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Trial registered on ANZCTR


Registration number
ACTRN12612000819820
Ethics application status
Approved
Date submitted
1/08/2012
Date registered
6/08/2012
Date last updated
4/02/2020
Date data sharing statement initially provided
9/12/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
The Anal Fistula ligation of the intersphincteric tract (LIFT) with or without local injection of platelet rich plasma versus mucosal advancement flap for treatment of transsphincteric anal fistula
Scientific title
Comparison of healing, recurrence and quality of life between Anal Fistula ligation of the intersphincteric tract (LIFT)with or without local injection of platelet rich plasma and mucosal advancement flap for treatment of transsphincteric anal fistula in adults
Secondary ID [1] 280943 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Transsphincteric high anal fistula 287038 0
Condition category
Condition code
Surgery 287367 287367 0 0
Surgical techniques
Oral and Gastrointestinal 287403 287403 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All procedures will be performed under general or locoregional anaesthesia. Approximate duration is about 60-90 minutes. Prophylactic broad-spectrum antibiotics will be administered before surgery. During surgery the internal fistula tract opening will be identified. For LIFT: a probe is inserted into the external opening exiting through the internal opening. The intersphincteric groove is then identified, and a small circumanal incision (2 cm) overlying the fistula tract is made to enter the space between the internal and external sphincters. Diathermy and blunt dissection is used to dissect the intersphincteric plane and reach the probed fistula tract. The dissection is kept as close as possible to the internal anal sphincter (IAS), and two small retractors were used to open the space, gently separating the sphincters. The fistula tract is then encircled using a right-angle clamp, and two absorbable sutures (3-0 vicryl) were used to doubly secure and close the fistula tract as close as possible to the lateral margin of IAS and the medial margin of the external anal sphincter (EAS). At this point, the tract between these two sutures is divided, excised for few millimetres and sent for pathologic examination. In order to confirm the closure of both the internal and external fistula tract, H2O2 was injected from the internal and the external orifices. The intersphincteric plane is then irrigated with H2O2 and saline, checked for haemostasis and closed in two layers (muscle approximation and skin) using interrupted 3-0 vicryl. The external and internal orifices are left open to allow drainage. Antibiotic prophylaxis consists of second-generation cephalosporin and metronidazole for 5 days after surgery.
Intervention code [1] 285379 0
Treatment: Surgery
Comparator / control treatment
In case of LIFT with PRP , the PRP solution was
injected into the internal opening at the submucosal level with the injections along the wall of the fistula tract. The tract was then sealed with instillation of between 2 and 4 mL of the gelatinous platelet-poor fraction via the external opening and along the length of the fistula tract. then LIFT is done same as previously described
The rectal advancement flap was done according to the following technique. Approximate duration is about 60-90 minutes. Prophylactic broad-spectrum antibiotics will be administered before surgery.The internal opening was excised followed by mobilization of the mucosa, submucosa, and a small amount of muscular fibers from the internal sphincter complex. A rectal flap with a 2 to 3 cm broad base was mobilized. The rectal flap was mobilized sufficiently to cover the internal opening with overlap. Hemostasis was performed to prevent a hematoma under the flap. The fistula tract was curetted. The internal opening was not closed before advancing the flap over the internal opening. Finally the flap was sutured in the distal anal canal.
Control group
Active

Outcomes
Primary outcome [1] 287638 0
fistula closure rate. The fistula will be rated closed if the external and the internal opening are closed and no discharge is experienced
Timepoint [1] 287638 0
6 months
Primary outcome [2] 287639 0
recurrence. It is diagnosed if there is open track after it was closed at any point of follow-up
Timepoint [2] 287639 0
6 months
Primary outcome [3] 287640 0
Continence. Tested by wexner score
Timepoint [3] 287640 0
6 months
Secondary outcome [1] 298568 0
morbidity. By recording any complication related to heart, lung, wound...etc
Timepoint [1] 298568 0
3 months
Secondary outcome [2] 298569 0
postoperative pain.Postoperatively patients will be asked to grade their pain on a visual analogue scale (VAS: 0, no pain; 10, worst imaginable pain) on different moments during the follow-up.
Timepoint [2] 298569 0
1, 2 and 3 months
Secondary outcome [3] 298570 0
quality of life. Quality of life will be evaluated using the SF-36 questionnaire. The SF-36 measures eight health attributes: physical functioning, social functioning, role limitations due to physical problems, role limitations due to emotional problems, mental health, pain, vitality and general health perception.
Timepoint [3] 298570 0
6 months

Eligibility
Key inclusion criteria
Inclusion criteria are; age above 18 years, high anorectal fistula of cryptoglandular origin (transsphincteric, upper 2/3 of the sphinctercomplex which is confined by the puborectal sling and the end of the anal canal), and informed consent.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria are; no internal opening found during surgery, HIV-positive patients, Crohn's disease, malignant cause, tuberculosis, hydradenitis suppurativa, and pilonidal sinus disease.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
10/08/2012
Actual
2/01/2013
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
116
Accrual to date
90
Final
Recruitment outside Australia
Country [1] 4453 0
Egypt
State/province [1] 4453 0

Funding & Sponsors
Funding source category [1] 285732 0
Self funded/Unfunded
Name [1] 285732 0
Country [1] 285732 0
Egypt
Primary sponsor type
Individual
Name
khaled madbouly
Address
1 Shamblion street. Azarita, Faculty of Medicine, University of Alexandria, Alexandria, 21321
Country
Egypt
Secondary sponsor category [1] 284580 0
None
Name [1] 284580 0
Address [1] 284580 0
Country [1] 284580 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287738 0
Ethics committee, faculty of medicine, University of Alexandria
Ethics committee address [1] 287738 0
Ethics committee country [1] 287738 0
Egypt
Date submitted for ethics approval [1] 287738 0
Approval date [1] 287738 0
01/08/2012
Ethics approval number [1] 287738 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34512 0
Prof Khaled Madbouly
Address 34512 0
shamplion street- azarita- Alexandria- Egypt- 21321
Faculty of Medicine= University of alexandria
Country 34512 0
Egypt
Phone 34512 0
+2034802375
Fax 34512 0
Email 34512 0
khaled.madbouly@alexmed.edu.eg
Contact person for public queries
Name 17759 0
Khaled Madbouly
Address 17759 0
Faculty of medicine, Surgery department, University of Alexandria. Shamblion street. Azarita. Alexandria, 21321
Country 17759 0
Egypt
Phone 17759 0
+20 34802375
Fax 17759 0
Email 17759 0
khaled.madbouly@alexmed.edu.eg
Contact person for scientific queries
Name 8687 0
Khaled Madbouly
Address 8687 0
Faculty of medicine, Surgery department, University of Alexandria. Shamblion street. Azarita. Alexandria, 21321
Country 8687 0
Egypt
Phone 8687 0
+20 34802375
Fax 8687 0
Email 8687 0
khaled.madbouly@alexmed.edu.eg

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.