Protocol summary

Study aim
Comparison of patients' and plastic surgeons' satisfaction with the aesthetic results of various types of umbilical reconstruction methods in abdominal operations: Mercedes incision in reverse V
Design
This study consists of two groups, in one group, the Mercedes surgery method is used, and the other one, the inverted V surgery method is used. There were 30 participants in each group and the method of blinding was a single-blind method, where the participant did not know about the surgical procedure and the researcher knew what the procedure was and what the results were like.
Settings and conduct
The research is carried out in Hazrat Fatima Hospital. Photographs are taken of patients before and three months after the operation so that the results of the operation can be compared. The patients are followed up for three months, and after that,they are surveyed and the level of satisfaction in terms of shape, size, and natural appearance is checked by them and ten surgical professors.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Females over 18 years old and candidates for abdominoplasty surgery or breast reconstruction with abdominal flap/Exclusion criteria: no previous cosmetic surgery
Intervention groups
The first group in which the Mercedes method is used in such a way that a marking with methylene blue on the two lateral and upper wings between 0.5 and 1.0 cm from the central point is determined, forming the "Y" suggested in this technique. At this stage, the skin is cut above the Y mark. In the second group, in which the inverted V method is used, the arms of the cut are approximately 1.5 to 2 cm and an inverted V-shaped skin flap is raised at a predetermined, palpated umbilical point
Main outcome variables
The level of patient satisfaction; Complication rate; Aesthetic; The success rate of the operation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221111056465N1
Registration date: 2023-02-20, 1401/12/01
Registration timing: registered_while_recruiting

Last update: 2023-02-20, 1401/12/01
Update count: 0
Registration date
2023-02-20, 1401/12/01
Registrant information
Name
Vahab Rezaee
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8871 7272
Email address
vahab_rezaee@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-02-19, 1401/11/30
Expected recruitment end date
2023-08-21, 1402/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the aesthetic results of different types of umbilical cord reconstruction methods in abdominal operations: Mercedes incision versus inverted V incision in patients referred to Hazrat Fatemeh Hospital for umbilical cord reconstruction
Public title
Comparison of aesthetic results of different types of umbilical reconstruction methods in abdominal operations: Mercedes incision versus inverted V incision
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People over 18 years old A candidate for Abdominoplasty or Breast Reconstruction Surgery Female
Exclusion criteria:
Performing navel cosmetic surgery in the past
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
  • Participant
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization method is used in randomization. An envelope contains 60 pieces of paper on which groups A and B are written, and there are 30 pieces of each group in the envelope. Group A is assigned to the Mercedes surgery method and group B is assigned to the inverted V surgery method. Before performing the surgery, the surgeon takes out a paper from the envelope for each patient and the surgical method is selected based on the type of group
Blinding (investigator's opinion)
Single blinded
Blinding description
Before the operation, after choosing the type of operation, the surgeon and the researcher are aware of the type of operation, but after the surgery and subsequent examinations and data reporting, other residents of the center are used for examination, who are assigned a code for each type of operation. It is possible that only the researcher is aware of it
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Seyed JamalodinAsadabadi St.
City
Tehran
Province
Tehran
Postal code
1433933111
Approval date
2023-02-08, 1401/11/19
Ethics committee reference number
IR.IUMS.FMD.REC.1401.644

Health conditions studied

1

Description of health condition studied
Patients referred for abdominoplasty and breast reconstruction with abdominal flap
ICD-10 code
Z42.1
ICD-10 code description
Encounter for breast reconstruction following mastectomy

Primary outcomes

1

Description
aesthetics evaluation
Timepoint
Three months after surgery
Method of measurement
Observation and direct question from the patient

Secondary outcomes

1

Description
Umbilical necrosis
Timepoint
Three months after surgery
Method of measurement
Direct observation

2

Description
mbilical stenosis
Timepoint
Three months after surgery
Method of measurement
Direct observation

Intervention groups

1

Description
Intervention group: In this group, the Mercedes surgical method is used, where a marking with methylene blue on the two lateral and upper wings between 0.5 and 1.0 cm from the central point is determined, and they form the "Y" suggested in this technique. At this point, the skin is cut above the Y mark. To prevent umbilical stenosis, two "cuts" are removed from the side flaps of the Y to allow the umbilical suture to fit better
Category
Treatment - Surgery

2

Description
Control group: In this group, we use the inverted V surgery method, where the arms of the incision are approximately 1.5 to 2 cm and are separated by a distance of approximately 1.5 to 2.5 cm at the base. An inverted V-shaped skin flap is raised at a predetermined, palpated umbilical point
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Fatemeh Hospital
Full name of responsible person
Vahab Rezaee
Street address
Seyed Jamalodin Asadabadi St.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
vahab_rezaee@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hosseini Keyvani
Street address
Hemat Highway
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
keyvani.h@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Hazrate Fatemeh Hospital
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
Iran University of Medical Sciences
Full name of responsible person
Vahab Rezaee
Position
Specialist assistant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Seyed Jamalodin Asadabadi st.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
vahab_rezaee@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Reza Vaghardoost
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
plastic and reconstructive surgery
Street address
Seyed Jamalodin Asadabadi st.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
rezavaghar@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Vahab Rezaee
Position
Specialist assistant
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Seyed Jamalodin Asadabadi st.
City
Tehran
Province
Tehran
Postal code
1433933111
Phone
+98 21 8871 7272
Email
vahab_rezaee@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
Not applicable
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The written informed consent form will be provided to the participants after the procedure and will be included in the thesis. We have also published it in the Pajuheshyar system The data of the study also includes the results of the variables, including the level of satisfaction with the form of not causing complications
When the data will become available and for how long
The consent form will be placed in the attachments section after the thesis is printed. Also, the data of the participants is included in the thesis
To whom data/document is available
All people who have access to the full text of the thesis
Under which criteria data/document could be used
It can be modeled in similar studies
From where data/document is obtainable
Email to the general supervisor of the thesis Dr. Vahab Rezaee vahab_rezaee@yahoo.com
What processes are involved for a request to access data/document
After sending the email to the general supervisor, the thesis can be received within 1 week
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