PMID- 36268758
OWN - NLM
STAT- MEDLINE
DCOM- 20230327
LR  - 20230328
IS  - 1463-1318 (Electronic)
IS  - 1462-8910 (Linking)
VI  - 25
IP  - 3
DP  - 2023 Mar
TI  - Sclerotherapy with 3% polidocanol foam to treat second-degree haemorrhoidal 
      disease: Three-year follow-up of a multicentre, single arm, IDEAL phase 2b trial.
PG  - 386-395
LID - 10.1111/codi.16380 [doi]
AB  - BACKGROUND: Sclerotherapy with 3% polidocanol foam is becoming increasingly 
      popular for the treatment of symptomatic I-II or III degree haemorrhoidal disease 
      (HD). However, there are no studies that have reported a follow-up of more than 
      1 year. The purpose of this study was to analyse the long-term outcomes of 
      sclerotherapy with 3% polidocanol foam in the treatment of II-degree HD. METHODS: 
      This was an open label, single-arm, phase 2b trial conducted in 10 tertiary 
      referral centres for HD. A total of 183 patients with II-degree HD, aged between 
      18 and 75 years with symptomatic HD according to the Goligher classification and 
      unresponsive to medical treatment, were included in the study and underwent 
      sclerotherapy with 3% polidocanol foam. The efficacy was evaluated in terms of 
      bleeding score, haemorrhoidal disease symptom score (HDSS) and short health scale 
      for HD (SHS-HD) score. Successful treatment was defined as the complete absence 
      of bleeding episodes after 7 days (T1) according to the bleeding score. RESULTS: 
      The overall success rate ranged from 95.6% (175/183) at 1 year to 90.2% (165/183) 
      after the final 3 year follow-up. The recurrence rate, based on the primary 
      outcome, ranged from 12% (15/125) to 28% (35/125). The greatest increase in 
      recurrence (15) was recorded between 12 and 18 months of follow-up, then another 
      five between 18 and 24 months. Both the HDSS and the SHS score remained 
      statistically significant (p < 0.001) from a median preoperative value of 11 
      (10-13) and 18 (15-20) to 0 (0-2) and 4 (0-4), respectively. Symptom-free 
      (HDSS = 0) patients, excluding patients converted to surgery, increased from 
      55.5% (101/182) at 1 year to 65.1% at 3 years (110/169). There were no 
      intraoperative complications in redo-sclerotherapy nor additional adverse events 
      (AEs) compared to the first 12 months. CONCLUSIONS: Sclerotherapy with 3% 
      polidocanol foam is gradually establishing itself in the treatment of bleeding HD 
      due to its repeatability, safety, convenience in terms of direct and indirect 
      costs with the absence of discomfort for the patient as well as AEs rather than 
      an excellent overall success rate.
CI  - (c) 2022 The Authors. Colorectal Disease published by John Wiley & Sons Ltd on 
      behalf of Association of Coloproctology of Great Britain and Ireland.
FAU - Gallo, Gaetano
AU  - Gallo G
AUID- ORCID: 0000-0003-1066-4671
AD  - Department of Medical and Surgical Science, University of Catanzaro, Catanzaro, 
      Italy.
AD  - Minerva Surgical Service, Catanzaro, Italy.
AD  - Department of Surgical Sciences, Sapienza University of Rome, Rome, Italy.
FAU - Picciariello, Arcangelo
AU  - Picciariello A
AUID- ORCID: 0000-0002-6361-1111
AD  - Department of Emergency and Organ transplantation and Inter-Department Research 
      Centre for Pelvic Floor Disease (CIRPAP), University Aldo Moro of Bari, Bari, 
      Italy.
FAU - Pietroletti, Renato
AU  - Pietroletti R
AUID- ORCID: 0000-0002-0790-1050
AD  - Proctology Unit, Department of Biotechnological and Applied Clinical Sciences, 
      University of L'Aquila, L'Aquila, Italy.
FAU - Novelli, Eugenio
AU  - Novelli E
AD  - Biostat Research S.A.S, Borgomanero, Italy.
FAU - Sturiale, Alessandro
AU  - Sturiale A
AUID- ORCID: 0000-0002-0845-0933
AD  - Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, 
      Italy.
FAU - Tutino, Roberta
AU  - Tutino R
AUID- ORCID: 0000-0002-0891-4689
AD  - Chirurgia 1, Azienda ULSS 2 Marca Trevigiana, Ospedale Regionale Treviso, 
      Treviso, Italy.
FAU - Laforgia, Rita
AU  - Laforgia R
AD  - Surgical Unit "M. Rubino" Department of Emergency and Organ Transplantation, 
      University Aldo Moro of Bari, Bari, Italy.
FAU - Moggia, Elisabetta
AU  - Moggia E
AD  - Department of General Surgery, Infermi Hospital, Rivoli, Torino, Italy.
FAU - Pozzo, Mauro
AU  - Pozzo M
AD  - Department of General Surgery, "Degli Infermi" Hospital, Biella, Italy.
FAU - Roveroni, Maurizio
AU  - Roveroni M
AD  - Department of Surgery, Aosta Hospital, Aosta, Italy.
FAU - Bianco, Vincenzo
AU  - Bianco V
AD  - General Surgery Unit, Cetraro Hospital, Cetraro, Italy.
FAU - Realis Luc, Alberto
AU  - Realis Luc A
AD  - Department of Colorectal Surgery, S. Rita Clinic, Vercelli, Italy.
FAU - Giuliani, Antonio
AU  - Giuliani A
AD  - General Surgery Unit, San Salvatore Hospital, Department of Biotechnological and 
      Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy.
FAU - Diaco, Elia
AU  - Diaco E
AD  - Minerva Surgical Service, Catanzaro, Italy.
FAU - Naldini, Gabriele
AU  - Naldini G
AUID- ORCID: 0000-0002-9252-1377
AD  - Proctology and Pelvic Floor Clinical Centre, Cisanello University Hospital, Pisa, 
      Italy.
FAU - Trompetto, Mario
AU  - Trompetto M
AUID- ORCID: 0000-0002-1190-4692
AD  - Department of Colorectal Surgery, S. Rita Clinic, Vercelli, Italy.
FAU - Perinotti, Roberto
AU  - Perinotti R
AD  - Department of General Surgery, "Degli Infermi" Hospital, Biella, Italy.
FAU - D'Andrea, Vito
AU  - D'Andrea V
AUID- ORCID: 0000-0001-5709-2530
AD  - Department of Surgical Sciences, Sapienza University of Rome, Rome, Italy.
FAU - Lobascio, Pierluigi
AU  - Lobascio P
AUID- ORCID: 0000-0002-3368-4715
AD  - Surgical Unit "M. Rubino" Department of Emergency and Organ Transplantation, 
      University Aldo Moro of Bari, Bari, Italy.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20221109
PL  - England
TA  - Colorectal Dis
JT  - Colorectal disease : the official journal of the Association of Coloproctology of 
      Great Britain and Ireland
JID - 100883611
RN  - 0AWH8BFG9A (Polidocanol)
RN  - 0 (Sclerosing Solutions)
RN  - 3055-99-0 (dodecylnonaoxyethylene glycol monoether)
RN  - 3WJQ0SDW1A (Polyethylene Glycols)
SB  - IM
MH  - Humans
MH  - Adolescent
MH  - Young Adult
MH  - Adult
MH  - Middle Aged
MH  - Aged
MH  - Polidocanol/therapeutic use
MH  - *Sclerotherapy
MH  - *Hemorrhoids/drug therapy
MH  - Sclerosing Solutions/therapeutic use
MH  - Follow-Up Studies
MH  - Treatment Outcome
MH  - Polyethylene Glycols/therapeutic use/adverse effects
OTO - NOTNLM
OT  - bleeding haemorrhoids
OT  - follow-up
OT  - haemorrhoidal disease
OT  - polidocanol foam
OT  - sclerofoam trial
OT  - sclerotherapy
EDAT- 2022/10/22 06:00
MHDA- 2023/03/28 06:00
CRDT- 2022/10/21 05:22
PHST- 2022/09/12 00:00 [revised]
PHST- 2022/08/12 00:00 [received]
PHST- 2022/10/08 00:00 [accepted]
PHST- 2022/10/22 06:00 [pubmed]
PHST- 2023/03/28 06:00 [medline]
PHST- 2022/10/21 05:22 [entrez]
AID - 10.1111/codi.16380 [doi]
PST - ppublish
SO  - Colorectal Dis. 2023 Mar;25(3):386-395. doi: 10.1111/codi.16380. Epub 2022 Nov 9.