Acute Anal FissureNCT04828889
Effectiveness of Anal Enlargement by Dilators as a Therapeutic Physical Tool in Acute Anal Fissure
A study testing Anal dilators and lateral internal sphincterotomy in people with Acute Anal Fissure, run by Sheba Medical Center.
Trial summary
The treatment of anal fissure is mainly surgical. There are complications to this treatment, including damage to the inner anal sphincter and the appearance of fecal incontinence. Anal dilators are devices that allow gradual enlargement of the anus. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Anal Fissure
- What is being tested?
- Anal dilators and lateral internal sphincterotomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2021to 1 Sep 2022
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 18-85 years
- Must have anal pain during bowel movements
- Must have acute posterior anal fissure
- Must have candidacy for surgery after failure of conservative treatment, or recurrence of the problem.
Who cannot join
- Concomitant anal pathology (anorectal fistulae,abscesses).
- Previous surgery on the pelvic floor.
- Inflammatory bowel disease
- Inability to sign consent to participate in the study
- Pregnancy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Interventional Study to Examine the Effectiveness of Anal Enlargement by Dilators as a Therapeutic Physical Tool in Acute Anal Fissure
The treatment of anal fissure is mainly surgical. There are complications to this treatment, including damage to the inner anal sphincter and the appearance of fecal incontinence.
Anal dilators are devices that allow gradual enlargement of the anus. To date, the use of these dilators has been in cases of sphincter scarring after a surgical procedure that has caused emptying difficulties. Only recently has the use of anal dilators been tried as a treatment for acute anal fissure.
The study is designated to examine whether healing of the fissure can be achieved by conservative treatment with anal extensions and obviating the need for surgical treatment.
Read the detailed description
Open prospective study. The study will include 75 patients (men and women) aged 18-85 years who are diagnosed with acute anal fissure and candidates for surgery after conservative treatment failure or recurrence of the problem.
During the waiting period for surgery, which lasted about a month, patients will be divided into three equal-sized groups at random (research, waiting and surgery).
Before the start of treatment and at the end of the waiting and surgery period, all patients will undergo:
- Anal examination by a proctologist to assess the presence and location of the the fissure
- Fill out a clinical questionnaire that examines the sensation of pain, burning, itching and bleeding during defecation
- Fill in the Psychometric properties of a questionnaire (HEMO-FISSQoL) to assess the effect of the fissure on daily functioning
- Fill out a pain assessment questionnaire (VAS)
- Fill out a quality of life questionnaire. Only patients with evidence of acute anal fissure in the physical examination will be included in the study.
The subjects in the study group will undergo a series of 4 treatments by 2 certified physiotherapists for pelvic floor treatment that will include instruction in self-use of anal dilators once a week for four weeks. The anal dilation will be performed using 'Dilatan'® anal dilators in varying sizes of 22, 23 and 27 mm. In the first week, a 20 mm dilator will be inserted twice a day for at least 10 minutes. In the second week, a 23 mm dilator will be inserted into the anus, twice a day for at least 10 minutes. In the last two weeks, a 27 mm dilator will be inserted twice a day for at least 10 minutes. To facilitate the insertion of the dilator, patients will use lubricating cream. At the end of each week, patients will meet with a pelvic floor physiotherapist to make sure that the insertion is done properly, that there are no side effects and that it is possible to move on to the next step.
The subjects in the waiting group will be able after a month to choose to undergo surgery or also receive treatment by dilators.
The subjects in the surgery group will undergo surgical treatment only. At the end of the waiting month, a comparison will be made between the indicators of the two groups: research and waiting, in order to evaluate the effectiveness of the treatment in the research group.
In the surgery group, these indices will be examined one month after the surgery
The indices to be examined are:
- Disappearance of the fissure by proctologist's examination
- Disappearance of pain, burning, itching and bleeding during defecation
- Improving the level of pain by using a VAS subjective assessment scale from 1-10
- Improving the effect of the fissure on daily functioning by using the HEMO-FISSQoL
- Improving the quality of life of the subjects by using the 36-Item Short Form Survey (SF-36)- Quality of Life Questionnaire Further assessments of the improvement in the quality of life of the subjects in the study group will be made three months and 6 months after the end of the experiment.
- Conditions
- Acute Anal Fissure
- Being tested
- Anal dilators, lateral internal sphincterotomy
- Keywords
- Anal fissure, anal dilator, anal pain, physiotherapy
- Medical subject headings
- Fissure in Ano
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anal dilatorsDevice
Anal sphincter training for relaxation
lateral internal sphincterotomyProcedure or surgery
lateral internal sphincterotomy is a firmly established method for treating anal fissures.
| Study group | Role | What they receive |
|---|---|---|
| research | Experimental | The subjects in the study group will undergo a series of 4 treatments by 2 certified physiotherapists for pelvic floor treatment that will include instruction in self-use of anal dilators once a week for four weeks. The anal dilation will be performed using Dilatan® anal dilators (Enterprises Sapimed, Alessandria) in varying sizes of 22, 23 and 27 mm. In the first week, a 20 mm dilator will be inserted twice a day for at least 10 minutes. In the second week, a 23 mm extender will be inserted into the anus, twice a day for at least 10 minutes. In the last two weeks, a 27 mm extender will be inserted twice a day for at least 10 minutes. To facilitate the insertion of the extender, patients will use lubricating cream. At the end of each week, patients will meet with a pelvic floor physiotherapist to make sure that the insertion is done properly, that there are no side effects and that it is possible to move on to the next step. Receives: Device: Anal dilators |
| waiting | No intervention | The subjects in the waiting group will be able after a month to choose to undergo surgery or also receive treatment by extenders. |
| surgery | Active comparator | The subjects in the surgery group will undergo surgical treatment only. Receives: Procedure: lateral internal sphincterotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Full recovery
The incidence of patients who achieved a full recovery of fissure at the end of treatment period
Measured: 4 weeks
Secondary outcomes (2)
Normal defecation
The incidence of patients who achieved normal defecation at the end of the treatment period
Measured: 4 weeks
Quality of life
The incidence of patients who achieved higher score of quality of life at the end of the treatment period
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start1 May 2021 (estimated)
- Primary completion1 May 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Anal FissureStudies of the same condition, open and under way.
- More trials run by Sheba Medical CenterThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Parallel groups: treatment group( with dilators) versus conservative treatment ( follow up)
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sheba Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Dan Carter, Study director, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04828889
- Sponsor's protocol ID
- SHEBA-20-7293-DC-CTIL
- Status last verified
- Mar 2021
- First submitted
- 24 Mar 2021
- Last updated
- 2 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Interventional Study to Examine the Effectiveness of Anal Enlargement by Dilators as a Therapeutic Physical Tool in Acute Anal Fissure
- ClinicalTrials.gov ID
- NCT04828889
- Acronym / sponsor ID
- SHEBA-20-7293-DC-CTIL
- Conditions
- Acute Anal Fissure
- Keywords
- Anal fissure, anal dilator, anal pain, physiotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Sheba Medical CenterOther government
- Study start
- 1 May 2021 (estimated)
- Primary completion
- 1 May 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 2 Apr 2021 (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.
The treatment of anal fissure is mainly surgical. There are complications to this treatment, including damage to the inner anal sphincter and the appearance of fecal incontinence.
Anal dilators are devices that allow gradual enlargement of the anus. To date, the use of these dilators has been in cases of sphincter scarring after a surgical procedure that has caused emptying difficulties. Only recently has the use of anal dilators been tried as a treatment for acute anal fissure.
The study is designated to examine whether healing of the fissure can be achieved by conservative treatment with anal extensions and obviating the need for surgical treatment.
Detailed description
Open prospective study. The study will include 75 patients (men and women) aged 18-85 years who are diagnosed with acute anal fissure and candidates for surgery after conservative treatment failure or recurrence of the problem.
During the waiting period for surgery, which lasted about a month, patients will be divided into three equal-sized groups at random (research, waiting and surgery).
Before the start of treatment and at the end of the waiting and surgery period, all patients will undergo:
- Anal examination by a proctologist to assess the presence and location of the the fissure
- Fill out a clinical questionnaire that examines the sensation of pain, burning, itching and bleeding during defecation
- Fill in the Psychometric properties of a questionnaire (HEMO-FISSQoL) to assess the effect of the fissure on daily functioning
- Fill out a pain assessment questionnaire (VAS)
- Fill out a quality of life questionnaire. Only patients with evidence of acute anal fissure in the physical examination will be included in the study.
The subjects in the study group will undergo a series of 4 treatments by 2 certified physiotherapists for pelvic floor treatment that will include instruction in self-use of anal dilators once a week for four weeks. The anal dilation will be performed using 'Dilatan'® anal dilators in varying sizes of 22, 23 and 27 mm. In the first week, a 20 mm dilator will be inserted twice a day for at least 10 minutes. In the second week, a 23 mm dilator will be inserted into the anus, twice a day for at least 10 minutes. In the last two weeks, a 27 mm dilator will be inserted twice a day for at least 10 minutes. To facilitate the insertion of the dilator, patients will use lubricating cream. At the end of each week, patients will meet with a pelvic floor physiotherapist to make sure that the insertion is done properly, that there are no side effects and that it is possible to move on to the next step.
The subjects in the waiting group will be able after a month to choose to undergo surgery or also receive treatment by dilators.
The subjects in the surgery group will undergo surgical treatment only. At the end of the waiting month, a comparison will be made between the indicators of the two groups: research and waiting, in order to evaluate the effectiveness of the treatment in the research group.
In the surgery group, these indices will be examined one month after the surgery
The indices to be examined are:
- Disappearance of the fissure by proctologist's examination
- Disappearance of pain, burning, itching and bleeding during defecation
- Improving the level of pain by using a VAS subjective assessment scale from 1-10
- Improving the effect of the fissure on daily functioning by using the HEMO-FISSQoL
- Improving the quality of life of the subjects by using the 36-Item Short Form Survey (SF-36)- Quality of Life Questionnaire Further assessments of the improvement in the quality of life of the subjects in the study group will be made three months and 6 months after the end of the experiment.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Parallel groups: treatment group( with dilators) versus conservative treatment ( follow up)
| Arm | Type | Receives |
|---|---|---|
| research | Experimental | Device: Anal dilatorsThe subjects in the study group will undergo a series of 4 treatments by 2 certified physiotherapists for pelvic floor treatment that will include instruction in self-use of anal dilators once a week for four weeks. The anal dilation will be performed using Dilatan® anal dilators (Enterprises Sapimed, Alessandria) in varying sizes of 22, 23 and 27 mm. In the first week, a 20 mm dilator will be inserted twice a day for at least 10 minutes. In the second week, a 23 mm extender will be inserted into the anus, twice a day for at least 10 minutes. In the last two weeks, a 27 mm extender will be inserted twice a day for at least 10 minutes. To facilitate the insertion of the extender, patients will use lubricating cream. At the end of each week, patients will meet with a pelvic floor physiotherapist to make sure that the insertion is done properly, that there are no side effects and that it is possible to move on to the next step. |
| waiting | No intervention | –The subjects in the waiting group will be able after a month to choose to undergo surgery or also receive treatment by extenders. |
| surgery | Active comparator | Procedure: lateral internal sphincterotomyThe subjects in the surgery group will undergo surgical treatment only. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age 18-85 years
- Must have anal pain during bowel movements
- Must have acute posterior anal fissure
- Must have candidacy for surgery after failure of conservative treatment, or recurrence of the problem.
Key exclusion criteria (5 listed)
- Concomitant anal pathology (anorectal fistulae,abscesses).
- Previous surgery on the pelvic floor.
- Inflammatory bowel disease
- Inability to sign consent to participate in the study
- Pregnancy
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 |
|---|---|---|
| Anal dilatorsAnal sphincter training for relaxation | Device | research |
| lateral internal sphincterotomylateral internal sphincterotomy is a firmly established method for treating anal fissures. | Procedure or surgery | surgery |
Primary outcome
Full recovery
Time frame: 4 weeks
The incidence of patients who achieved a full recovery of fissure at the end of treatment period
2 secondary outcomes
Normal defecation
Time frame: 4 weeks
Quality of life
Time frame: 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2021.
- Individual participant dataSharing planned: No
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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.
Dan Carter study director
Sheba Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Anal dilators and lateral internal sphincterotomy in people with Acute Anal Fissure, run by Sheba Medical Center.
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 5 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: status not confirmed, as of the sponsor's last update on 2 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Miri Raveh (0547473724, miriavikar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Full recovery (time frame: 4 weeks). 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 2 Apr 2021.