgery
Having underlying diseases such as diabetes
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
The patients are randomly assigned into two groups (classic surgical cut group and intra-umbilical cut group) using a random number table. A random number table containing unrepeated numbers between 1 and 60 is selected and the reading is started from the left. If the number is odd the patient is assigned into classic surgical cut group and if the number is even the patient is assigned into intra-umbilical cut group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The person analyzing the data won't be aware of the patients assignment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Zahedan University of Medical Sciences
Street address
Zahedan University of Medical Sciences and Health Services campus, Khalije Fars Blv, Doctor Hesabi Sq, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Approval date
2021-01-10, 1399/10/21
Ethics committee reference number
IR.ZAUMS.REC.1399.458
Health conditions studied
1
Description of health condition studied
Umbilical hernia
ICD-10 code
K42
ICD-10 code description
Umbilical hernia
Primary outcomes
1
Description
Surgical cut size
Timepoint
After the surgery
Method of measurement
By meter
2
Description
Surgery adverse effects including infection and scarring of the surgery site
Timepoint
Ten days after surgery
Method of measurement
By inspecting the surgery site
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: classic cut group: a 8-12 cm vertical curved incision is given below the umbilicus and the skin and fat tissue is pulled away until the fascia is exposed and the hernia sac is explored and resected.
Category
Treatment - Surgery
2
Description
Intervention group: intra-umbilical cut group: a 6 cm incision is given on the hernia sac in the umbilicus and the skin and fat tissue is pulled away and the hernia sac is freed and resected.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebne Abi Taleb Hospital
Full name of responsible person
Alireza Khazaei
Street address
Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916789547
Phone
+98 54 3329 5715
Email
ayubabedi48@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
Vice chancellor for research, Zahedan University of Medical Sciences, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5721
Email
Dr.Taheri@zaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Khazaei
Position
General surgery associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ebne Abi Taleb Hospital ,Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Fax
Email
dr.khazaei@zaums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Khazaei
Position
General surgery associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ebne Abi Taleb Hospital ,Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Fax
Email
dr.khazaei@zaums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Alireza Khazaei
Position
General surgery associate professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Ali Ebne Abi Taleb Hospital ,Khalije Fars Blv, Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3329 5715
Fax
Email
dr.khazaei@zaums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available