Anal FistulaNCT03311035
LIFT Technique Versus Seton in Management of Anal Fistula
A study testing Seton and LIFT technique in people with Anal Fistula, run by Assiut University.
Trial summary
Abscesses and anal fistulas represent about 70% of perianal suppuration, with an estimated incidence of 1/10,000 inhabitants per year and representing 5% of queries in coloproctology. Read more about this study
- Who is it for?
- Ages 16 to 80 years
- Conditions the study is for
- Anal Fistula
- What is being tested?
- Seton and LIFT technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 18 Oct 2017to 30 Dec 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 16 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All patients who will undergo LIFT technique and Seton for management of anal fistula at General surgery department - Assiut University
Who cannot join
- patients under age of 16 years old.
- patients with malignant fistula.
- patients with crohn's disease.
- patients with Tuberculosis.
- patients with intersphincteric fistula. Patients with anal fistula and anal incontinence
Trial locations and contacts
No sites are listed yet.
Faculty of Medicine Faculty of Medicine-Assiut University contact
About this study
Abscesses and anal fistulas represent about 70% of perianal suppuration, with an estimated incidence of 1/10,000 inhabitants per year and representing 5% of queries in coloproctology.
Anal fistula is the chronic phase of anorectal infection is characterized by chronic purulent drainage or cyclic pain associated with acute relapse of the abscess followed by intermittent spontaneous decompression.
Read more
Perianal fistulas have a troublesome pathology. The most widely accepted theory is that anal abscess is caused by infection of an anal crypt gland. Suppuration moves from the anal gland to the inter-sphincteric space, forming an abscess leading to the development of a fistula. The incidence of fistula following an abscess is nearly 33%.
A fistula can cause pain, perianal swelling, discharge, bleeding, and other nonspecific symptoms.
The diagnosis of fistula-in-ano may include a digital rectal examination, endoanal ultrasound, fistulography, and MRI.
The management of the disease is difficult and sometimes a challenge for the surgeon.
The ideal treatment is based on three central principles: control of sepsis, closure of the fistula and maintenance of continence.
The management of complex fistulas needs to balance the outcomes of cure and continence. Success is usually determined by identification of the primary opening and dividing the least amount of muscle as possible.
There is a risk of sphincter muscle damage during fistulotomy, which can lead to an unacceptable risk of anal incontinence of varying degrees.
The surgical techniques described for the treatment of fistula-in-ano are fistulotomy, core-out fistulectomy, seton placement, endorectal advancement flap, injection of fibrin glue, insertion of a fistula plug, video-assisted anal fistula treatment (VAAFT) and ligation of the intersphincteric fistula tract (LIFT), Surgical techniques are composed of 2 broad categories, including sphincter sacrificing procedures, such as, fistulotomy, fistulectomy and cutting seton. and sphincter-preserving procedures, such as fibrin glue injection, fistula plug, rectal advancement flap, VAAFT and LIFT. In general, sphincter sacrificing procedures have high success rates but are associated with high rates of fecal incontinence. In contrast, sphincter-preserving procedures have more modest success rates but are associated with a relatively minimal risk of changes in continence.
While low transsphincteric fistulae are well-addressed by fistulotomy (i.e., lay-open technique) with minimal change in long-term bowel habits, fistulae which involve more than 30 % of the internal sphincter carry a substantial risk of fecal incontinence with this approach.
Endorectal advancement flap is technically difficult and associated with high recurrence rate up to 50% and risk of incontinence up to 35%.
Fibrin glue and anal fistula plug have a little effect on incontinence but are associated with high recurrence up to 60 % and are costive.
VAAFT is effective method but is highly costive.
Setons can be employed as cutting and non-cutting kinds as dividers or markers . A few types of setons used are the Ayurveda-medicated thread , braided sutures thread, rubber band , Penrose drains and cable tie seton . Seton material should be non-absorbable, from non-slippage material, comfortable and least irritant for the patient and equally ejective in causing focal reaction in the track, leading to fibrosis .
However, setons may cause patient discomfort, both from irritation and from persistent drainage. In addition the incontinence rate may reach 67%.
The ligation of intersphincteric fistula tract (LIFT) was first described by Rojanasakul and colleagues in 2007. Since then, this technique has become popular among providers due to its simple technical elements, particularly when compared to anorectal advancement flaps, and favorable success rate. Among the many studies published in the literature, the success rate after LIFT ranges from 40 to 95 %, with a recurrence rate of 6-28 % .3,5-28 In comparison, success after advancement flap ranges from 60 to 94 %.
Read the detailed description
This study is a prospective study;
- Methodology:
Patients will be classified into two groups according to the surgical procedure performed as follows:
- Group A: Patients undergoing cutting Seton.
- Group B: Patients undergoing LIFT technique.
Aim OF THE STUDY:
To compare between Seton and LIFT technique in management of anal fistula according to ;
1-Feasibility of the technique. 3-Postoperative pain and use of analgesia. 4-Healing time. 5-Recurrence rate. 6-Occurrence of fecal incontinence.
- Conditions
- Anal Fistula
- Being tested
- Seton, LIFT technique
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SetonProcedure or surgery
The identification of the primary tract of the fistula and the placement of the thread can be performed in one single step. a non-absorbable, braided thread is inserted . After excision of the external opening and the extrasphincteric parts of the fistula, the thread is grasped and is pulled out of the anus .The thread is cut in two parts. The mucosa is incised over the muscular bridge . One thread is tied snugly around the muscle; the other is tied loosely .The snugly tied seton has to be replaced after 14 days to provide appropriate tension to cut slowly trough the muscle. This can easily be achieved with the second loosely tied seton . A new thread is folded in the middle and connected to the opened sling of the loose seton using a special knot shown in.The old thread is removed and in the same maneuver two new setons are placed. Again, one thread is tied snugly around the remaining portion of the sphincter muscle; the other is tied loosely .
LIFT techniqueProcedure or surgery
The internal opening was identified . The intersphincteric plane was entered via a curvilinear incision corresponding to the site of the internal opening at the intersphincteric groove. The intersphincteric plane was developed by meticulous scissor and diathermy dissection up to the tract. Once identified, a small, right-angled clamp was hooked underneath or a tape passed round it. the tract was then transfixed close to the internal sphincter with 2/0 polyglactin suture . Saline was gently injected through the external opening to confirm that the tract was no longer patent and it was then divided distal to the point of ligation . After light traction, a segment of the distal tract was excised and, if needed, any defect in the external sphincter was closed. The intersphincteric incision wound was re-approximated loosely with interrupted 2/0 Vicryl. Partial core-out of the fistula tract was performed from the external opening to the external sphincter.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | patients undergoing ligation of intersphincteric fistula tract (LIFT technique) Receives: Procedure: LIFT technique |
| Group B | Experimental | patients undergoing Seton method Receives: Procedure: Seton |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of the fistula
re-appearance of pus discharge or pain after healing of the fistula
Measured: Up to one year from last case
Secondary outcomes (3)
Postoperative pain
intensity of postoperative pain according to the number of doses needed for analgesia
Measured: up to 2 weeks postoperatively for each case
Fecal Incontinence
patient complaining of involuntary passage of flatus or stool and confirmed by Digital Rectal examination and Electromyography
Measured: up to 2 months postoperatively for each case
Healing time of the wound
number of days needed for closure of skin at external opening
Measured: up to 3 months postoperatively for each case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2017
- Study start18 Oct 2017 (estimated)
- Primary completion1 Dec 2019 (estimated)
- Study completion30 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Anal FistulaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be classified into two groups according to the surgical procedure performed as follows: * Group A: Patients undergoing cutting Seton. * Group B: Patients undergoing LIFT technique
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abanob Hosny, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03311035
- Sponsor's protocol ID
- Anal fistula
- Status last verified
- Sep 2017
- First submitted
- 25 Aug 2017
- Last updated
- 19 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: All patients were discharged with analgesics and stool softeners and received oral ofloxacin and metronidazole for 1 week. Before being discharged, the patients were shown how to clean their wound and were advised to take topical antibiotic ointment. After hospital discharge, patients were seen 2 week after the initial procedure. The second consultation was 2 weeks after the first visit and the third visit will be after 6 month from the operation and the fourth visit will be after one year from the operation .At each visit the patient was interviewed for clinical continence status. The intersphincteric incision wound was examined, the sites of the previous internal and external openings were palpated and sphincter tone was assessed. After healing, the patient was asked to return should any recurrent pain, swelling or discharge occur. All patients with a documented healed fistula were also contacted by telephone at the time of the present study to enquire of possible recurrence.
Publications
Dudukgian H, Abcarian H. Why do we have so much trouble treating anal fistula? World J Gastroenterol. 2011 Jul 28;17(28):3292-6. doi: 10.3748/wjg.v17.i28.3292.
PubMed 21876616Xu Y, Tang W. Ligation of Intersphincteric Fistula Tract Is Suitable for Recurrent Anal Fistulas from Follow-Up of 16 Months. Biomed Res Int. 2017;2017:3152424. doi: 10.1155/2017/3152424. Epub 2017 Feb 8.
PubMed 28271064Chen HJ, Sun GD, Zhu P, Zhou ZL, Chen YG, Yang BL. Effective and long-term outcome following ligation of the intersphincteric fistula tract (LIFT) for transsphincteric fistula. Int J Colorectal Dis. 2017 Apr;32(4):583-585. doi: 10.1007/s00384-016-2723-2. Epub 2016 Nov 23.
PubMed 27878618Khadia M, Muduli IC, Das SK, Mallick SN, Bag L, Pati MR. Management of Fistula-In-Ano with Special Reference to Ligation of Intersphincteric Fistula Tract. Niger J Surg. 2016 Jan-Jun;22(1):1-4. doi: 10.4103/1117-6806.169818.
PubMed 27013849Mushaya C, Bartlett L, Schulze B, Ho YH. Ligation of intersphincteric fistula tract compared with advancement flap for complex anorectal fistulas requiring initial seton drainage. Am J Surg. 2012 Sep;204(3):283-9. doi: 10.1016/j.amjsurg.2011.10.025. Epub 2012 May 19.
PubMed 22609079Charua-Guindic L, Mendez-Moran MA, Avendano-Espinosa O, Jimenez-Bobadilla B, Charua-Levy E. [Complex anal fistula treated with cutting seton]. Cir Cir. 2007 Sep-Oct;75(5):351-6. Spanish.
PubMed 18158881Ye F, Tang C, Wang D, Zheng S. Early experience with the modificated approach of ligation of the intersphincteric fistula tract for high transsphincteric fistula. World J Surg. 2015 Apr;39(4):1059-65. doi: 10.1007/s00268-014-2888-1.
PubMed 25472892Zirak-Schmidt S, Perdawood SK. Management of anal fistula by ligation of the intersphincteric fistula tract - a systematic review. Dan Med J. 2014 Dec;61(12):A4977.
PubMed 25441733
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFT Technique Versus Seton in Management of Anal Fistula
- ClinicalTrials.gov ID
- NCT03311035
- Acronym / sponsor ID
- Anal fistula
- Conditions
- Anal Fistula
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 18 Oct 2017 (estimated)
- Primary completion
- 1 Dec 2019 (estimated)
- Study completion
- 30 Dec 2019 (estimated)
- First posted
- 16 Oct 2017 (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.
Abscesses and anal fistulas represent about 70% of perianal suppuration, with an estimated incidence of 1/10,000 inhabitants per year and representing 5% of queries in coloproctology.
Anal fistula is the chronic phase of anorectal infection is characterized by chronic purulent drainage or cyclic pain associated with acute relapse of the abscess followed by intermittent spontaneous decompression.
Perianal fistulas have a troublesome pathology. The most widely accepted theory is that anal abscess is caused by infection of an anal crypt gland. Suppuration moves from the anal gland to the inter-sphincteric space, forming an abscess leading to the development of a fistula. The incidence of fistula following an abscess is nearly 33%.
A fistula can cause pain, perianal swelling, discharge, bleeding, and other nonspecific symptoms.
The diagnosis of fistula-in-ano may include a digital rectal examination, endoanal ultrasound, fistulography, and MRI.
The management of the disease is difficult and sometimes a challenge for the surgeon.
The ideal treatment is based on three central principles: control of sepsis, closure of the fistula and maintenance of continence.
The management of complex fistulas needs to balance the outcomes of cure and continence. Success is usually determined by identification of the primary opening and dividing the least amount of muscle as possible.
There is a risk of sphincter muscle damage during fistulotomy, which can lead to an unacceptable risk of anal incontinence of varying degrees.
The surgical techniques described for the treatment of fistula-in-ano are fistulotomy, core-out fistulectomy, seton placement, endorectal advancement flap, injection of fibrin glue, insertion of a fistula plug, video-assisted anal fistula treatment (VAAFT) and ligation of the intersphincteric fistula tract (LIFT), Surgical techniques are composed of 2 broad categories, including sphincter sacrificing procedures, such as, fistulotomy, fistulectomy and cutting seton. and sphincter-preserving procedures, such as fibrin glue injection, fistula plug, rectal advancement flap, VAAFT and LIFT. In general, sphincter sacrificing procedures have high success rates but are associated with high rates of fecal incontinence. In contrast, sphincter-preserving procedures have more modest success rates but are associated with a relatively minimal risk of changes in continence.
While low transsphincteric fistulae are well-addressed by fistulotomy (i.e., lay-open technique) with minimal change in long-term bowel habits, fistulae which involve more than 30 % of the internal sphincter carry a substantial risk of fecal incontinence with this approach.
Endorectal advancement flap is technically difficult and associated with high recurrence rate up to 50% and risk of incontinence up to 35%.
Fibrin glue and anal fistula plug have a little effect on incontinence but are associated with high recurrence up to 60 % and are costive.
VAAFT is effective method but is highly costive.
Setons can be employed as cutting and non-cutting kinds as dividers or markers . A few types of setons used are the Ayurveda-medicated thread , braided sutures thread, rubber band , Penrose drains and cable tie seton . Seton material should be non-absorbable, from non-slippage material, comfortable and least irritant for the patient and equally ejective in causing focal reaction in the track, leading to fibrosis .
However, setons may cause patient discomfort, both from irritation and from persistent drainage. In addition the incontinence rate may reach 67%.
The ligation of intersphincteric fistula tract (LIFT) was first described by Rojanasakul and colleagues in 2007. Since then, this technique has become popular among providers due to its simple technical elements, particularly when compared to anorectal advancement flaps, and favorable success rate. Among the many studies published in the literature, the success rate after LIFT ranges from 40 to 95 %, with a recurrence rate of 6-28 % .3,5-28 In comparison, success after advancement flap ranges from 60 to 94 %.
Detailed description
This study is a prospective study;
- Methodology:
Patients will be classified into two groups according to the surgical procedure performed as follows:
- Group A: Patients undergoing cutting Seton.
- Group B: Patients undergoing LIFT technique.
Aim OF THE STUDY:
To compare between Seton and LIFT technique in management of anal fistula according to ;
1-Feasibility of the technique. 3-Postoperative pain and use of analgesia. 4-Healing time. 5-Recurrence rate. 6-Occurrence of fecal incontinence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Patients will be classified into two groups according to the surgical procedure performed as follows: * Group A: Patients undergoing cutting Seton. * Group B: Patients undergoing LIFT technique
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: LIFT techniquepatients undergoing ligation of intersphincteric fistula tract (LIFT technique) |
| Group B | Experimental | Procedure: Setonpatients undergoing Seton method |
Who may qualify
- Ages
- 16 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who will undergo LIFT technique and Seton for management of anal fistula at General surgery department - Assiut University
Key exclusion criteria (5 listed)
- patients under age of 16 years old.
- patients with malignant fistula.
- patients with crohn's disease.
- patients with Tuberculosis.
- patients with intersphincteric fistula. Patients with anal fistula and anal incontinence
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 |
|---|---|---|
| SetonThe identification of the primary tract of the fistula and the placement of the thread can be performed in one single step. a non-absorbable, braided thread is inserted . After excision of the external opening and the extrasphincteric parts of the fistula, the thread is grasped and is pulled out of the anus .The thread is cut in two parts. The mucosa is incised over the muscular bridge . One thread is tied snugly around the muscle; the other is tied loosely .The snugly tied seton has to be replaced after 14 days to provide appropriate tension to cut slowly trough the muscle. This can easily be achieved with the second loosely tied seton . A new thread is folded in the middle and connected to the opened sling of the loose seton using a special knot shown in.The old thread is removed and in the same maneuver two new setons are placed. Again, one thread is tied snugly around the remaining portion of the sphincter muscle; the other is tied loosely . | Procedure or surgery | Group B |
| LIFT techniqueThe internal opening was identified . The intersphincteric plane was entered via a curvilinear incision corresponding to the site of the internal opening at the intersphincteric groove. The intersphincteric plane was developed by meticulous scissor and diathermy dissection up to the tract. Once identified, a small, right-angled clamp was hooked underneath or a tape passed round it. the tract was then transfixed close to the internal sphincter with 2/0 polyglactin suture . Saline was gently injected through the external opening to confirm that the tract was no longer patent and it was then divided distal to the point of ligation . After light traction, a segment of the distal tract was excised and, if needed, any defect in the external sphincter was closed. The intersphincteric incision wound was re-approximated loosely with interrupted 2/0 Vicryl. Partial core-out of the fistula tract was performed from the external opening to the external sphincter. | Procedure or surgery | Group A |
Primary outcome
Recurrence of the fistula
Time frame: Up to one year from last case
re-appearance of pus discharge or pain after healing of the fistula
3 secondary outcomes
Postoperative pain
Time frame: up to 2 weeks postoperatively for each case
Fecal Incontinence
Time frame: up to 2 months postoperatively for each case
Healing time of the wound
Time frame: up to 3 months postoperatively for each case
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2017.
- Background: PubMed 21876616Dudukgian H, Abcarian H. Why do we have so much trouble treating anal fistula? World J Gastroenterol. 2011 Jul 28;17(28):3292-6. doi: 10.3748/wjg.v17.i28.3292.
- Background: PubMed 28271064Xu Y, Tang W. Ligation of Intersphincteric Fistula Tract Is Suitable for Recurrent Anal Fistulas from Follow-Up of 16 Months. Biomed Res Int. 2017;2017:3152424. doi: 10.1155/2017/3152424. Epub 2017 Feb 8.
- Background: PubMed 27878618Chen HJ, Sun GD, Zhu P, Zhou ZL, Chen YG, Yang BL. Effective and long-term outcome following ligation of the intersphincteric fistula tract (LIFT) for transsphincteric fistula. Int J Colorectal Dis. 2017 Apr;32(4):583-585. doi: 10.1007/s00384-016-2723-2. Epub 2016 Nov 23.
- Background: PubMed 27013849Khadia M, Muduli IC, Das SK, Mallick SN, Bag L, Pati MR. Management of Fistula-In-Ano with Special Reference to Ligation of Intersphincteric Fistula Tract. Niger J Surg. 2016 Jan-Jun;22(1):1-4. doi: 10.4103/1117-6806.169818.
- Background: PubMed 22609079Mushaya C, Bartlett L, Schulze B, Ho YH. Ligation of intersphincteric fistula tract compared with advancement flap for complex anorectal fistulas requiring initial seton drainage. Am J Surg. 2012 Sep;204(3):283-9. doi: 10.1016/j.amjsurg.2011.10.025. Epub 2012 May 19.
- Background: PubMed 18158881Charua-Guindic L, Mendez-Moran MA, Avendano-Espinosa O, Jimenez-Bobadilla B, Charua-Levy E. [Complex anal fistula treated with cutting seton]. Cir Cir. 2007 Sep-Oct;75(5):351-6. Spanish.
- Background: PubMed 25472892Ye F, Tang C, Wang D, Zheng S. Early experience with the modificated approach of ligation of the intersphincteric fistula tract for high transsphincteric fistula. World J Surg. 2015 Apr;39(4):1059-65. doi: 10.1007/s00268-014-2888-1.
- Background: PubMed 25441733Zirak-Schmidt S, Perdawood SK. Management of anal fistula by ligation of the intersphincteric fistula tract - a systematic review. Dan Med J. 2014 Dec;61(12):A4977.
- Individual participant dataSharing planned: Undecided. All patients were discharged with analgesics and stool softeners and received oral ofloxacin and metronidazole for 1 week. Before being discharged, the patients were shown how to clean their wound and were advised to take topical antibiotic ointment. After hospital discharge, patients were seen 2 week after the initial procedure. The second consultation was 2 weeks after the first visit and the third visit will be after 6 month from the operation and the fourth visit will be after one year from the operation .At each visit the patient was interviewed for clinical continence status. The intersphincteric incision wound was examined, the sites of the previous internal and external openings were palpated and sphincter tone was assessed. After healing, the patient was asked to return should any recurrent pain, swelling or discharge occur. All patients with a documented healed fistula were also contacted by telephone at the time of the present study to enquire of possible recurrence.
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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.
Faculty of Medicine Faculty of Medicine-Assiut University contact
Questions about this trial
What is this clinical trial studying?
A study testing Seton and LIFT technique in people with Anal Fistula, run by Assiut University.
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: status not confirmed, as of the sponsor's last update on 19 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
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 Abanoub hosny, MBBCh (0201019341572, abanob.hosni55555@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence of the fistula (time frame: Up to one year from last case). 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 NCT03311035, which also lists 8 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 19 Oct 2017.