Loris Trenti1,2, Sebastiano Biondo3,4, Fernando Noguerales5, Jesus Nomdedeu6, Alba Coret6, Roland Scherer7, Domenico Fraccalvieri1,2, Riccardo Frago1,2, Esther Kreisler1,2. 1. Colorectal Unit, Department of General and Digestive Surgery, Bellvitge University Hospital, University of Barcelona, C/Feixa Llarga S/N, L'Hospitalet de Llobregat, 08907, Barcelona, Spain. 2. Bellvitge Biomedical Investigation Institute, Barcelona, Spain. 3. Colorectal Unit, Department of General and Digestive Surgery, Bellvitge University Hospital, University of Barcelona, C/Feixa Llarga S/N, L'Hospitalet de Llobregat, 08907, Barcelona, Spain. sbn.biondo@gmail.com. 4. Bellvitge Biomedical Investigation Institute, Barcelona, Spain. sbn.biondo@gmail.com. 5. Department of General and Digestive Surgery, University Hospital Principe de Asturias, University of Alcalá, Alcalá de Henares, Madrid, Spain. 6. Department of Gastrointestinal Surgery, Consorcio Hospitalario Provincial de Castellón de la Plana, Castellón de la Plana, Castellón, Spain. 7. Center of Colorectal and Pelvic Floor Surgery, Waldfriede Hospital, Berlin, Germany.
Abstract
BACKGROUND: The implantation of Gatekeeper ™ (GK) represents a new option for the treatment of fecal incontinence (FI). The aim of this study was to analyze the postoperative morbidity associated with GK and to determine its clinical efficacy after at least 1 year of follow-up. METHODS: This was a multicenter, retrospective and longitudinal study of patients with FI who were treated with GK at our institutions between January 2010 and December 2015. Patients with FI without sphincter lesions or with sphincter injuries < 120° and with low anterior resection syndrome were included. Postoperative complications, long-term adverse effects and migration were recorded. FI severity was assessed using the Vaizey score. Patients were classified as responders or non-responders according to the improvement of the Vaizey score (≥ than 50 and < 50%, respectively) during the first 6 months after implantation. RESULTS: Forty-nine consecutive patients treated with GK between 2010 and 2015 were included (11 males and 38 females, mean age 63.3 years, SD 13.5). No postoperative and long-term complications were observed. Prosthesis migration was observed in 51% of patients. Twenty-three patients (48%) were classified as responders and 25 (52%) as non-responders. The mean Vaizey score at baseline, 6, 12 months and last visit post-surgery in the responder group was, respectively, 13.3 (SD 3.8), 4.3 (SD 2.1), 4.2 (SD 3.6) and 5.7 (SD 5.3). Significant differences were observed between the mean baseline Vaizey score and the mean 6, 12 and last follow-up Vaizey score values (p < 0.001). In long-term follow-up (2.7 years (SD 1.1)), responders maintained an improvement of more than 50% of the baseline Vaizey score. In the non-responder group the mean number of migrated prostheses was higher than in the responder group (2.4 SD 2.5 vs. 1.0 SD 1.6; p = 0.040). CONCLUSIONS: GK is a safe and effective procedure in more than 50% of the patients for at least 1 year after the implantation.
BACKGROUND: The implantation of Gatekeeper ™ (GK) represents a new option for the treatment of fecal incontinence (FI). The aim of this study was to analyze the postoperative morbidity associated with GK and to determine its clinical efficacy after at least 1 year of follow-up. METHODS: This was a multicenter, retrospective and longitudinal study of patients with FI who were treated with GK at our institutions between January 2010 and December 2015. Patients with FI without sphincter lesions or with sphincter injuries < 120° and with low anterior resection syndrome were included. Postoperative complications, long-term adverse effects and migration were recorded. FI severity was assessed using the Vaizey score. Patients were classified as responders or non-responders according to the improvement of the Vaizey score (≥ than 50 and < 50%, respectively) during the first 6 months after implantation. RESULTS: Forty-nine consecutive patients treated with GK between 2010 and 2015 were included (11 males and 38 females, mean age 63.3 years, SD 13.5). No postoperative and long-term complications were observed. Prosthesis migration was observed in 51% of patients. Twenty-three patients (48%) were classified as responders and 25 (52%) as non-responders. The mean Vaizey score at baseline, 6, 12 months and last visit post-surgery in the responder group was, respectively, 13.3 (SD 3.8), 4.3 (SD 2.1), 4.2 (SD 3.6) and 5.7 (SD 5.3). Significant differences were observed between the mean baseline Vaizey score and the mean 6, 12 and last follow-up Vaizey score values (p < 0.001). In long-term follow-up (2.7 years (SD 1.1)), responders maintained an improvement of more than 50% of the baseline Vaizey score. In the non-responder group the mean number of migrated prostheses was higher than in the responder group (2.4 SD 2.5 vs. 1.0 SD 1.6; p = 0.040). CONCLUSIONS:GK is a safe and effective procedure in more than 50% of the patients for at least 1 year after the implantation.
Authors: Jennifer M Wu; Camille P Vaughan; Patricia S Goode; David T Redden; Kathryn L Burgio; Holly E Richter; Alayne D Markland Journal: Obstet Gynecol Date: 2014-01 Impact factor: 7.661
Authors: F Litta; A Parello; V De Simone; P Campennì; R Orefice; A A Marra; M Goglia; R Moroni; C Ratto Journal: Br J Surg Date: 2020-02-17 Impact factor: 6.939