Transsphincteric Anal FistulaprofessorNCT04351074
Ligation of Intersphincteric Track (LIFT) Versus Fistulectomy in Trans-sphincteric Anal Ffistula.
A study testing LIFT and fistulectomy in people with Transsphincteric Anal Fistula, run by Zagazig University at 1 site in Egypt.
Trial summary
78 patients with transsphincteric fistula allocated into two groups group A underwent LIFT group B u nderwent fistulectomy , comparison between the outcome og both procedures Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Transsphincteric Anal Fistula
- What is being tested?
- LIFT and fistulectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2018to 28 Feb 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients with transsphincteric anal fistula
Who cannot join
- Anorectal malignancy.
- Patient with previous radiotherapy to the region.
- Those with fistula due to specific disease as Crohn's disease.
- Patients with anal incontinence.
- Patients with perianal collections.
- Patients on cytotoxic or immunosuppressive therapy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ligation of Intersphincteric Track (LIFT) Versus Fistulectomy in Trans-sphincteric Anal Fistula. Randomized Clinical Trial.
78 patients with transsphincteric fistula allocated into two groups group A underwent LIFT group B u nderwent fistulectomy , comparison between the outcome og both procedures
Read the detailed description
This randomized comparative clinical trial was carried out in Zagazig university hospitals, general surgery department, between March 2018 and February 2020, on 78 patients with transsphincteric anal fistula.
All patients were informed and signed a written consent for participation in this study, the study was approved by the local ethical committee of our university the sample size was calculated by the statistical unit of the local institutional review board participant selection; participant included in this study are those above 18 years old, suffering transsphincteric anal fistula diagnosed by clinical examination and magnetic resonant imaging (MRI) in doubtful cases, We excluded all patients with;
- Anorectal malignancy.
- Patient with previous radiotherapy to the region.
- Those with fistula due to specific disease as Crohn's disease.
- Patients with anal incontinence.
- Patients with perianal collections.
- Patients on cytotoxic or immunosuppressive therapy. Randomization; According to intervention,participants were randomly allocated using computer generated random numbers into two groups, group A (39 patients): Patients underwent intersphincteric ligation of fistulous track (LIFT) and group B (39 patients): Patients underwent fistulectomy.
Procedures ; All participants were subjected to full clinical examination including detailed history, formal digital rectal examination for assessment of anal sphincter integrity, identification of internal and external openings of the fistula, MRI was performed in those with doubtful clinical examination. Preoperative investigations performed according to American society of anesthesia (ASA) guidelines, all patients received 1 gm third generation cephalosporin with induction of anesthesia and continued for 24 hours postoperative, fleet enema was performed 12 hours and 2 hours before operation.
Surgical technique;
Under spinal anesthesia, participants under went digital rectal examination for identification of the internal and external openings and the fistulous track course, after identification of the external opening it was propped by 14 g cannula through which 2ml hydrogen peroxide was injected and traced through anoscope inside anal canal to identify the internal opening, after that the fistulous track was propped by malleable metal probe, the definitive procedure was then performed according to patient allocation:
in group A; a curvilinear incision was taken in the groove between internal and external anal sphincters over the track course, it was deepened by sharp and blunt dissection between both sphincters till reaching the propped fistulous track, using monopolar diathermy when needed, the track was dissected all around at this point, we used Vicryl 3\0 suture to ligate the fistulous track at two points the medial one as near as possible to the internal sphincter the lateral one is close as possible to the external sphincter, the track was cut in between both ligatures, the lateral part of the track was curetted and the skin around the internal opening was trimmed.
In group B; after identification and probing of the track fistulectomy was carried out by carrying out elliptical incision including internal and external openings, the fistulous track was excised severing the related part of the anal sphincters.
Hemostasis was achieved as needed, wounds was dressed using non adherent dressing, patients received non-steroidal analgesia as per need, patients was discharged after tolerating oral intake.
Follow up; It was achieved via outpatient clinics by the attending surgeon,participants were instructed to attend the clinic every week till complete wound healing , 3 and 6 months after wound healing, later on patients were contacted by phone after 1 year of the procedure, data to be collected throughout follow up included postoperative pain measured by visual analogue scale (VAS) , state of wound healing, state of continence measured by Vaizey score patient's questionnaire, recurrence or persistence of the fistula measured by history and clinical examination.
Statistical analysis; Operative and hospital stay time together with follow up data were collected and statistically analyzed using paired t test and Z test in SPSS program package 22
- Conditions
- Transsphincteric Anal Fistula
- Being tested
- LIFT, fistulectomy
- Keywords
- anal fistula, LIFT, fistulectomy
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIFTProcedure or surgery
ligation of the intersphincteric fistula track
fistulectomyProcedure or surgery
excision of the fistulous track with its internal and external orifices
| Study group | Role | What they receive |
|---|---|---|
| group A , LIFT | Active comparator | 39 patients underwnt ligation of the intersphincteric track( LIFT) for treatment of transsphincteric fistula Receives: Procedure: LIFT |
| group B fistulectomy | Active comparator | 39 patients under went fistulectomy for treatment of transsphincteric fistula Receives: Procedure: fistulectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrence
recurrence of the fistula after complete healing of wound detected by clinical examination
Measured: 8 weeks
incontinence
inability to control flatus or stool detected by Vaizy patient questionnaire
Measured: 1 week
operative time
time from 1st incision to wound packing counted in minutes
Measured: 1 hour
hospital stay
from admission to discharge measured in days
Measured: 1 day
postoperative pain
degree of pain measured by patient questionnaire visual analogue scale(from 1 to 10) the high the score the more sever the pain is
Measured: 1 day
Secondary outcomes (1)
wound complications
bleeding and local wound infection detected by clinical examination
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2020
- Study start1 Mar 2018
- Primary completion28 Feb 2020
- Study completion28 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Transsphincteric 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
- group A (39 patients): Patients underwent intersphincteric ligation of fistulous track (LIFT) group B (39 patients): Patients underwent fistulectomy.
- Masking
- None (open label)
- Enrolment
- 78 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
- NCT04351074
- Sponsor's protocol ID
- LIFT VS fistulectomy
- Acronym
- professor
- Status last verified
- Apr 2020
- First submitted
- 15 Apr 2020
- Last updated
- 20 Apr 2020
- 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 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ligation of Intersphincteric Track (LIFT) Versus Fistulectomy in Trans-sphincteric Anal Fistula. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT04351074
- Acronym / sponsor ID
- professor / LIFT VS fistulectomy
- Conditions
- Transsphincteric Anal Fistula
- Keywords
- anal fistula, LIFT, fistulectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 28 Feb 2020 (actual)
- First posted
- 17 Apr 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.
78 patients with transsphincteric fistula allocated into two groups group A underwent LIFT group B u nderwent fistulectomy , comparison between the outcome og both procedures
Detailed description
This randomized comparative clinical trial was carried out in Zagazig university hospitals, general surgery department, between March 2018 and February 2020, on 78 patients with transsphincteric anal fistula.
All patients were informed and signed a written consent for participation in this study, the study was approved by the local ethical committee of our university the sample size was calculated by the statistical unit of the local institutional review board participant selection; participant included in this study are those above 18 years old, suffering transsphincteric anal fistula diagnosed by clinical examination and magnetic resonant imaging (MRI) in doubtful cases, We excluded all patients with;
- Anorectal malignancy.
- Patient with previous radiotherapy to the region.
- Those with fistula due to specific disease as Crohn's disease.
- Patients with anal incontinence.
- Patients with perianal collections.
- Patients on cytotoxic or immunosuppressive therapy. Randomization; According to intervention,participants were randomly allocated using computer generated random numbers into two groups, group A (39 patients): Patients underwent intersphincteric ligation of fistulous track (LIFT) and group B (39 patients): Patients underwent fistulectomy.
Procedures ; All participants were subjected to full clinical examination including detailed history, formal digital rectal examination for assessment of anal sphincter integrity, identification of internal and external openings of the fistula, MRI was performed in those with doubtful clinical examination. Preoperative investigations performed according to American society of anesthesia (ASA) guidelines, all patients received 1 gm third generation cephalosporin with induction of anesthesia and continued for 24 hours postoperative, fleet enema was performed 12 hours and 2 hours before operation.
Surgical technique;
Under spinal anesthesia, participants under went digital rectal examination for identification of the internal and external openings and the fistulous track course, after identification of the external opening it was propped by 14 g cannula through which 2ml hydrogen peroxide was injected and traced through anoscope inside anal canal to identify the internal opening, after that the fistulous track was propped by malleable metal probe, the definitive procedure was then performed according to patient allocation:
in group A; a curvilinear incision was taken in the groove between internal and external anal sphincters over the track course, it was deepened by sharp and blunt dissection between both sphincters till reaching the propped fistulous track, using monopolar diathermy when needed, the track was dissected all around at this point, we used Vicryl 3\0 suture to ligate the fistulous track at two points the medial one as near as possible to the internal sphincter the lateral one is close as possible to the external sphincter, the track was cut in between both ligatures, the lateral part of the track was curetted and the skin around the internal opening was trimmed.
In group B; after identification and probing of the track fistulectomy was carried out by carrying out elliptical incision including internal and external openings, the fistulous track was excised severing the related part of the anal sphincters.
Hemostasis was achieved as needed, wounds was dressed using non adherent dressing, patients received non-steroidal analgesia as per need, patients was discharged after tolerating oral intake.
Follow up; It was achieved via outpatient clinics by the attending surgeon,participants were instructed to attend the clinic every week till complete wound healing , 3 and 6 months after wound healing, later on patients were contacted by phone after 1 year of the procedure, data to be collected throughout follow up included postoperative pain measured by visual analogue scale (VAS) , state of wound healing, state of continence measured by Vaizey score patient's questionnaire, recurrence or persistence of the fistula measured by history and clinical examination.
Statistical analysis; Operative and hospital stay time together with follow up data were collected and statistically analyzed using paired t test and Z test in SPSS program package 22
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- group A (39 patients): Patients underwent intersphincteric ligation of fistulous track (LIFT) group B (39 patients): Patients underwent fistulectomy.
| Arm | Type | Receives |
|---|---|---|
| group A , LIFT | Active comparator | Procedure: LIFT39 patients underwnt ligation of the intersphincteric track( LIFT) for treatment of transsphincteric fistula |
| group B fistulectomy | Active comparator | Procedure: fistulectomy39 patients under went fistulectomy for treatment of transsphincteric fistula |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients with transsphincteric anal fistula
Key exclusion criteria (6 listed)
- Anorectal malignancy.
- Patient with previous radiotherapy to the region.
- Those with fistula due to specific disease as Crohn's disease.
- Patients with anal incontinence.
- Patients with perianal collections.
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 |
|---|---|---|
| LIFTligation of the intersphincteric fistula track | Procedure or surgery | group A , LIFT |
| fistulectomyexcision of the fistulous track with its internal and external orifices | Procedure or surgery | group B fistulectomy |
Primary outcome
recurrence
Time frame: 8 weeks
recurrence of the fistula after complete healing of wound detected by clinical examination
incontinence
Time frame: 1 week
inability to control flatus or stool detected by Vaizy patient questionnaire
operative time
Time frame: 1 hour
time from 1st incision to wound packing counted in minutes
hospital stay
Time frame: 1 day
from admission to discharge measured in days
postoperative pain
Time frame: 1 day
degree of pain measured by patient questionnaire visual analogue scale(from 1 to 10) the high the score the more sever the pain is
1 secondary outcome
wound complications
Time frame: 1 week
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 20 Apr 2020.
- 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.
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 LIFT and fistulectomy in people with Transsphincteric 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 6 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 20 Apr 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?
recurrence (time frame: 8 weeks). The study lists 5 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 20 Apr 2020.