Rectal ProlapseProlapseNCT06353230
Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children
A study testing injection 5% phenol in almond oil, injection 15% hypertonic saline and injection 50% dextrose water in people with Rectal Prolapse, run by King Edward Medical University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 13 years
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- injection 5% phenol in almond oil, injection 15% hypertonic saline and injection 50% dextrose water
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Oct 2019to 13 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Patients with partial or complete rectal prolapse of either gender presenting to paediatric surgery department, Mayo Hospital Lahore, under 13 years of age.
Who cannot join
- 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. -
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
department of pediatric surgery King Edward Medical University
Lahore, Punjab Province, 54000
About this study
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.
Read the 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.
- Conditions
- Rectal Prolapse
- Being tested
- injection 5% phenol in almond oil, injection 15% hypertonic saline, injection 50% dextrose water
- Keywords
- Injection Sclerotherapy, 5% Phenol in Almond oil, 15%Hypertonic saline, 50% dextrose water, Rectal prolapse
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection 5% phenol in almond oilProcedure or surgery
Also called sclerotherapy wiyh 5% phenol in almond oil
Group A were given 5% phenol in almond oil
injection 15% hypertonic salineProcedure or surgery
Also called sclerotherapy with hypertonic saline
Group B were given hypertonic saline
injection 50% dextrose waterProcedure or surgery
Also called sclerotherapy with 50% dexrose water
group C were given 50% dextrose water
| Study group | Role | What they receive |
|---|---|---|
| Group A with 5% phenol in almond oil | Experimental | Group A patients with rectal prolapse were given injection sclerotherapy with 5% phenol in almond oil, Receives: Procedure: injection 5% phenol in almond oil; Procedure: injection 15% hypertonic saline; Procedure: injection 50% dextrose water |
| Group B with hypertonic saline | Active comparator | Group B with rectal prolapse were given injection sclerotherapy with 15% hypertonic saline Receives: Procedure: injection 5% phenol in almond oil; Procedure: injection 15% hypertonic saline; Procedure: injection 50% dextrose water |
| Group C with 50% Dextrose water | Active comparator | Group C with rectal prolapse were given injection sclerotherapy with 50% Dextrose water Receives: Procedure: injection 5% phenol in almond oil; Procedure: injection 15% hypertonic saline; Procedure: injection 50% dextrose water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Re-appearance of signs and symptoms of rectal prolapse after remission will be labelled as
Measured: 3 months
Secondary outcomes (1)
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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start15 Oct 2019
- Primary completion14 Oct 2020
- Study completion13 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Comparison of 5% phenol in almond oil, 15% hypertonic saline and 50% dextrose water for sclerotherapy treatment of rectal prolapse in children.
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Edward Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Sharif, King Edward Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06353230
- Sponsor's protocol ID
- 0001
- Acronym
- Prolapse
- Status last verified
- Apr 2024
- First submitted
- 31 Mar 2024
- Last updated
- 15 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Will be shared through personal request
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sclerotherapy Agents Used for Rectal Prolapse Treatment in Children
- ClinicalTrials.gov ID
- NCT06353230
- Acronym / sponsor ID
- Prolapse / 0001
- Conditions
- Rectal Prolapse
- Keywords
- Injection Sclerotherapy, 5% Phenol in Almond oil, 15%Hypertonic saline, 50% dextrose water, Rectal prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- King Edward Medical UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 14 Oct 2020 (actual)
- Study completion
- 13 Apr 2021 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Comparison of 5% phenol in almond oil, 15% hypertonic saline and 50% dextrose water for sclerotherapy treatment of rectal prolapse in children.
| Arm | Type | Receives |
|---|---|---|
| Group A with 5% phenol in almond oil | Experimental | Procedure: injection 5% phenol in almond oil, Procedure: injection 15% hypertonic saline, Procedure: injection 50% dextrose waterGroup A patients with rectal prolapse were given injection sclerotherapy with 5% phenol in almond oil, |
| Group B with hypertonic saline | Active comparator | Procedure: injection 5% phenol in almond oil, Procedure: injection 15% hypertonic saline, Procedure: injection 50% dextrose waterGroup B with rectal prolapse were given injection sclerotherapy with 15% hypertonic saline |
| Group C with 50% Dextrose water | Active comparator | Procedure: injection 5% phenol in almond oil, Procedure: injection 15% hypertonic saline, Procedure: injection 50% dextrose waterGroup C with rectal prolapse were given injection sclerotherapy with 50% Dextrose water |
Who may qualify
- Ages
- 3 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Patients with partial or complete rectal prolapse of either gender presenting to paediatric surgery department, Mayo Hospital Lahore, under 13 years of age.
Key exclusion criteria (3 listed)
- 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. -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| injection 5% phenol in almond oilAlso: sclerotherapy wiyh 5% phenol in almond oilGroup A were given 5% phenol in almond oil | Procedure or surgery | Group A with 5% phenol in almond oil, Group B with hypertonic saline, Group C with 50% Dextrose water |
| injection 15% hypertonic salineAlso: sclerotherapy with hypertonic salineGroup B were given hypertonic saline | Procedure or surgery | Group A with 5% phenol in almond oil, Group B with hypertonic saline, Group C with 50% Dextrose water |
| injection 50% dextrose waterAlso: sclerotherapy with 50% dexrose watergroup C were given 50% dextrose water | Procedure or surgery | Group A with 5% phenol in almond oil, Group B with hypertonic saline, Group C with 50% Dextrose water |
Primary outcome
Recurrence
Time frame: 3 months
Re-appearance of signs and symptoms of rectal prolapse after remission will be labelled as
1 secondary outcome
fecal incontinence
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2024.
- Individual participant dataSharing planned: No. Will be shared through personal request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing injection 5% phenol in almond oil, injection 15% hypertonic saline and injection 50% dextrose water in people with Rectal Prolapse, run by King Edward Medical University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2024.