A Multicentre Randomised Controlled Trial Comparing Safety, Efficacy, and Cost-Effectiveness of the Surgisis® Anal Fistula Plug versus Surgeon's Preference for Transsphincteric Fistula-in-Ano: The FIAT Trial

2019 ◽  
Author(s):  
David Jayne ◽  
John Scholefield ◽  
Damian Tolan ◽  
Richard Gray ◽  
Asha Senapati ◽  
...  
2010 ◽  
Vol 8 (4) ◽  
pp. 0-0
Author(s):  
Edgaras Palubinskas ◽  
Narimantas Evaldas Samalavičius ◽  
Lina Gudelytė

Edgaras Palubinskas1, Narimantas Evaldas Samalavičius2, Lina Gudelytė1 1 Vilniaus universiteto Medicinos fakultetas, M. K. Čiurlionio g. 21, LT-03101 Vilnius2 Vilniaus universiteto Onkologijos instituto Chirurgijos klinika ir Vilniaus universiteto Medicinos fakulteto Vidaus ligų, šeimos medicinos ir onkologijos klinika,Santariškių g. 1, LT-08406 VilniusEl. paštas: [email protected] Tikslas: Tyrimo tikslas buvo įvertinti išangės fistulės kamščio (IFK) efektyvumą, gydant aukštas išangės fistules. Metodai: Į apžvalgą iš viso įtraukta 19 darbų iš 31, išspausdinto 2006–2010 m. Iš įtrauktųjų 8 yra retrospektyvinės studijos, 9 prospektyvinės, viena dvigubai akla randomizuota studija ir viena prospektyvinė nerandomizuota kontrolinė studija. Bendras į šias studijas įtrauktų ligonių, gydytų išangės fistulės kamščio metodu, skaičius yra 551. Rezultatai: Pooperacinio stebėjo laikas buvo nuo 3 iki 24 mėnesių. Gydymo išangės fistulės kamščiu sėkmingumas – nuo 15,6 % iki 88 %. Iš 551 IFK gydytų ligonių 300 (54,4 %) pasveiko. Kriptoglanduliarinės kilmės (K) fistulės buvo sėkmingai išgydytos 55,1 % atvejų, o įvairios kilmės (I) – 54,9 %. Neaptikome patikimo ryšio tarp sėkmingo gydymo rezultatų ir paciento lyties, amžiaus, fistulės ilgio ar kilmės. Išvados: Išangės fistulės kamščio metodas yra patikimas gydyti sudėtingas fistula-in-ano. Ateities tyrimai turėtų padėti aiškiau apibrėžti gydymo išangės fistulės kamščiu metodo vietą išangės fistulių chirurgijoje. Reikšminiai žodžiai: fistula-in-ano, išangės fistulės kamštis, ligos atkrytis, tiesiosios žarnos lopas. Anal fistula plug for the treatment of complex fistula-in-ano Edgaras Palubinskas1, Narimantas Evaldas Samalavičius2, Lina gudelytė1 1 Vilnius University Medical Faculty, M. K. Čiurlionio str. 21, LT-03101 Vilnius, Lithuania2 Vilnius University, Institute of Oncology, Clinic of Surgery,Santariškių str. 1, LT-08406 Vilnius, LithuaniaE-mail: [email protected] Purpose: The aim of the study was to evaluate the efficacy of the anal fistula plug (AFP) for the treatment of fistula-in-ano. Methods: A total of 31 studies, published since 2006 to 2010 were extracted and 19 of them were finally included in this systematic review. 8 were retrospective case series, 9 prospective studies, 1 prospective non-randomized controlled trial and 1 randomized controlled trial. In these 19 studies, a total of 551 patients were included, who were treated with anal fistula plug. Results: The follow-up period ranged from 3–24 months. The AFP procedure had a success rate ranging from 15.6–88 %. From 551 patients treated with AFP, 300 (54.4 %) were cured. The success rate in patients with cryptoglandular origin (K) was 55.1 % and the success rate in patients with fistulas of other origin was 54.9 %. We did not notice difference in success rate between age, gender, fistula anatomy and etiology. Conclusion: The anal fistula plug method is a reliable method in treat of complex fistula-in-ano. Future studies should help to clarify the place of anal fistula plug in anal fistula surgery. Key words: Fistula-in-ano, anal plug, recurrence, advancement flap.


Diabetes ◽  
2019 ◽  
Vol 68 (Supplement 1) ◽  
pp. 39-LB
Author(s):  
DEBORAH MARY BROADBENT ◽  
AMU WANG ◽  
CHRISTOPHER P. CHEYNE ◽  
JAMES G. LATHE ◽  
IRENE M. STRATTON ◽  
...  

2021 ◽  
pp. 1-14
Author(s):  
Christopher Newton ◽  
Gurpreet Singh ◽  
David Nolan ◽  
Vicky Booth ◽  
Claire Diver ◽  
...  

BACKGROUND: Combined physical and psychological programmes (CPPP) are recommended for people with disabling low back pain (LBP). Cognitive Functional Therapy (CFT) is a physiotherapist-led low intensity CPPP with positive effects in previous studies. The clinical and cost effectiveness of CFT has not previously been evaluated in a randomised controlled trial (RCT) in the United Kingdom (UK) National Health Service (NHS). Before a definitive RCT can be completed it is necessary to determine if completing such a study is possible. PURPOSE: To determine the feasibility of completing a definitive RCT, that will evaluate the clinical and cost-effectiveness of CFT in comparison to usual physiotherapy care for people with persistent LBP in the UK NHS. METHODS: A pragmatic two-arm parallel feasibility RCT comparing CFT with usual physiotherapy care for people with persistent LBP will be completed. Sixty participants will be randomly allocated to receive CFT or usual physiotherapy care. The primary outcome will be feasibility of completing a definitive RCT. Participant reported outcome measures will be recorded at baseline, three, six and twelve-month follow-up, including disability, pain intensity, quality of life and psychosocial function. Data will be analysed descriptively. A qualitative process evaluation will explore the acceptability of the research processes and interventions. DISCUSSION: The rationale and methodological design of a mixed methods feasibility RCT is presented. This study aims to inform the planning, design and completion of a future definitive RCT in the UK NHS. The results will be disseminated through peer reviewed open access journal publication.


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