Traumatic Anal Sphincteric Injury,Immediate vs Delayed RepairNCT05234931
Traumatic Anal Sphincteric Injury Immediate vs Delayed Repair
An observational study of Traumatic Anal Sphincteric Injury,Immediate vs Delayed Repair, run by Assiut University at 1 site in Egypt.
Trial summary
comparison between immediate and delayed repair regarding the need for another technique ,pain score or repositioning and need for repair. We aim to evaluate the effects of immediate and delayed repair regarding the morbidity and mortalit Objective 1: to assess the operative time and surgical field of both choices. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Traumatic Anal Sphincteric Injury,Immediate vs Delayed Repair
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2021to 1 Aug 2023
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: sample size was calculated using epidemiological information statistical package version7 Based on paramaters for cross sectional study
Who may be able to join
- both sex
- - Traumatic Patients Who Presented by anal Sphincteric Injury
- accept to participate in the study
Who cannot join
- Patient who arrest immediately when arrived trauma unit
- Obstetric Patients Who Presented by anal Sphincteric Injury
Trial locations and contacts
1 site in 1 country.
About this study
comparison between immediate and delayed repair regarding the need for another technique ,pain score or repositioning and need for repair. We aim to evaluate the effects of immediate and delayed repair regarding the morbidity and mortalit
- Objective 1: to assess the operative time and surgical field of both choices.
- Objective 2: to estimate post-operative pain using pain score, to measure hospital stay and to assess short -term post-operative complications
Read the detailed description
Many different secondary procedures have been described in an attempt to restore continence. These may be classified into indirect methods, where the divided sphincter is left unrepaired, and direct methods to repair the sphincter itself. Indirect techniques include construction of circum anal slings of striated muscle or fascia external sphincter reefing procedures" and the use of striated muscle grafts. Direct methods involve identification, mobilization, and suture of the ends of the divided sphincter. Thearliest 'attempts employed an end-to-end
What is being measured
The primary outcome is the main question the study is designed to answer.
comparison between immediate and delayed repair
Regarding the need for another technique ,pain score or repositioning and need for repair. We aim to evaluate the effects of immediate and delayed repair regarding the morbidity and mortalit
- Objective 1: to assess the operative time and surgical field of both choices.
- Objective 2: to estimate post-operative pain using pain score, to measure hospital stay and to assess short -term post-operative complications
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2022
- Study start1 Jan 2021
- Primary completion1 Apr 2023 (estimated)
- Study completion1 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Traumatic Anal Sphincteric Injury,Immediate vs Delayed RepairStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Youssef Mohamed Ali, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05234931
- Sponsor's protocol ID
- anal sphincteric injury
- Status last verified
- Feb 2022
- First submitted
- 30 Jan 2022
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Koscinski T, Marti MC. [Treatment of fecal incontinence by overlapping sphincteroplasty]. Wiad Lek. 1997;50 Suppl 1 Pt 1:151-4. Polish.
PubMed 9446343Barisic G, Krivokapic Z, Markovic V, Popovic M, Saranovic D, Marsavelska A. The role of overlapping sphincteroplasty in traumatic fecal incontinence. Acta Chir Iugosl. 2000;47(4 Suppl 1):37-41.
PubMed 11432241KRAATZ H. [PLASTIC SURGERY OF THE SPHINCTER FOR THE CONTROL OF INCONTINENCE]. Acta Chir Acad Sci Hung. 1964;5:219-23. No abstract available. German.
PubMed 14230622
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traumatic Anal Sphincteric Injury Immediate vs Delayed Repair
- ClinicalTrials.gov ID
- NCT05234931
- Acronym / sponsor ID
- anal sphincteric injury
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Apr 2023 (estimated)
- Study completion
- 1 Aug 2023 (estimated)
- First posted
- 10 Feb 2022 (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.
comparison between immediate and delayed repair regarding the need for another technique ,pain score or repositioning and need for repair. We aim to evaluate the effects of immediate and delayed repair regarding the morbidity and mortalit
- Objective 1: to assess the operative time and surgical field of both choices.
- Objective 2: to estimate post-operative pain using pain score, to measure hospital stay and to assess short -term post-operative complications
Detailed description
Many different secondary procedures have been described in an attempt to restore continence. These may be classified into indirect methods, where the divided sphincter is left unrepaired, and direct methods to repair the sphincter itself. Indirect techniques include construction of circum anal slings of striated muscle or fascia external sphincter reefing procedures" and the use of striated muscle grafts. Direct methods involve identification, mobilization, and suture of the ends of the divided sphincter. Thearliest 'attempts employed an end-to-end
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- sample size was calculated using epidemiological information statistical package version7 Based on paramaters for cross sectional study
Key inclusion criteria (3 listed)
- both sex
- - Traumatic Patients Who Presented by anal Sphincteric Injury
- accept to participate in the study
Key exclusion criteria (2 listed)
- Patient who arrest immediately when arrived trauma unit
- Obstetric Patients Who Presented by anal Sphincteric Injury
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
comparison between immediate and delayed repair
Time frame: Baseline
Regarding the need for another technique ,pain score or repositioning and need for repair. We aim to evaluate the effects of immediate and delayed repair regarding the morbidity and mortalit * Objective 1: to assess the operative time and surgical field of both choices. * Objective 2: to estimate post-operative pain using pain score, to measure hospital stay and to assess short -term post-operative complications
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Results publication: PubMed 9446343Koscinski T, Marti MC. [Treatment of fecal incontinence by overlapping sphincteroplasty]. Wiad Lek. 1997;50 Suppl 1 Pt 1:151-4. Polish.
- Results publication: PubMed 11432241Barisic G, Krivokapic Z, Markovic V, Popovic M, Saranovic D, Marsavelska A. The role of overlapping sphincteroplasty in traumatic fecal incontinence. Acta Chir Iugosl. 2000;47(4 Suppl 1):37-41.
- Results publication: PubMed 14230622KRAATZ H. [PLASTIC SURGERY OF THE SPHINCTER FOR THE CONTROL OF INCONTINENCE]. Acta Chir Acad Sci Hung. 1964;5:219-23. No abstract available. German.
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.
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 Traumatic Anal Sphincteric Injury,Immediate vs Delayed Repair, run by Assiut University at 1 site in Egypt.
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 3 inclusion and 2 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 10 Feb 2022. 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 Egypt. 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?
Contact Ahmed Mohamed Ali, Master (01122280895, ahmedbinyoussef1993@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
comparison between immediate and delayed repair (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05234931, which also lists 3 linked publications.
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 10 Feb 2022.