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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.
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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anal dilators | Device | Anal sphincter training for relaxation |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Full recovery | The incidence of patients who achieved a full recovery of fissure at the end of treatment period | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Normal defecation | The incidence of patients who achieved normal defecation at the end of the treatment period | 4 weeks |
| Quality of life | The incidence of patients who achieved higher score of quality of life at the end of the treatment period |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miri Raveh | Contact | 0547473724 | miriavikar@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Dan Carter | Sheba Medical Center | Study Director |
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| ID | Term |
|---|---|
| D005401 | Fissure in Ano |
| ID | Term |
|---|---|
| D001004 | Anus Diseases |
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D000074722 | Lateral Internal Sphincterotomy |
| ID | Term |
|---|---|
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D000074432 | Sphincterotomy |
| D000074433 | Myotomy |
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Parallel groups: treatment group( with dilators) versus conservative treatment ( follow up)
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| lateral internal sphincterotomy |
| Procedure |
lateral internal sphincterotomy is a firmly established method for treating anal fissures. |
|
| 4 weeks |
| D004066 |
| Digestive System Diseases |