Effectiveness of Anal Enlargement by Dilators as a Therapeutic Physical Tool in Acute Anal Fissure

NCT04828889 | Unknown

• 1 other identifier: SHEBA-20-7293-DC-CTIL
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Acute Anal Fissure

Keywords

Anal fissure, anal dilator, anal pain, physiotherapy

Outcome Measures

Primary Outcomes (1)

• Full recovery

  The incidence of patients who achieved a full recovery of fissure at the end of treatment period

  4 weeks

Secondary Outcomes (2)

• Normal defecation

  4 weeks

• Quality of life

  4 weeks

Study Arms (3)

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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.

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.

Procedure: lateral internal sphincterotomy

Interventions

Anal dilators DEVICE

Anal sphincter training for relaxation

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lateral internal sphincterotomy PROCEDURE

lateral internal sphincterotomy is a firmly established method for treating anal fissures.

surgery

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sheba Medical Center: lead

MeSH Terms

Conditions

Fissure in Ano

Interventions

Lateral Internal Sphincterotomy

Condition Hierarchy (Ancestors)

Anus Diseases; Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Digestive System Surgical Procedures; Surgical Procedures, Operative; Sphincterotomy; Myotomy

Study Officials

• Dan Carter

  Sheba Medical Center

  STUDY DIRECTOR

Central Study Contacts

Miri Raveh

CONTACT

0547473724; miriavikar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Parallel groups: treatment group( with dilators) versus conservative treatment ( follow up)

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: April 2, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: September 1, 2022
• Last Updated: April 2, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share