Anal FissureNCT00980369
The Importance of Lateral Internal Sphincterotomy Incision: Parallel or Vertical
An observational study of Anal Fissure, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study is to determine effective incision type for the treatment of chronic anal fissures. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Anal Fissure
- How many people
- 52 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Oct 2007to Jan 2010
- Phase
- Observational
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Patients undergoing open lateral internal sphincterotomy for chronic anal fissure
Who cannot join
- Younger than 18 and older than 65 years of age, patients who had undergone no previous medical treatment, patients with a history of perianal interventions, patients with inflammatory bowel disease, diabetic patients, patients on steroids and immunosuppressives, patients with collagen tissue diseases, mentally retarded patients and patients with malignant disorders.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
SB Istanbul Education and Research Hospital
Istanbul
About this study
Official title: Incision Type for Lateral Internal Sphincterotomy
The purpose of this study is to determine effective incision type for the treatment of chronic anal fissures.
Read the detailed description
The lateral internal sphincterotomy (LIS) technique is considered the optimal surgical treatment for chronic anal fissures (CAFs); however, questions remain regarding the best technique. The present study investigated whether the type of anoderm incision (vertical or parallel to the anus) affected wound healing, wound-related complications, incontinence and recurrence rates in CAF patients undergoing open LIS.
- Conditions
- Anal Fissure
- Keywords
- Lateral internal sphincterotomy, Anal fissure, Surgical technique, Incision, Wound healing
- Medical subject headings
- Fissure in Ano, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Chronic anal fissures | Group A: with vertical incision Group B: with parallel incision | |
| Parallel incision, vertical insicion | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2009 (estimated)
- Study startOct 2007
- Primary completionMar 2008 (estimated)
- Study completionJan 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FissureStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- SB Istanbul Education and Research Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Feyzullah Ersoz, Study chair, Istanbul Education and Research Hospital, General surgery clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00980369
- Sponsor's protocol ID
- SBIstanbul
- Other IDs
- 2. General Surgery
- Status last verified
- Sep 2009
- First submitted
- 18 Sep 2009
- Last updated
- 21 Sep 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incision Type for Lateral Internal Sphincterotomy
- ClinicalTrials.gov ID
- NCT00980369
- Acronym / sponsor ID
- SBIstanbul
- Conditions
- Anal Fissure
- Keywords
- Lateral internal sphincterotomy, Anal fissure, Surgical technique, Incision, Wound healing
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 52 participants (actual)
- Lead sponsor
- SB Istanbul Education and Research HospitalUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Mar 2008 (estimated)
- Study completion
- Jan 2010 (estimated)
- First posted
- 21 Sep 2009 (estimated)
- 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 purpose of this study is to determine effective incision type for the treatment of chronic anal fissures.
Detailed description
The lateral internal sphincterotomy (LIS) technique is considered the optimal surgical treatment for chronic anal fissures (CAFs); however, questions remain regarding the best technique. The present study investigated whether the type of anoderm incision (vertical or parallel to the anus) affected wound healing, wound-related complications, incontinence and recurrence rates in CAF patients undergoing open LIS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chronic anal fissures | – | –Group A: with vertical incision Group B: with parallel incision |
| Parallel incision, vertical insicion | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (1 listed)
- Patients undergoing open lateral internal sphincterotomy for chronic anal fissure
Key exclusion criteria (1 listed)
- Younger than 18 and older than 65 years of age, patients who had undergone no previous medical treatment, patients with a history of perianal interventions, patients with inflammatory bowel disease, diabetic patients, patients on steroids and immunosuppressives, patients with collagen tissue diseases, mentally retarded patients and patients with malignant disorders.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2009.
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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.
Feyzullah Ersoz study chair
Istanbul Education and Research Hospital, General surgery clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anal Fissure, run by SB Istanbul Education and Research Hospital at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 21 Sep 2009. 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 Turkey (Türkiye). 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?
Results are not available in the source record.
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.
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 21 Sep 2009.