Perianal FistulaNCT04722965
Treatment of Lower Transsphincteric Perianal Fistula: Fistulotomy With Marsupialization vs Open Wound
A study testing Fistulotomy with marsupialization and Fistulotomy with open wound in people with Perianal Fistula and Transsphincteric Anal Fistula, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
Trial summary
This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Perianal Fistula, Transsphincteric Anal Fistula
- What is being tested?
- Fistulotomy with marsupialization and Fistulotomy with open wound
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2021to 1 Jul 2023
- Phase
- Interventional
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Low transsphinteric perianal fistula, defined as a single tract in the lower third of the anal sphincter, confirmed by ultrasound and intraoperative evaluation.
- Ability to understand the study, to sign the consent and to complete the follow-up.
Who cannot join
- Under 18 years of age.
- Complex/recurrent fistula.
- Patients in which by clinical criteria is decided not to perform a fistulotomy.
- Anorectal malignancy.
- Crohn's desease.
- ASA IV or other contraindication for surgery.
- Inmunosuppressed patients or in treatment with steroids or cytotoxic drugs.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Consorci Sanitari Alt Penedes i Garraf
Sant Pere de Ribes, Barcelona, 08810
About this study
Official title: Randomized Clinical Trial for the Treatment of Lower Transsphincteric Perianal Fistula Using Fistulotomy With Marsupialization vs Open Wound
This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.
Read the detailed description
This is a multi-center triple blinded randomized clinical trial in which we'll compare two techniques for the treatment of simple low transsphincteric perianal fistulas. 40 patients will undergo a fistulotomy with marsupialization and 40 patients will undergo a fistulotomy with open wound. There will be an inclussion visit in which personal information will be recorded and the consent will be signed. Randomization will be done after inclusion, following a balanced blocks model. Information of the surgery technic won't be available for the investigator. The patients will have a journal in which they'll write their postoperative symptoms. Follow up will be done at weeks 2, 4 and 6 by the main investigator of each center. Data will be based in clinical examination, patient's diary and medical records. Statistical analysis of the primary outcome will be based in a superiority analysis using the Mantel-Cox test, or in case needed, a multivariate Cox regression analysis. The secondary outcomes will be analyzed by comparing times, percentages, mean or median with parametric or non parametric tests as it corresponds.
- Conditions
- Perianal Fistula, Transsphincteric Anal Fistula
- Being tested
- Fistulotomy with marsupialization, Fistulotomy with open wound
- Keywords
- low transsphincteric anal fistula, fistulotomy, marsupialization, perianal fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fistulotomy with marsupializationProcedure or surgery
A probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. Wound edges are sutured to the bottom of the fistula using interrupted sutures of vicryl 3-0 completing the marsupialization.
Fistulotomy with open woundProcedure or surgery
A probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. The wound is left open.
| Study group | Role | What they receive |
|---|---|---|
| Fistulotomy with marsupialization | Active comparator | 40 patients with a simple low transsphincteric anal fistula. A fistulotomy with marsupialization is performed. Receives: Procedure: Fistulotomy with marsupialization |
| Fistulotomy with open wound | Active comparator | 40 patients with a simple low transsphincteric anal fistula. A fistulotomy leaving the wound open is performed. Receives: Procedure: Fistulotomy with open wound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound healing time
Comparisson of the time it takes for the wound to not have areas without epithelium after the fistulotomy between the group with marsupialization and the open wound group.
Measured: 6 weeks
Secondary outcomes (10)
Postoperative pain
Maximum pain experienced by the patient in the postoperative period measured by the visual scale of pain.
Measured: 6 weeks
Return to daily activities
Days it takes the patients to return their daily activities (e.g. job).
Measured: 6 weeks
Operating time
Time the surgery takes since the assessment of the fistula tract to the beginning of dressing of the postoperative wound. It's measured in minutes.
Measured: 60 minutes
Hospitalization time
Days the patient has to stay admitted in the hospital.
Measured: 2 days
Bleeding of the postoperative wound
Number of bleeding episodes that require more changing of the dressings or assistance of a medical professional.
Measured: 6 weeks
Anal incontinence
Postoperative anal incontinence measured by the Browning and Parks incontinence scale: I: normal continence, II: Continent for solid and liquid stools but not for flatus, III: Continent for solid stools only, IV: Complete incontinence.
Measured: 6 weeks
Frequency of dressing change
Number of times per day a patient needs a dressing change
Measured: 6 weeks
Who performs the dressing change
Indicate who performs the dressing change: Patient, family member or medical professional.
Measured: 6 weeks
Postoperative wound infection
Presence of erythema, induration surrounding the wound or suppuration with or without an isolated pathogenic microorganism.
Measured: 6 weeks
Recurrence of the fistula
Reappearance of the fistula after complete healing of the surgical wound within the period of the study.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start1 Apr 2021
- Primary completion1 Feb 2023 (estimated)
- Study completion1 Jul 2023 (estimated)
Why it stopped: Feasibility problems to patients recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i Garraf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jessica Gonzales, MD, Principal investigator, CSAPG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722965
- Sponsor's protocol ID
- CSAPG-13
- Status last verified
- Mar 2024
- First submitted
- 21 Jan 2021
- Last updated
- 19 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial for the Treatment of Lower Transsphincteric Perianal Fistula Using Fistulotomy With Marsupialization vs Open Wound
- ClinicalTrials.gov ID
- NCT04722965
- Acronym / sponsor ID
- CSAPG-13
- Conditions
- Perianal Fistula, Transsphincteric Anal Fistula
- Keywords
- low transsphincteric anal fistula, fistulotomy, marsupialization, perianal fistula
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Feasibility problems to patients recruitment.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Consorci Sanitari de l'Alt Penedès i GarrafUniversity, hospital or other
- Study start
- 1 Apr 2021 (actual)
- Primary completion
- 1 Feb 2023 (estimated)
- Study completion
- 1 Jul 2023 (estimated)
- First posted
- 25 Jan 2021 (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.
This study will compare the results of marsupialization versus open wound after fistulotomy in low transsphincteric perianal fistulas.
Detailed description
This is a multi-center triple blinded randomized clinical trial in which we'll compare two techniques for the treatment of simple low transsphincteric perianal fistulas. 40 patients will undergo a fistulotomy with marsupialization and 40 patients will undergo a fistulotomy with open wound. There will be an inclussion visit in which personal information will be recorded and the consent will be signed. Randomization will be done after inclusion, following a balanced blocks model. Information of the surgery technic won't be available for the investigator. The patients will have a journal in which they'll write their postoperative symptoms. Follow up will be done at weeks 2, 4 and 6 by the main investigator of each center. Data will be based in clinical examination, patient's diary and medical records. Statistical analysis of the primary outcome will be based in a superiority analysis using the Mantel-Cox test, or in case needed, a multivariate Cox regression analysis. The secondary outcomes will be analyzed by comparing times, percentages, mean or median with parametric or non parametric tests as it corresponds.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fistulotomy with marsupialization | Active comparator | Procedure: Fistulotomy with marsupialization40 patients with a simple low transsphincteric anal fistula. A fistulotomy with marsupialization is performed. |
| Fistulotomy with open wound | Active comparator | Procedure: Fistulotomy with open wound40 patients with a simple low transsphincteric anal fistula. A fistulotomy leaving the wound open is performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Low transsphinteric perianal fistula, defined as a single tract in the lower third of the anal sphincter, confirmed by ultrasound and intraoperative evaluation.
- Ability to understand the study, to sign the consent and to complete the follow-up.
Key exclusion criteria (7 listed)
- Under 18 years of age.
- Complex/recurrent fistula.
- Patients in which by clinical criteria is decided not to perform a fistulotomy.
- Anorectal malignancy.
- Crohn's desease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fistulotomy with marsupializationA probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. Wound edges are sutured to the bottom of the fistula using interrupted sutures of vicryl 3-0 completing the marsupialization. | Procedure or surgery | Fistulotomy with marsupialization |
| Fistulotomy with open woundA probe is placed in the fistula tract and it's laid open over that probe. The tract is curretted. The wound is left open. | Procedure or surgery | Fistulotomy with open wound |
Primary outcome
Wound healing time
Time frame: 6 weeks
Comparisson of the time it takes for the wound to not have areas without epithelium after the fistulotomy between the group with marsupialization and the open wound group.
10 secondary outcomes
Postoperative pain
Time frame: 6 weeks
Return to daily activities
Time frame: 6 weeks
Operating time
Time frame: 60 minutes
Hospitalization time
Time frame: 2 days
Bleeding of the postoperative wound
Time frame: 6 weeks
Anal incontinence
Time frame: 6 weeks
Frequency of dressing change
Time frame: 6 weeks
Who performs the dressing change
Time frame: 6 weeks
Postoperative wound infection
Time frame: 6 weeks
Recurrence of the fistula
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2024.
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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.
Jessica Gonzales, MD principal investigator
CSAPG
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fistulotomy with marsupialization and Fistulotomy with open wound in people with Perianal Fistula and Transsphincteric Anal Fistula, run by Consorci Sanitari de l'Alt Penedès i Garraf at 1 site in Spain.
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 2 inclusion and 7 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: withdrawn, as of the sponsor's last update on 19 Mar 2024. 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 Spain. 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?
The study was withdrawn before enrolling participants, so there are no results.
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.
What does the primary outcome measure?
Wound healing time (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
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 19 Mar 2024.