PMID- 28493393
OWN - NLM
STAT- MEDLINE
DCOM- 20191125
LR  - 20191125
IS  - 1463-1318 (Electronic)
IS  - 1462-8910 (Linking)
VI  - 20
IP  - 3
DP  - 2018 Mar
TI  - Final results of a European, multicentre, prospective, observational study of 
      Permacol collagen paste injection for the treatment of anal fistula.
PG  - 243-251
LID - 10.1111/codi.13715 [doi]
AB  - AIM: Permacol collagen paste (Permacol paste) is an acellular cross-linked 
      porcine dermal collagen matrix suspension for use in soft-tissue repair. The use 
      of Permacol paste in the filling of anorectal fistula tract is a new 
      sphincter-preserving method for fistula repair. The MASERATI100 study was a 
      prospective, observational clinical study with the objective to assess the 
      efficacy of Permacol collagen paste for anal fistula repair in 100 patients. 
      METHOD: Patients (n = 100) with anal fistula were treated, at 10 European 
      surgical sites, with a sphincter-preserving technique using Permacol paste. 
      Fistula healing was assessed at 1, 3, 6 and 12 months post-treatment, with the 
      primary end-point being healing at 6 months. Faecal continence and patient 
      satisfaction were surveyed at each follow-up; adverse events (AEs) were monitored 
      throughout the follow-up. RESULTS: At 6 months postsurgery, 56.7% of patients 
      were healed and the percentage healed was largely maintained, with 53.5% healed 
      at 12 months. Regarding AEs, 29.0% of patients had at least one AE, and 16.0% of 
      patients had one or more procedure-related AE. Most AEs reported were minor and 
      similar to those commonly observed after fistula treatment, and the incidence of 
      serious adverse events was low (4.0% of patients). Regardless of treatment 
      outcome, 73.0% of patients were satisfied or very satisfied with the procedure. 
      CONCLUSION: Permacol paste is a promising sphincter-preserving treatment for 
      anal fistulae and has minimal adverse side-effects.
CI  - Colorectal Disease (c) 2017 The Association of Coloproctology of Great Britain and 
      Ireland.
FAU - Giordano, P
AU  - Giordano P
AD  - Colorectal Department, Whipps Cross University Hospital, Barts Health, London, 
      UK.
FAU - Sileri, P
AU  - Sileri P
AD  - Surgery, University of Rome Tor Vergata, Rome, Italy.
FAU - Buntzen, S
AU  - Buntzen S
AD  - Colorectal Surgery, Department of Surgery, Aarhus University Hospital, Aarhus, 
      Denmark.
FAU - Nunoo-Mensah, J
AU  - Nunoo-Mensah J
AD  - Department of Colorectal Surgery, King's College Hospital, London, UK.
FAU - Lenisa, L
AU  - Lenisa L
AD  - General Surgery Unit, Casa di Cura Humanitas San Pio X, Milan, Italy.
FAU - Singh, B
AU  - Singh B
AD  - Leicester General Hospital, Leicester, UK.
FAU - Thorlacius-Ussing, O
AU  - Thorlacius-Ussing O
AD  - Department of Gastrointestinal Surgery, Aalborg University Hospital, Aalborg, 
      Denmark.
FAU - Griffiths, B
AU  - Griffiths B
AD  - NUTH Foundation Trust, Newcastle, UK.
FAU - Vujovic, Z
AU  - Vujovic Z
AD  - Ninewells Hospital & Medical School, Dundee, Scotland, UK.
FAU - Stuto, A
AU  - Stuto A
AD  - Coloproctology and Pelvic Floor Surgery, Policlinico Abano Terme, Padova, Italy.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Observational Study
PL  - England
TA  - Colorectal Dis
JT  - Colorectal disease : the official journal of the Association of Coloproctology of 
      Great Britain and Ireland
JID - 100883611
RN  - 0 (Ointments)
RN  - 0 (Permacol)
RN  - 9007-34-5 (Collagen)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Collagen/*administration & dosage
MH  - Drainage/*methods
MH  - Europe
MH  - Female
MH  - Humans
MH  - Injections
MH  - Male
MH  - Middle Aged
MH  - Ointments
MH  - Patient Satisfaction
MH  - Prospective Studies
MH  - Rectal Fistula/*therapy
MH  - Treatment Outcome
OTO - NOTNLM
OT  - Anal fistula
OT  - Permacol collagen paste
OT  - faecal continence
OT  - sphincter-preserving technique
EDAT- 2017/05/12 06:00
MHDA- 2019/11/26 06:00
CRDT- 2017/05/12 06:00
PHST- 2016/07/14 00:00 [received]
PHST- 2016/12/07 00:00 [accepted]
PHST- 2017/05/12 06:00 [pubmed]
PHST- 2019/11/26 06:00 [medline]
PHST- 2017/05/12 06:00 [entrez]
AID - 10.1111/codi.13715 [doi]
PST - ppublish
SO  - Colorectal Dis. 2018 Mar;20(3):243-251. doi: 10.1111/codi.13715.