Safety and effectiveness of preoperative progressive pneumoperitoneum and botulinum toxin administration before abdominal wall reconstruction in patients with complex ventral hernia with loss of domain.
Determining safety and effectiveness of preoperative progressive pneumoperitoneum and botulinum toxin administration before abdominal wall reconstruction in patients with complex ventral hernia with loss of domain.
Design
This study is a phase 2 clinical trial without a control group that will be conducted on 10 patients.
Settings and conduct
Patients who were referred to Ghaem Hospital in Mashhad for abdominal wall hernia reconstruction will be included. The volume of the abdominal cavity and incisional hernia will be measured. There is no blinding in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Abdominal incisional hernia with loss of domain
Referring to abdominal wall reconstructive surgery.
Exclusion criteria:
Unwillingness to participate in the study.
A history of allergy to Botox.
Intervention groups
500 units of botulinum A (Masport, MasoonDarou Pharmaceutical Company, Iran) are mixed in 50 ml of normal saline. Under ultrasound guidance, it is injected in three layers of internal, external, and transverse oblique muscle in the abdominal wall and in 10 areas. The patient will be subjected to prep and drape in the same session for pneumoperitoneum. A small incision is made 5 cm from the herniated area, then the abdominal wall muscles are opened. Then, an 8-French feeding tube catheter is inserted into the peritoneum. Then the small incision is repaired, and the catheter is sutured to the abdominal wall. Finally, air injection starts in the amount of 1000 to 1500 ml in the first day. In the following days, the amount of air injection will be increased or decreased to such an extent that it does not cause discomfort, pain, or shortness of breath.
The procedure will be performed in one session. After 1 month, the abdominal cavity and incisional hernia volume will be measured.
Main outcome variables
The volume of the abdominal cavity,
Hernia volume
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230408057846N1
Registration date:2023-06-18, 1402/03/28
Registration timing:retrospective
Last update:2023-06-18, 1402/03/28
Update count:0
Registration date
2023-06-18, 1402/03/28
Registrant information
Name
Mohammad Reza Yousefi Rudsari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3833 2043
Email address
yousefirmr981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-05-22, 1402/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and effectiveness of preoperative progressive pneumoperitoneum and botulinum toxin administration before abdominal wall reconstruction in patients with complex ventral hernia with loss of domain.
Public title
Administration of pneumoperitoneum and botulinum toxin in abdominal wall reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Abdominal incisional hernia with loss of domain
Referring for abdominal wall reconstructive surgery
Exclusion criteria:
Unwillingness to participate in the study.
A history of allergy to Botox.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Reza Hospital Educational, Research and Treatment Center- Mashhad
Street address
Shahrak Danesh va Salamat, Shahid Fakouri Blvd. City. Mashhad.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Approval date
2023-02-06, 1401/11/17
Ethics committee reference number
IR.MUMS.IRH.REC.1401.067
Health conditions studied
1
Description of health condition studied
Large abdominal wall hernia with loss of domain
ICD-10 code
K46.9
ICD-10 code description
Unspecified abdominal hernia without obstruction or gangrene
Primary outcomes
1
Description
The volume of the abdominal cavity
Timepoint
Before and one month after botulinum and pneumoperitoneum injection
Method of measurement
Measurement of the the abdominal cavity volume by CT scan
2
Description
Hernia volume
Timepoint
Before and one month after botulinum and pneumoperitoneum injection
Method of measurement
Measurement of the the hernia volume by CT scan
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 500 units of botulinum A (Masport, MasoonDarou Pharmaceutical Company, Iran) are mixed in 50 ml of normal saline. Under ultrasound guidance, it is injected in three layers of internal, external, and transverse oblique muscle in the abdominal wall and in 10 areas. The patient will be subjected to prep and drape in the same session for pneumoperitoneum. A small incision is made 5 cm from the herniated area, then the abdominal wall muscles are opened. Then, an 8-French feeding tube catheter is inserted into the peritoneum. Then the small incision is repaired, and the catheter is sutured to the abdominal wall. Finally, air injection starts in the amount of 1000 to 1500 ml in the first day. In the following days, the amount of air injection will be increased or decreased to such an extent that it does not cause discomfort, pain, or shortness of breath. The procedure will be performed in one session. After 1 month, the abdominal cavity and incisional hernia volume will be measured.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghaem hospittal
Full name of responsible person
Ghodratollah Maddah
Street address
Parastar Street, Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3840 0000
Fax
Email
b.ghaem@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour Mobarhan
Street address
Mashhad University of Medical Sciences, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Fax
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Yousefi Rudsari
Position
Radiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Department of Radiology, Ghaem Hospital, Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
1708545
Phone
+98 51 3833 2043
Fax
Email
yousefirmr981@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Yousefi Rudsari
Position
Radiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Department of radiology of ,Ghaem Hospital , Ahmadabad Blvd , Mashhad, Razavi Khorasan Province
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3833 2043
Fax
Email
yousefirmr981@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Reza Yousefi Rudsari
Position
Radiology resident
Latest degree
Medical doctor
Other areas of specialty/work
Radiology
Street address
Department of Radiology, Ghaem Hospital, Ahmadabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
99199-91766
Phone
+98 51 3833 2043
Fax
Email
yousefirmr981@mums.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