Clinical trial NCT06353230: Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children
Official title: Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rectal Prolapse
Keywords: Injection Sclerotherapy
5% Phenol in Almond oil
15%Hypertonic saline
50% dextrose water
Rectal prolapse
Lead sponsor: King Edward Medical University
Sponsor class: OTHER
First posted: 2024-04-09
Enrollment: 93
Sex: ALL
Minimum age (years): 3
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Comparison of 5% phenol in almond oil, 15% hypertonic saline and 50% dextrose water for sclerotherapy treatment of rectal prolapse in children.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: Materials and Methods Study design: Randomized control trial. Setting: Paediatric surgery department, King Edward medical university, Mayo Hospital Lahore. Duration: Twelve months after approval of synopsis. Data collection procedure: After ethical approval, all the patients with rectal prolapse fulfilling inclusion criteria admitted. Routine history, thorough clinical examination and routine preoperative investigations was done. Patients were randomly allocated to group A, B or C using the lottery method. Group A patients were given injection sclerotherapy with 5% phenol in almond oil; Group B patients were given injection sclerotherapy with 15% hypertonic saline and group C patients were given injection sclerotherapy with 50% dextrose water solution. Under general anesthesia and patient in lithotomy position, 2-3 ml of sclerosing agent was injected into the submucosa at 3 sites around the circumference preferably at 3,6 and 9'o' clock positions about 2-3 cm above dentate line. The injection was performed under vision, using a speculum while LP needle was passed through the perianal skin. All patients were kept under observation during the hospital stay and discharged on same day and followed on week 1 and after 3 months for recurrence of rectal prolapse, fecal incontinence, perianal abscess and anal stenosis according to the operational definition.

Eligibility criteria: 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. -

Primary outcomes:
measure: Recurrence
timeFrame: 3 months
Secondary outcomes:
measure: fecal incontinence
timeFrame: 3 months
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: department of pediatric surgery King Edward Medical University
state: Punjab
Study officials:
References: