This study will be a double-blind, parallel clinical trial comparing two groups on 64 patients with pulmonary hydatid cysts at Al-Zahra Medical Center. Patients will be completely randomly divided into two groups using Excel software.
Settings and conduct
This study will be a double-blind, parallel clinical trial comparing two groups on 64 patients with pulmonary hydatid cysts at Al-Zahra Medical Center. Patients will be completely randomly divided into two groups using Excel software.
Participants/Inclusion and exclusion criteria
Inclusion criteria: All candidates for surgery with pulmonary hydatid cyst
Age between 18 and 75 years
Consent to participate in the study
Exclusion criteria: Concurrent pulmonary comorbidity such as asthma and COPD
Intervention groups
Individuals in the intervention group, after performing the standard surgical procedure, undergo capitonnage (after draining the cyst, the remaining cyst wall is sutured and collected), while the control group ends without capitonnage.
Main outcome variables
Air Leak
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221108056446N16
Registration date:2025-05-14, 1404/02/24
Registration timing:registered_while_recruiting
Last update:2025-05-14, 1404/02/24
Update count:0
Registration date
2025-05-14, 1404/02/24
Registrant information
Name
Mehdi Mahmoodkhani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 686 3733
Email address
mahmoodkhani@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-05-22, 1404/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of postoperative outcomes in lung hydatid cyst surgery in two methods with and without captonage
Public title
outcomes in lung hydatid cyst surgery in two methods with and without captonage
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All candidates for surgery with pulmonary hydatid cysts
Age between 18 and 75 years
Consent to participate in the study
Exclusion criteria:
Concurrent pulmonary comorbidities such as asthma and COPD
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
With the convenience sampling method, the referring individuals who are eligible for the study are randomly divided into two groups: case and control. In this study, the division of individuals is done using the four-way permutation block method. In this method, A represents the individual who receives the intervention and B represents the individual who is in the control group. Considering the four-way block, we give the AABB permutation code 0, the ABAB permutation code 1, ABBA code 2, BAAB code 3, BBAA code 4, and BABA codes 5 to 9. Then, using the random number table, we randomly select a starting point and then consider the numbers in rows or columns. Considering the order of the numbers in the table, we assign the corresponding permutation to each number we encounter. Finally, 64 people will be divided into two groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a randomized, double-blind clinical trial that will be conducted at Al-Zahra Medical Center, Isfahan University of Medical Sciences. In this study, patients and the statistical analyst will remain blind. In this way, the patient does not know about the suturing of the cyst wall, and the statistical analyst does not know which group of patients each set of data belongs to.
Patients will be divided into two groups using the four-way permutation block method in the rand function of Excel software.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medicine, Isfahan University of Medical Sciences
Street address
Hazar Jarib Street, Azadi Square
City
Esfahan
Province
Isfehan
Postal code
8174673461
Approval date
2025-05-05, 1404/02/15
Ethics committee reference number
IR.MUI.MED.REC.1404.061
Health conditions studied
1
Description of health condition studied
lung hydatid cyst
ICD-10 code
O01.0
ICD-10 code description
Classical hydatidiform mole
Primary outcomes
1
Description
Air Leak
Timepoint
Three months after surgery
Method of measurement
Clinical examination
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: After the standard surgical procedure, patients undergo capitonnage (after the cyst is drained, the remaining cyst wall is sutured and collected).
Category
Treatment - Surgery
2
Description
Control group: Patients do not undergo capitonnage after the standard surgical procedure, so the cyst wall is not sutured.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Al-zahra Hospital
Full name of responsible person
Hamid Talebzadeh
Street address
Al-zahra Hospital
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 314 0640
Email
talebzadeh.h@med.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Gholamreza Asgari
Street address
Al-zahra Hospital, Sofeh
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3668 0048
Email
mui@mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
10
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
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Talebzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra Hospital, Soffe Street
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 314 0640
Email
talebzadeh.h@med.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Hamid Talebzadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra Hospital, Soffe Street
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 314 0640
Email
talebzadeh.h@med.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Pourya Akbari Nasab
Position
Resident
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Al-Zahra Hospital, Soffe Street
City
Esfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 913 314 0640
Email
talebzadeh.h@med.mui.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
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