The aim of this study was to evaluate the results of injection of sclerosing agent around the anus to prevent rectal prolapse
Design
Clinical trial with control group, with parallel, non-blind, simple randomized groups, on 20 patients. Excel software rand function was used for randomization.
Settings and conduct
Patients are selected from the cases referred to the surgical clinic of the children's hospital. Intervention group: The rectal exam is done with a finger and a spoculum and then in three places at 3, 6, and 9 o'clock (1 cc per kilogram of body weight at 6 o'clock and 0.5 cc per kilogram at 3 and 9 o'clock) dextrose 50% is injected in sub-mucosa layer in 2-3 cm above the dantate line.
The control group is patients who continue non-surgical treatment for another 6 months and no procedure is performed on them. They are followed up with supportive treatments such as constipation treatment and wach and wait.
Participants/Inclusion and exclusion criteria
Including Criteria: 1. Patients with recurrent rectal prolapse after maintenance treatment for three to six months
2. Patients with idiopathic prolapse with a history of more than six months
Excluding Criteria:1. Patients with iatrogenic prolapse after pull-through surgery
2. Patients with rectal prolapse due to psychological issues
Intervention groups
Intervention group: The rectal exam is done with a finger and a spoculum and then in three places at 3, 6, and 9 o'clock (1 cc per kilogram of body weight at 6 o'clock and 0.5 cc per kilogram at 3 and 9 o'clock) dextrose 50% is injected in sub-mucosa layer in 2-3 cm above the dantate line.
The control group is patients who continue non-surgical treatment for another 6 months and no procedure is performed on them. They are followed up with supportive treatments such as constipation treatment and wach and wait.
Main outcome variables
Elimination of idiopathic rectal prolapse
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150114020663N6
Registration date:2021-09-25, 1400/07/03
Registration timing:prospective
Last update:2021-09-25, 1400/07/03
Update count:0
Registration date
2021-09-25, 1400/07/03
Registrant information
Name
Davoud Badebarin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3526 2257
Email address
badebarind@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-02, 1400/07/10
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Outcomes and complications of transanal sclerotherapy in children with rectal prolapse in Tabriz pediatric hospital
Public title
Perianal Sclerotherapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with recurrent rectal prolapse after maintenance treatment for three to six months
Exclusion criteria:
Patients with idiopathic prolapse with a history of less than six months
Patients with iatrogenic prolapse after pull-through surgery
Patients with rectal prolapse due to psychological issues
Patients with long intussusception removed from the rectum
Age
From 1 year old to 14 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to intervention and control groups. Patients are distributed in two groups (random sequence) using a table of random numbers. Patients are divided between the two groups by announcing the number of patients in the clinic. Odd numbers in one group and even numbers in the second group. Patients are selected in the clinic of Tabriz Children's Hospital
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences., Golgasht St., Azadi St
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2021-05-03, 1400/02/13
Ethics committee reference number
IR.TBZMED.REC.1400.145
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
Recurrence of rectal prolapse. Rectal bleeding
Timepoint
6 month
Method of measurement
Physical examination
Secondary outcomes
1
Description
Anal stenosis
Timepoint
Every three months
Method of measurement
Physical examination
Intervention groups
1
Description
Intervention group: Patients without the need for complete colon preparation with a normal saline enema and a recommendation to defecate once in the morning of surgery were transferred to the operating room and in the operating room and after general anesthesia in lithotomy position, first anus examination and The rectum is done with a finger and a spoculum and then in three places at 3, 6, and 9 o'clock (1 cc per kilogram of body weight at 6 o'clock and 0.5 cc per kilogram at 3 and 9 o'clock). Dextrose 50 The percentage is injected sub-mucosa 2-3 cm above the toothed line.
Category
Treatment - Drugs
2
Description
Control group: Supportive treatment: In this group, patients undergo supportive treatments such as treatment of constipation (laxatives) and control of the underlying cause of prolapse. Cases without constipation will have wach and wait for 6 months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Childeren Hospital
Full name of responsible person
Davoud Badebarin
Street address
ِDaneshgah Ave
City
Tabriz
Province
East Azarbaijan
Postal code
5165678691
Phone
+98 41 3526 2257
Email
badebarind@tbzmed.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Davoud badebarin
Street address
Tabriz children hospital(Farman Farmanian)
City
Tabriz
Province
East Azarbaijan
Postal code
5165789542
Phone
+98 41 3526 2257
Email
dbadebarin@gmail.com
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
Dr. Davoud Badebarin
Position
Pediatric Surgery Sub-specialist.
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Department of Surgery, Imam Reza Hospital, Daneshgah Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5165796444
Phone
+98 41 3334 1317
Fax
Email
badebarind@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Davoud Badebarin
Position
Pediatric Surgery Sub-specialist.
Latest degree
Subspecialist
Other areas of specialty/work
General Surgery
Street address
Department of Surgery, Imam Reza Hospital, Daneshgah Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5165796549
Phone
+98 41 3334 1317
Fax
Email
badebarind@tbzmed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Davoud Badebarin
Position
Pediatric Surgery Sub-specialist.
Latest degree
Subspecialist
Other areas of specialty/work
Pediatric Surgery
Street address
Department of Surgery, Imam Reza Hospital, Daneshgah Street, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5165789564
Phone
+98 41 3334 1317
Fax
Email
badebarind@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD