Fistula in AnoNCT04215718
Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula
A study testing fistulotomy and marsupialization and fistulectomy and wound closure in people with Fistula in Ano, run by Zagazig University at 1 site in Egypt.
Trial summary
comparison between fistulectomy wound closure and fistulotomw wound marsupialization in treatment of simple anal fistula Read more about this study
- Who is it for?
- Ages 18 days and older
- Conditions the study is for
- Fistula in Ano
- What is being tested?
- fistulotomy and marsupialization and fistulectomy and wound closure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2017to 31 Mar 2019
- 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 days and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients above 18 years diagnosed with simple non recurrent anal fistula.
Who cannot join
- Anorectal malignancy.
- Specific disease (Crohn's disease).
- ASA class III, VI and any contraindication for surgery
- Immunocompromized patients and those on steroid therapy or cytotoxic drugs.
- Perianal collection.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula, a Comparative Clinical Trial
comparison between fistulectomy wound closure and fistulotomw wound marsupialization in treatment of simple anal fistula
Read the detailed description
the investigators conducted this comparative clinical trial in the period between April 2017 and March 2019, on 92 patients with simple anal fistula, patients were randomly allocated into 2 groups, group I the fistulotomy group; 46 patients they underwent fistulotomy and marsupialization of wound edges. Group II, the fistulectomy group they underwent fistulectomy with closure of the wound.
Randomization was done using computer generated cards, the trial was approved by institutional review board (IRB) and the ethical committee of our hospitals, all study participants signed an informed written consent.
The condition of this trial is simple anal fistula defined as non-branched fistula confined to the lower third of the anal sphincter diagnosed by anorectal examination or MRI if needed, the primary outcomes are; the time taken for complete healing, fistula recurrence and anal incontinence diagnosed by Vaizey score patient's questionnaire. The secondary outcomes are local wound complications and postoperative pain calculated by visual analogue score (VAS). Study participants number was calculated through the IRB depending on the incidence of simple anal fistula in our locality.
inclusion criteria
- patients above 18 years diagnosed with simple non recurrent anal fistula. exclusion criteria:
- Anorectal malignancy.
- Specific disease (Crohn's disease).
- ASA class III, VI and any contraindication for surgery
- Immunocompromised patients and those on steroid therapy or cytotoxic drugs.
- Perianal collection. participants of this study were subjected to proper history taking and full clinical examination for diagnosis of the condition, detection of any associated disease and \ or exclusion factor. MRI was ordered if there is any doubt about diagnosis, preoperative investigations were ordered as per usual.
The procedure in both groups was carried out by the study surgeons, under general anesthesia in lithotomy position, anorectal examination was done to identify the internal and external openings, course of fistulous track and any side tracks if present. When the internal opening couldn't be identified the operator used methylene blue dye injection through the external opening. In fistulotomy group and after probing of the track it was let open by diathermy, its floor was curetted and the wound edges marsupialized by polygalactin (Vicryl) sutures 3\0.
In fistulectomy group and after probing, the fistulous track was excised by diathermy together with its internal and external openings, after hemostasis the wound was closed by polygalactin (Vicryl) sutures 3\0.
In both groups the wound was dressed with non-adhesive dressing, Nonsteroidal analgesics were given as per need and participants were discharged after 24 hours if there is no contraindication to do so.
After discharge study participants were encouraged for self-cleaning by antiseptic baths.
Follow up was carried out in the outpatient clinics by the study surgeons, the clinic visits were planed every week for 12 weeks then monthly for another three months, in each visit the investigator recorded the state of wound healing, anal continence, postoperative pain, any local wound complications, and any recurrence after complete healing in the follow up time.
Preoperative data, demographic data, operative time, intraoperative complications and follow up data were collected and properly analyzed using paired t test and Z tests in SPSS 22 program package.
- Conditions
- Fistula in Ano
- Being tested
- fistulotomy and marsupialization, fistulectomy and wound closure
- Keywords
- fistula in ano, fistulectomy wound closure, fistulotomy wound marsupialization
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fistulotomy and marsupializationProcedure or surgery
the anal fistula was laid open and the the wound edges was marsupialized using vicryle 3\0 sutures
fistulectomy and wound closureProcedure or surgery
anal fistula was excised with both openings and the wound was closed
| Study group | Role | What they receive |
|---|---|---|
| fistulotomy group | Active comparator | 46 patients with simple anal fistula underwent fistulotomy and marsupialization of wound edges Receives: Procedure: fistulotomy and marsupialization |
| fistulectomy group | Active comparator | 46 patients with simple anal fistula underwent fistulectomy and closure of the wound Receives: Procedure: fistulectomy and wound closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
healing time
time taken for complete epithelialization of the wound detected by clinical examination
Measured: 8 weeks
number of participants with recurrence of anal fistula
presence of anal fistula after complete wound healing detected by clinical examination
Measured: 6 months
number of participants with anal incontinence
inability to control stool or flatus diagnosed by Vaizey score questionaire
Measured: i months
Secondary outcomes (3)
number of participants with postoperative pain and its degree
degree of postoperative pain detected by visual analogue scale calculation
Measured: 1 week
number of participants with post operative complications
post operative complications as bleeding and wound infection detected by clinical examination
Measured: 1 week
operative time
time of the procedures calculated in minutes starting with the first incision to the start of wound dressing
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start1 Apr 2017
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fistula in AnoStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups of patients with simple anal fistula each one 46 patients the1st underwent fistulotomy with marsupialization of wound edges the second underwent fistulectomy and wound closure
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hazem Nour Abdellatif, Zagazig University
- Investigators
- hazem nour, MD, Principal investigator, zag university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04215718
- Sponsor's protocol ID
- anal fistula wound
- Status last verified
- Jan 2020
- First submitted
- 29 Dec 2019
- Last updated
- 7 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fistulotomy With Marsupialization Versus Fistulectomy With Wound Sutures in Simple Anal Fistula, a Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT04215718
- Acronym / sponsor ID
- anal fistula wound
- Conditions
- Fistula in Ano
- Keywords
- fistula in ano, fistulectomy wound closure, fistulotomy wound marsupialization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 2 Jan 2020 (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 fistulectomy wound closure and fistulotomw wound marsupialization in treatment of simple anal fistula
Detailed description
the investigators conducted this comparative clinical trial in the period between April 2017 and March 2019, on 92 patients with simple anal fistula, patients were randomly allocated into 2 groups, group I the fistulotomy group; 46 patients they underwent fistulotomy and marsupialization of wound edges. Group II, the fistulectomy group they underwent fistulectomy with closure of the wound.
Randomization was done using computer generated cards, the trial was approved by institutional review board (IRB) and the ethical committee of our hospitals, all study participants signed an informed written consent.
The condition of this trial is simple anal fistula defined as non-branched fistula confined to the lower third of the anal sphincter diagnosed by anorectal examination or MRI if needed, the primary outcomes are; the time taken for complete healing, fistula recurrence and anal incontinence diagnosed by Vaizey score patient's questionnaire. The secondary outcomes are local wound complications and postoperative pain calculated by visual analogue score (VAS). Study participants number was calculated through the IRB depending on the incidence of simple anal fistula in our locality.
inclusion criteria
- patients above 18 years diagnosed with simple non recurrent anal fistula. exclusion criteria:
- Anorectal malignancy.
- Specific disease (Crohn's disease).
- ASA class III, VI and any contraindication for surgery
- Immunocompromised patients and those on steroid therapy or cytotoxic drugs.
- Perianal collection. participants of this study were subjected to proper history taking and full clinical examination for diagnosis of the condition, detection of any associated disease and \ or exclusion factor. MRI was ordered if there is any doubt about diagnosis, preoperative investigations were ordered as per usual.
The procedure in both groups was carried out by the study surgeons, under general anesthesia in lithotomy position, anorectal examination was done to identify the internal and external openings, course of fistulous track and any side tracks if present. When the internal opening couldn't be identified the operator used methylene blue dye injection through the external opening. In fistulotomy group and after probing of the track it was let open by diathermy, its floor was curetted and the wound edges marsupialized by polygalactin (Vicryl) sutures 3\0.
In fistulectomy group and after probing, the fistulous track was excised by diathermy together with its internal and external openings, after hemostasis the wound was closed by polygalactin (Vicryl) sutures 3\0.
In both groups the wound was dressed with non-adhesive dressing, Nonsteroidal analgesics were given as per need and participants were discharged after 24 hours if there is no contraindication to do so.
After discharge study participants were encouraged for self-cleaning by antiseptic baths.
Follow up was carried out in the outpatient clinics by the study surgeons, the clinic visits were planed every week for 12 weeks then monthly for another three months, in each visit the investigator recorded the state of wound healing, anal continence, postoperative pain, any local wound complications, and any recurrence after complete healing in the follow up time.
Preoperative data, demographic data, operative time, intraoperative complications and follow up data were collected and properly analyzed using paired t test and Z tests in SPSS 22 program package.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 2 groups of patients with simple anal fistula each one 46 patients the1st underwent fistulotomy with marsupialization of wound edges the second underwent fistulectomy and wound closure
| Arm | Type | Receives |
|---|---|---|
| fistulotomy group | Active comparator | Procedure: fistulotomy and marsupialization46 patients with simple anal fistula underwent fistulotomy and marsupialization of wound edges |
| fistulectomy group | Active comparator | Procedure: fistulectomy and wound closure46 patients with simple anal fistula underwent fistulectomy and closure of the wound |
Who may qualify
- Ages
- 18 days and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- patients above 18 years diagnosed with simple non recurrent anal fistula.
Key exclusion criteria (5 listed)
- Anorectal malignancy.
- Specific disease (Crohn's disease).
- ASA class III, VI and any contraindication for surgery
- Immunocompromized patients and those on steroid therapy or cytotoxic drugs.
- Perianal collection.
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 and marsupializationthe anal fistula was laid open and the the wound edges was marsupialized using vicryle 3\0 sutures | Procedure or surgery | fistulotomy group |
| fistulectomy and wound closureanal fistula was excised with both openings and the wound was closed | Procedure or surgery | fistulectomy group |
Primary outcome
healing time
Time frame: 8 weeks
time taken for complete epithelialization of the wound detected by clinical examination
number of participants with recurrence of anal fistula
Time frame: 6 months
presence of anal fistula after complete wound healing detected by clinical examination
number of participants with anal incontinence
Time frame: i months
inability to control stool or flatus diagnosed by Vaizey score questionaire
3 secondary outcomes
number of participants with postoperative pain and its degree
Time frame: 1 week
number of participants with post operative complications
Time frame: 1 week
operative time
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2020.
- Individual participant dataSharing planned: No
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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.
hazem nour, MD principal investigator
zag university
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 and marsupialization and fistulectomy and wound closure in people with Fistula in Ano, run by Zagazig 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 7 Jan 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
healing time (time frame: 8 weeks). The study lists 3 primary outcomes in all. 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 7 Jan 2020.