PainNCT05891314
The Effect of Botulinum Toxin Injection After Hemorrhoidectomy in Pain Control.
A study testing Botox Injectable Product and Internal sphincterotomy in people with Pain and Haemorriodectomy, run by Mansoura University at 1 site in Egypt.
Trial summary
Hemorrhoids are a common disease in the general population. Its prevalence is estimated to be 5-36 % and more prevalent in western countries . Half of people older than 50 years of age will suffer from hemorrhoids in a period of their life, of which only 5-10% will require surgical intervention while most of the… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Haemorriodectomy, Anal Sphincterotomy
- What is being tested?
- Botox Injectable Product and Internal sphincterotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 1 Feb 2023
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Both sexes,
- aged between 18 and 70 years old.
- Grade III and IV hemorrhoids.
- Those with failed conservative treatment.
Who cannot join
- surgically unfit patients due to multiple comorbidities,
- patients who need emergency operation for complicated hemorrhoids,
- patients with partial rectal prolapse
- patients with rectal varices due to portal hypertension
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Botulinum Toxin Injection After Hemorrhoidectomy in Pain Control: a Randomized Controlled Trial
Hemorrhoids are a common disease in the general population. Its prevalence is estimated to be 5-36 % and more prevalent in western countries . Half of people older than 50 years of age will suffer from hemorrhoids in a period of their life, of which only 5-10% will require surgical intervention while most of the remainders become asymptomatic and improved with the conservative treatment.
Conservative treatment in the form of diet modification as well as some medical treatment, is usually effective. On the other hand, a few patients require surgical intervention. Surgery is indicated for those not responding to conservative management, those with grade III, and grade IV hemorrhoids.
Read more
Surgical treatment is the only curative method for hemorrhoidal disease and indicated for advanced and complicated disease. The most radical operations with the best results are the Milligan-Morgan and Ferguson hemorrhoidectomy .
However, the major concern of hemorrhoidectomy is the post-operative pain that occurs in 20-40 % of patients and it is considered the main cause of refusing surgery. The cause of postoperative pain is multifactorial, including the type of anesthesia , hemorrhoidectomy technique. and spasm of the internal anal sphincter (IAS) that becomes exposed after hemorrhoidectomy. The spasm of the IAS is considered the target to relieve pain post operatively. Lateral internal sphincterotomy (LIS) is widely used as an adjunct to relieve pain post hemorrhoidectomy as it release the spasm of the sphincter and subsequently relieve pain. However, this procedure is not accepted by many surgeons due to its recorded complications as bleeding and mild degree of fecal incontinence, so its role following hemorrhoidectomy is still controversial.
On the other hand, the spasm of the anal sphincter can be abolished by injection of the botulinum toxin which acts on the acetylcholine receptor and consequently temporary muscle paralysis occurs that is followed by decreased pain and wound healing.
Our hypothesis is botulinum toxin relaxes the internal sphincter, so prevent its spasm and so reducing the pain and promoting wound healing more rapidly.
Read the detailed description
many procedures have been described to decrease the pain post hemorridectomy. Internal sphincterotomy Botox Injection giving strong analgesics
We aim to evaluate the efficacy of Botox and internal sphincterotomy in pain relief after hemorridectomy.
- Conditions
- Pain, Haemorriodectomy, Anal Sphincterotomy
- Being tested
- Botox Injectable Product, Internal sphincterotomy
- Keywords
- post hemorridectomy pain, sphincterotomy, botox injection
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botox Injectable ProductProcedure or surgery
Also called Botulonium toxin injection
one group will have botox injection in the internal sphincter
Internal sphincterotomyProcedure or surgery
Also called lateral internal sphincterotomy
this group will have internal sphincterotomy
| Study group | Role | What they receive |
|---|---|---|
| Botox injection post hemorridectomy | Active comparator | after piles excision this group will be subjected to botox injection in the internal sphincter Receives: Procedure: Botox Injectable Product; Procedure: Internal sphincterotomy |
| Hemorridectomy alone | No intervention | Just hemorridectomy without botox injection(control group) |
| Hemorridectomy plus internal sphincterotomy | Active comparator | after piles excision patients will undergo internal sphincterotomy Receives: Procedure: Botox Injectable Product; Procedure: Internal sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain
according to the visual analogue scale (VAS), which contain 10 degrees, the lower the degree , the lower the score this means less pain.
Measured: 2weeks
Secondary outcomes (1)
Time taken to return to daily activities in days.
return to daily activities without complaint
Measured: 4-6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start1 Dec 2021
- Primary completion30 Nov 2022
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmad Sakr, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891314
- Sponsor's protocol ID
- 5678
- Status last verified
- Jun 2023
- First submitted
- 26 May 2023
- Last updated
- 8 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Botulinum Toxin Injection After Hemorrhoidectomy in Pain Control: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05891314
- Acronym / sponsor ID
- 5678
- Conditions
- Pain, Haemorriodectomy, Anal Sphincterotomy
- Keywords
- post hemorridectomy pain, sphincterotomy, botox injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 6 Jun 2023 (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.
Hemorrhoids are a common disease in the general population. Its prevalence is estimated to be 5-36 % and more prevalent in western countries . Half of people older than 50 years of age will suffer from hemorrhoids in a period of their life, of which only 5-10% will require surgical intervention while most of the remainders become asymptomatic and improved with the conservative treatment.
Conservative treatment in the form of diet modification as well as some medical treatment, is usually effective. On the other hand, a few patients require surgical intervention. Surgery is indicated for those not responding to conservative management, those with grade III, and grade IV hemorrhoids.
Surgical treatment is the only curative method for hemorrhoidal disease and indicated for advanced and complicated disease. The most radical operations with the best results are the Milligan-Morgan and Ferguson hemorrhoidectomy .
However, the major concern of hemorrhoidectomy is the post-operative pain that occurs in 20-40 % of patients and it is considered the main cause of refusing surgery. The cause of postoperative pain is multifactorial, including the type of anesthesia , hemorrhoidectomy technique. and spasm of the internal anal sphincter (IAS) that becomes exposed after hemorrhoidectomy. The spasm of the IAS is considered the target to relieve pain post operatively. Lateral internal sphincterotomy (LIS) is widely used as an adjunct to relieve pain post hemorrhoidectomy as it release the spasm of the sphincter and subsequently relieve pain. However, this procedure is not accepted by many surgeons due to its recorded complications as bleeding and mild degree of fecal incontinence, so its role following hemorrhoidectomy is still controversial.
On the other hand, the spasm of the anal sphincter can be abolished by injection of the botulinum toxin which acts on the acetylcholine receptor and consequently temporary muscle paralysis occurs that is followed by decreased pain and wound healing.
Our hypothesis is botulinum toxin relaxes the internal sphincter, so prevent its spasm and so reducing the pain and promoting wound healing more rapidly.
Detailed description
many procedures have been described to decrease the pain post hemorridectomy. Internal sphincterotomy Botox Injection giving strong analgesics
We aim to evaluate the efficacy of Botox and internal sphincterotomy in pain relief after hemorridectomy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Botox injection post hemorridectomy | Active comparator | Procedure: Botox Injectable Product, Procedure: Internal sphincterotomyafter piles excision this group will be subjected to botox injection in the internal sphincter |
| Hemorridectomy alone | No intervention | –Just hemorridectomy without botox injection(control group) |
| Hemorridectomy plus internal sphincterotomy | Active comparator | Procedure: Botox Injectable Product, Procedure: Internal sphincterotomyafter piles excision patients will undergo internal sphincterotomy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Both sexes,
- aged between 18 and 70 years old.
- Grade III and IV hemorrhoids.
- Those with failed conservative treatment.
Key exclusion criteria (4 listed)
- surgically unfit patients due to multiple comorbidities,
- patients who need emergency operation for complicated hemorrhoids,
- patients with partial rectal prolapse
- patients with rectal varices due to portal hypertension
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 |
|---|---|---|
| Botox Injectable ProductAlso: Botulonium toxin injectionone group will have botox injection in the internal sphincter | Procedure or surgery | Botox injection post hemorridectomy, Hemorridectomy plus internal sphincterotomy |
| Internal sphincterotomyAlso: lateral internal sphincterotomythis group will have internal sphincterotomy | Procedure or surgery | Botox injection post hemorridectomy, Hemorridectomy plus internal sphincterotomy |
Primary outcome
Post-operative pain
Time frame: 2weeks
according to the visual analogue scale (VAS), which contain 10 degrees, the lower the degree , the lower the score this means less pain.
1 secondary outcome
Time taken to return to daily activities in days.
Time frame: 4-6weeks
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 8 Jun 2023.
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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 Botox Injectable Product and Internal sphincterotomy in people with Pain and Haemorriodectomy, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 4 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 8 Jun 2023. 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 Egypt. 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?
Post-operative pain (time frame: 2weeks). 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 8 Jun 2023.