Rectal Prolapse Clinical Trial
— ProlapseOfficial title:
Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children
NCT number | NCT06353230 |
Other study ID # | 0001 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 15, 2019 |
Est. completion date | April 13, 2021 |
Verified date | April 2024 |
Source | King Edward Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Introduction Patients with rectal prolapse are treated with injection sclerotherapy, which is the most often used first-line surgical technique. Injection sclerotherapy has a success rate of 90-100% in youngsters, according to certain studies. Objective To compare the outcome of injection sclerotherapy using 5% Phenol in almond oil, 15% hypertonic saline and 50% dextrose water in the treatment of rectal prolapse in children.
Status | Completed |
Enrollment | 93 |
Est. completion date | April 13, 2021 |
Est. primary completion date | October 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 13 Years |
Eligibility | Inclusion Criteria: • Patients with partial or complete rectal prolapse of either gender presenting to paediatric surgery department, Mayo Hospital Lahore, under 13 years of age. Exclusion Criteria: - Patients of rectal prolapse due to ulcerative colitis and crohn's disease documented in medical record. - Patients with previous history of surgery on pelvic floor documented in medical record. - Caudaequina syndrome, neural tube defects, Sacrococcygeal teratoma, Hirschsprung,s disease, congenitalmega colon and rectal polyps documented in medical record. - |
Country | Name | City | State |
---|---|---|---|
Pakistan | department of pediatric surgery King Edward Medical University | Lahore | Punjab |
Lead Sponsor | Collaborator |
---|---|
King Edward Medical University |
Pakistan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Recurrence | Re-appearance of signs and symptoms of rectal prolapse after remission will be labelled as | 3 months | |
Secondary | fecal incontinence | Kelly Score will be used to assess fecal incontinence. Kelly score includes 3 parameters; occurrence of accidents, soiling and anal sphincter action. Each parameter will be scored between 0-2 with total score of 6. Total score 5 or 6 will be labelled as good fecal continence, 3 or 4 score is fair and 0 to 2 score will be labelled as poor fecal continence | 3 months |
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