Ligation of Intersphincteric Fistula Tract Versus Rectal Advancement Flap in the Treatment of Complex Anal Fistula (LIFTRAF-RCT)
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ClinicalTrials.gov Identifier: NCT05263661 |
Recruitment Status : Unknown
Verified February 2022 by Jorge Alejandro Benavides Buleje, Hospital General Universitario Reina Sofía de Murcia.
Recruitment status was: Active, not recruiting
First Posted : March 2, 2022
Last Update Posted : March 2, 2022
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Objective: Rectal advancement flap (RAF) is currently considered the gold standard in the treatment of complex anal fistula (CAF). Clinical trials are a priority given the few consistent results available with level 1 evidence. We compare the results of two conservative sphincter techniques: ligation of intersphincteric fistula tract (LIFT) versus RAF.
Material and Method: A controlled, randomised clinical trial is conducted in patients operated between 2013 and 2016 in Hospital General Universitario Reina Sofia, Murcia, Spain. The primary objective was to evaluate relapse at 12 months of follow-up, and the secondary objectives were post-op anal continence (Wexner), post-operative complications (haematoma, infection of surgical site, suture dehiscence), duration of surgery and hospitalisation. Post-operative controls 1, 3, 6 and 12 months after surgery.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Anal Fistula | Procedure: LIFT Procedure: FLAP | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 72 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | A controlled, randomised clinical trial |
Masking: | Single (Outcomes Assessor) |
Masking Description: | Open |
Primary Purpose: | Treatment |
Official Title: | Ligation of Intersphincteric Fistula Tract Versus Rectal Advancement Flap in the Treatment of Complex Anal Fistula: Randomised Clinical Trial |
Actual Study Start Date : | January 1, 2013 |
Actual Primary Completion Date : | January 1, 2014 |
Estimated Study Completion Date : | January 1, 2023 |
Arm | Intervention/treatment |
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Experimental: LIFT
ligation of interesphincteric fistula tract
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Procedure: LIFT
Ligation of fistula tract between external and internal sphincter
Other Name: ligation of interesphincteric fistula tract |
Active Comparator: FLAP
Rectal advancement flap
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Procedure: FLAP
Creation of a partial wall rectal flap to close internal opening of fistula tract
Other Name: Rectal advancement flap |
- Curation [ Time Frame: 1 year ]Proportion of subjects in each treatment group without fistula recurrence after surgery
- Functionality [ Time Frame: 1 year ]Anal continence measured by Wexner Scale (0-20, higher is worst)
- Security [ Time Frame: 1 month ]Rate of Complications after surgery
- Time of recurrence [ Time Frame: 10 years ]time to fistula relapse afeter surgery
- Time of surgery [ Time Frame: 1 day ]Duration of surgery in each arm
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patient diagnosed with transsphincteric (medium or high) or suprasphincteric cryptoglandular anal fistula
- with no abscess at the time of surgery
- who agreed to participate and signed the informed consent form
- capable transsphincteric understanding and following study instructions
Exclusion Criteria:
- diagnosed with, or with a suspected diagnosis of, Crohn's disease
- diagnosed with, or with a suspected diagnosis of, malignant anal tumour
- diagnosed with, or with a suspected diagnosis of,tuberculosis or suppurative hidradenitis
- a history of radiotherapy of the ano-perineal region
- language difficulties that prevent comprehension of the study
- refusal to participate
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05263661
Principal Investigator: | Jorge Alejandro Benavides Buleje, PhD | Hospital General Universitario Reina Sofía |
Other Publications:
Responsible Party: | Jorge Alejandro Benavides Buleje, Principal Investigator, Hospital General Universitario Reina Sofía de Murcia |
ClinicalTrials.gov Identifier: | NCT05263661 |
Other Study ID Numbers: |
LIFTRAF-RCT JBB1 ( Other Identifier: HGU Reina Sofia's CEIC ) |
First Posted: | March 2, 2022 Key Record Dates |
Last Update Posted: | March 2, 2022 |
Last Verified: | February 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | If asked |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
anal fistula, lift, advancement flap, recurrence |
Rectal Fistula Fistula Pathological Conditions, Anatomical Intestinal Fistula Digestive System Fistula |
Digestive System Diseases Intestinal Diseases Gastrointestinal Diseases Rectal Diseases |