Rectal Prolapse
Conditions
Keywords
Injection Sclerotherapy, 5% Phenol in Almond oil, 15%Hypertonic saline, 50% dextrose water, Rectal prolapse
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.
Interventions
PROCEDUREinjection 5% phenol in almond oil
Group A were given 5% phenol in almond oil
PROCEDUREinjection 15% hypertonic saline
Group B were given hypertonic saline
PROCEDUREinjection 50% dextrose water
group C were given 50% dextrose water
Sponsors
King Edward Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Randomly allocated groupA,B or C by computer generated lottery method.and participants ,care provider and outcome assessor were kept blind by removing the drug name from injection vial
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.
Eligibility
Sex/Gender
ALL
Age
3 Years to 13 Years
Healthy volunteers
No
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. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recurrence | 3 months | Re-appearance of signs and symptoms of rectal prolapse after remission will be labelled as |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| fecal incontinence | 3 months | 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 |
Countries
Pakistan
Outcome results
None listed