Ignite Creation Date:
2024-05-06 @ 3:59 PM
Last Modification Date:
2024-10-26 @ 2:01 PM
Study NCT ID:
NCT04828889
Status:
UNKNOWN
Last Update Posted:
2021-04-02
First Post:
2021-03-24
Brief Title:
Effectiveness of Anal Enlargement by Dilators as a Therapeutic Physical Tool in Acute Anal Fissure
Sponsor:
Sheba Medical Center
Organization:
Sheba Medical Center
Study Overview
Official Title:
A Prospective Interventional Study to Examine the Effectiveness of Anal Enlargement by Dilators as a Therapeutic Physical Tool in Acute Anal Fissure
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 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
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
1 Anal examination by a proctologist to assess the presence and location of the the fissure
2 Fill out a clinical questionnaire that examines the sensation of pain burning itching and bleeding during defecation
3 Fill in the Psychometric properties of a questionnaire HEMO-FISSQoL to assess the effect of the fissure on daily functioning
4 Fill out a pain assessment questionnaire VAS
5 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
1 Disappearance of the fissure by proctologists examination
2 Disappearance of pain burning itching and bleeding during defecation
3 Improving the level of pain by using a VAS subjective assessment scale from 1-10
4 Improving the effect of the fissure on daily functioning by using the HEMO-FISSQoL
5 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
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
1 Anal examination by a proctologist to assess the presence and location of the the fissure
2 Fill out a clinical questionnaire that examines the sensation of pain burning itching and bleeding during defecation
3 Fill in the Psychometric properties of a questionnaire HEMO-FISSQoL to assess the effect of the fissure on daily functioning
4 Fill out a pain assessment questionnaire VAS
5 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
1 Disappearance of the fissure by proctologists examination
2 Disappearance of pain burning itching and bleeding during defecation
3 Improving the level of pain by using a VAS subjective assessment scale from 1-10
4 Improving the effect of the fissure on daily functioning by using the HEMO-FISSQoL
5 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None