Anal FistulaNCT04155905
Marsupialization of Anal Fistulotomy Wound Accelerates Healing and Decreases Post Operative Pain
A study testing fistulotomy and marsupialization of wound edges and fistulotomy in people with Anal Fistula, run by Zagazig University at 1 site in Egypt.
Trial summary
comparison between to groups of patients with simple anal fistula one group underwent sistulotomy the other underwent fistulotomy and marsupialization of the wound edges , the investigator tested the incidence of postoperative complications , time of wound healing , operative time Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anal Fistula
- What is being tested?
- fistulotomy and marsupialization of wound edges and fistulotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2018to 30 Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Simple non recurrent perianal fistula with ASA I and II.
Who cannot join
- secondary anal fistula,
- complex fistula,
- anal incontinence,
- previous anal surgery
- Any disease or drug that affects wound healing.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Fistulotomy Versus Fistulotomy With Marsupialization of Wound Edges in Simple Perianal Fistula, a Comparative Clinical Trial
comparison between to groups of patients with simple anal fistula one group underwent sistulotomy the other underwent fistulotomy and marsupialization of the wound edges , the investigator tested the incidence of postoperative complications , time of wound healing , operative time
Read the detailed description
This randomized controlled trial was carried in the period between May 2018 and April 2019, on 70 patients undergoing fistulotomy for treatment of simple perianal fistula. Patients were randomly allocated into two equal groups each 35 patients, group A; underwent fistulotomy without marsupialization of the edges of fistulotomy wound. And group B; underwent fistulotomy with marsupialization of the wound edges.
Patients included in this study are those suffering simple non recurrent perianal fistula with ASA I and II.
the investigator excluded patients with secondary anal fistula, complex fistula, anal incontinence, previous anal surgery and any disease or drug that affects wound healing.
All patients were subjected to thorough history taking and careful anal examination to assess the sphincter integrity, define the fistulous track and internal opening, endo anal ultrasound or magnetic resonance imaging was ordered when needed.
Fistulotomy was done under spinal anesthesia in the lithotomy position after skin preparation and patient draping; anal examination under anesthesia was done, identification of the internal opening carried out using palpation and inspection using proctoscope, injection of hydrogen peroxide in the external opening done if internal opening couldn't be defined easily, then the fistulous track was probed, it was laid open using diathermy, in group B the wounds was marsupialized by suturing the skin edges to the edges of the track floor using absorbable sutures (polygalactin) 3\0. Figures (1) and (2) shows the probed fistulous track and its' wound after marsupialization.
Postoperative non adherent dressing impregnated with local anesthetic cream was applied to the wound.
Nonsteroidal analgesic injection was given in injection form as per need. Follow up was carried out in outpatient clinic by the study surgeons, patients who agreed for participation in the study was instructed to visit the clinic every week for the first three post-operative months then every month for the next 3 months and lastly two visits after 3 and 6 months, the attending surgeon records follow up data including status of wound healing, anal continence and fistula recurrence.
An informed written consent was taken from all study participants. Randomization was done using computer program. The study was approved from institutional review board and the ethical committee from our university.
Demographic data, operative data, and postoperative data including pain, post-operative complications and time taken for complete wound healing were collected, properly analyzed using the paired t test and Z test using SPSS program.
- Conditions
- Anal Fistula
- Being tested
- fistulotomy and marsupialization of wound edges, fistulotomy
- Keywords
- simple anal fistula, 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 marsupialization of wound edgesProcedure or surgery
after defining the fistulous track it was laid open (marsupialization) was done together with marsupialization of the wound edge with vicryl 3\0 sutures
fistulotomyProcedure or surgery
after defining the fistulous track it was laid open (marsupialization)
| Study group | Role | What they receive |
|---|---|---|
| group A fistulotomy group | Active comparator | 35 patients with simple anal fistula subjected to fistulotomy Receives: Procedure: fistulotomy |
| group B marsupialization group | Active comparator | 35 patients with simple anal fistula subjected to fistulotomy and marsupialization of fistulotomy wound Receives: Procedure: fistulotomy and marsupialization of wound edges |
What is being measured
The primary outcome is the main question the study is designed to answer.
operative time in minutes
the time taken for completion of the procedure from fistulous track identification to the end of fistulotomy or marsupialization
Measured: intraoperative
postoperative pain using visual analogue scale
pain in the postoperative period
Measured: 1 week
postoperative complications measured by clinical examination and anal sphincter manometry
examination of the patient for fistula recurrence, history, clinical examination and anal sphincter manometry for anal incontinence
Measured: 1 year
wound healing time
time taken for wound to be completely healed
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 posted7 Nov 2019
- Study start1 May 2018
- Primary completion30 Apr 2019
- Study completion30 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies 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
- comparison between two groups of patients with simple anal fistula subjected to different types of treatment
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hazem Nour Abdellatif, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04155905
- Sponsor's protocol ID
- marsupialization anal fistula
- Status last verified
- Nov 2019
- First submitted
- 2 Nov 2019
- Last updated
- 12 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fistulotomy Versus Fistulotomy With Marsupialization of Wound Edges in Simple Perianal Fistula, a Comparative Clinical Trial
- ClinicalTrials.gov ID
- NCT04155905
- Acronym / sponsor ID
- marsupialization anal fistula
- Conditions
- Anal Fistula
- Keywords
- simple anal fistula, marsupialization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 May 2018 (actual)
- Primary completion
- 30 Apr 2019 (actual)
- Study completion
- 30 Apr 2019 (actual)
- First posted
- 7 Nov 2019 (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 to groups of patients with simple anal fistula one group underwent sistulotomy the other underwent fistulotomy and marsupialization of the wound edges , the investigator tested the incidence of postoperative complications , time of wound healing , operative time
Detailed description
This randomized controlled trial was carried in the period between May 2018 and April 2019, on 70 patients undergoing fistulotomy for treatment of simple perianal fistula. Patients were randomly allocated into two equal groups each 35 patients, group A; underwent fistulotomy without marsupialization of the edges of fistulotomy wound. And group B; underwent fistulotomy with marsupialization of the wound edges.
Patients included in this study are those suffering simple non recurrent perianal fistula with ASA I and II.
the investigator excluded patients with secondary anal fistula, complex fistula, anal incontinence, previous anal surgery and any disease or drug that affects wound healing.
All patients were subjected to thorough history taking and careful anal examination to assess the sphincter integrity, define the fistulous track and internal opening, endo anal ultrasound or magnetic resonance imaging was ordered when needed.
Fistulotomy was done under spinal anesthesia in the lithotomy position after skin preparation and patient draping; anal examination under anesthesia was done, identification of the internal opening carried out using palpation and inspection using proctoscope, injection of hydrogen peroxide in the external opening done if internal opening couldn't be defined easily, then the fistulous track was probed, it was laid open using diathermy, in group B the wounds was marsupialized by suturing the skin edges to the edges of the track floor using absorbable sutures (polygalactin) 3\0. Figures (1) and (2) shows the probed fistulous track and its' wound after marsupialization.
Postoperative non adherent dressing impregnated with local anesthetic cream was applied to the wound.
Nonsteroidal analgesic injection was given in injection form as per need. Follow up was carried out in outpatient clinic by the study surgeons, patients who agreed for participation in the study was instructed to visit the clinic every week for the first three post-operative months then every month for the next 3 months and lastly two visits after 3 and 6 months, the attending surgeon records follow up data including status of wound healing, anal continence and fistula recurrence.
An informed written consent was taken from all study participants. Randomization was done using computer program. The study was approved from institutional review board and the ethical committee from our university.
Demographic data, operative data, and postoperative data including pain, post-operative complications and time taken for complete wound healing were collected, properly analyzed using the paired t test and Z test using SPSS program.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- comparison between two groups of patients with simple anal fistula subjected to different types of treatment
| Arm | Type | Receives |
|---|---|---|
| group A fistulotomy group | Active comparator | Procedure: fistulotomy35 patients with simple anal fistula subjected to fistulotomy |
| group B marsupialization group | Active comparator | Procedure: fistulotomy and marsupialization of wound edges35 patients with simple anal fistula subjected to fistulotomy and marsupialization of fistulotomy wound |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Simple non recurrent perianal fistula with ASA I and II.
Key exclusion criteria (5 listed)
- secondary anal fistula,
- complex fistula,
- anal incontinence,
- previous anal surgery
- Any disease or drug that affects wound healing.
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 marsupialization of wound edgesafter defining the fistulous track it was laid open (marsupialization) was done together with marsupialization of the wound edge with vicryl 3\0 sutures | Procedure or surgery | group B marsupialization group |
| fistulotomyafter defining the fistulous track it was laid open (marsupialization) | Procedure or surgery | group A fistulotomy group |
Primary outcome
operative time in minutes
Time frame: intraoperative
the time taken for completion of the procedure from fistulous track identification to the end of fistulotomy or marsupialization
postoperative pain using visual analogue scale
Time frame: 1 week
pain in the postoperative period
postoperative complications measured by clinical examination and anal sphincter manometry
Time frame: 1 year
examination of the patient for fistula recurrence, history, clinical examination and anal sphincter manometry for anal incontinence
wound healing time
Time frame: 1 year
time taken for wound to be completely healed
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 12 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 of wound edges and fistulotomy in people with Anal Fistula, 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 12 Nov 2019. 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?
operative time in minutes (time frame: intraoperative). The study lists 4 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 12 Nov 2019.