Evaluation of complications in two rectopexy techniques, mesh rectopexy and open posterior sacral rectopexy in children
Design
Two arm parallel group randomised trial with blinded researcher and outcome assessment
Simple randomization, 25 cases in each groups,
Settings and conduct
Two groups of children with refractory prolapse referred to Tabriz Children's hospital, the first group is case group (mesh rectopexy) and the other group is control group (open posterior sacral rectopexy). Patients and researchers are not aware of groups.
Participants/Inclusion and exclusion criteria
Exclusion criteria:
History of underlying disease such as cystic fibrosis, allergy to cow's milk and parasitic diseases such as Trichiura Trichuris.
History of previous anorectal surgery such as anoplasty and Hirschsprung's disease.
Other rectal diseases such as colitis and polyp and solitary rectal ulcer and colorectal tumors
Severe malnutrition.
Intervention groups
Intervention group 1: mesh rectopexy. Intervention group 2: open posterior sacral rectopexy
Main outcome variables
Surgical complications
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150124020767N2
Registration date:2020-02-18, 1398/11/29
Registration timing:retrospective
Last update:2020-02-18, 1398/11/29
Update count:0
Registration date
2020-02-18, 1398/11/29
Registrant information
Name
masoud jamshidi
Name of organization / entity
tabriz medical sciences university
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2257
Email address
jamshidim@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-03-20, 1395/01/01
Expected recruitment end date
2020-01-13, 1398/10/23
Actual recruitment start date
2016-03-20, 1395/01/01
Actual recruitment end date
2020-01-13, 1398/10/23
Trial completion date
2020-03-19, 1398/12/29
Scientific title
Evaluation of complications in two rectopexy techniques, mesh rectopexy and open posterior sacral rectopexy in children
Public title
evaluation of mesh rectopexy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Children with refractory prolapse (including constipation and other predispositions) after one year medical treatment.
Exclusion criteria:
History of underlying disease such as cystic fibrosis, allergy to cow's milk and parasitic diseases such as Trichiura Trichuris.
History of previous anorectal surgery such as anoplasty and Hirschsprung's disease
Other rectal diseases such as colitis and polyp and solitary rectal ulcer and colorectal tumors
Severe malnutrition.
Age
From 3 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Data analyser
Sample size
Target sample size:
25
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization.Patients receive a number, respectively, in the study, and the odd numbers place in the control group and the even numbers in the control group.
Blinding (investigator's opinion)
Double blinded
Blinding description
The patients, the researcher, and the analyzer are not aware of the groups
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Daneshgah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Approval date
2015-02-15, 1393/11/26
Ethics committee reference number
IR.TBZMED.REC.1395.553
Health conditions studied
1
Description of health condition studied
Rectal prolapse
ICD-10 code
K62.3
ICD-10 code description
Rectal prolapse
Primary outcomes
1
Description
Complication rate of prolapse repair
Timepoint
Complication rate after surgery
Method of measurement
Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Mesh rectopexy: Patients with refractory rectal prolapse to conservative management will be included in the study. In the case group, the mesh rectopexy procedure (using ribbon like sterile gauze) is performed. In this method, the perineal incision is made transversely as long as two centimeters between anus and coccyx. The longitudinal incision is then made in the pelvic diaphragm without damage to the muscles. A space is created in the retro-rectal area in the areolar tissue from anus to the sacrum promontory. This space opens and encompasses the posterior half of the rectum. Then the space is filled with about two meters of tape mesh and dressing is done. After a week the mesh will be removed and the wound will close spontaneously. The fibrosis created in this space causes the rectum to be fixed and not exit from anus. Post-operatively , patients will visit in the following day, the following week, and three months later, at the end of the first year. Findings and complications that were recorded in a questionnaire, compared with the control group. Statistical findings will be reviewed and published.
Category
Treatment - Surgery
2
Description
Control group: open posterior sacral rectopexy or standard method(Ashcraft technique): Patients with refractory rectal prolapse to conservative management will be included in the study. This procedure involves incising over sacrum bone and opening the pelvic space up to two centimeters from anus. The coccyx bone is removed. Rectum is separated from the sacrum. The meso-rectum is then destroyed. The rectum is fixed with a few sutures to the sacrum bone to prevent the rectum from descending and exiting from anus. The layers are closed in sequence and the operation is terminated. Post-operatively , patients will visit in the following day, the following week, and three months later, at the end of the first year. Findings and complications that were recorded in a questionnaire, compared with the control group. Statistical findings will be reviewed and published.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Children's Hospital
Full name of responsible person
Masoud Jamshidi
Street address
Shesglan St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2257
Email
Masoudjamshidi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Samiei.mohammad
Street address
Daneshgah St.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3335 7310
Email
research-vice@tbzmed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Jamshidi
Position
Assissted prof.
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Sheshglan st.
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Email
Masoudjamshidi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Jamshidi
Position
Assissted professor
Latest degree
Subspecialist
Other areas of specialty/work
pediatric surgery
Street address
Sheshglan
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
0098415262250
Email
Masoudjamshidi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Masoud Jamshidi
Position
Assissted professor
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Sheshglan
City
Tabriz
Province
East Azarbaijan
Postal code
5136735886
Phone
+98 41 3526 2250
Email
Masoudjamshidi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
starting 6 months after publication
To whom data/document is available
people working in academic institutions
Under which criteria data/document could be used
N/A
From where data/document is obtainable
Email
What processes are involved for a request to access data/document