Walter R Marti1, Gaudenz Curti1, Heinz Wehrli2, Felix Grieder3, Michael Graf4, Beat Gloor5, Markus Zuber6, Nicolas Demartines7, Fabrizio Fasolini8, Bruno Lerf9, Christoph Kettelhack10, Christiane Andrieu11, Martin Bigler11, Stefanie Hayoz11, Karin Ribi11, Christian Hamel12. 1. Department of Visceral Surgery, Kantonsspital Aarau, Aarau, Switzerland. 2. Department of Visceral Surgery, Hirslandenklinik, Zürich, Switzerland. 3. Department of Visceral Surgery, Kantonsspital Winterthur, Winterthur, Switzerland. 4. Department of Visceral Surgery, Kantonsspital Luzern, Luzern, Switzerland. 5. Universitätslinik für Viszerale Chirurgie, Inselspital, Bern, Switzerland. 6. Department of Surgery, Kantonsspital Olten, Switzerland. 7. Service de Chirurgie Viscérale, CHUV, Lausanne, Switzerland. 8. Department of Surgery, IOSI, Mendrisio, Switzerland. 9. Department of General and Visceral Surgery, Kantonspital Zug, Switzerland. 10. Clinic of General Surgery, Basel University Hospital, Basel, Switzerland. 11. Coordinating Center, Bern, Switzerland. 12. Clinic for General and Visceral Surgery, Regional Hospital Lörrach, Lörrach, Germany.
Abstract
OBJECTIVE: To compare, in a phase 3, prospective, randomized, multi-center clinical trial functional outcome of reconstruction procedures following total mesorectal excision (TME). SUMMARY BACKGROUND DATA: Intestinal continuity reconstruction following TME is accompanied by postoperative defecation dysfunctions known as "anterior resection syndrome." Commonly used reconstruction techniques are straight colorectal anastomosis (SCA), colon J -pouch (CJP), and side-to-end anastomosis (SEA). Comparison of their functional outcomes in prospective, randomized, multi-center studies, including long-term assessments, is lacking. METHODS:Patients requiring TME for histologically proven rectal tumor, with or without neoadjuvant treatment, age ≥ 18 years, normal sphincter function without history of incontinence, any pretreatment staging or adenoma, expected R0-resection, were randomized for standardized SCA, CJP, or SEA procedures. Primary endpoint was comparison of composite evacuation scores 12 months after TME. Comparison of composite evacuation and incontinence scores at 6, 18 and 24 months after surgery, morbidity, and overall survival represented secondary endpoints. Analysis was based on "per protocol" (PP) population, fully complying with trial requirements, and intention-to treat (ITT) population. RESULTS:Three hundred thirty-six patients from 15 hospitals were randomized. PP population included 257 patients (JCP = 63; SEA = 95; SCA = 99). Composite evacuation scores of PP and ITT populations did not show statistically significant differences among the 3 groups at any time point. Similarly, composite incontinence scores for PP and ITT populations showed no statistically significant difference among the 3 trial arms at any time point. CONCLUSIONS: Within boundaries of investigated procedures, surgeons in charge may continue to perform reconstruction of intestinal continuity following TME at their technical preference.
RCT Entities:
OBJECTIVE: To compare, in a phase 3, prospective, randomized, multi-center clinical trial functional outcome of reconstruction procedures following total mesorectal excision (TME). SUMMARY BACKGROUND DATA: Intestinal continuity reconstruction following TME is accompanied by postoperative defecation dysfunctions known as "anterior resection syndrome." Commonly used reconstruction techniques are straight colorectal anastomosis (SCA), colon J -pouch (CJP), and side-to-end anastomosis (SEA). Comparison of their functional outcomes in prospective, randomized, multi-center studies, including long-term assessments, is lacking. METHODS:Patients requiring TME for histologically proven rectal tumor, with or without neoadjuvant treatment, age ≥ 18 years, normal sphincter function without history of incontinence, any pretreatment staging or adenoma, expected R0-resection, were randomized for standardized SCA, CJP, or SEA procedures. Primary endpoint was comparison of composite evacuation scores 12 months after TME. Comparison of composite evacuation and incontinence scores at 6, 18 and 24 months after surgery, morbidity, and overall survival represented secondary endpoints. Analysis was based on "per protocol" (PP) population, fully complying with trial requirements, and intention-to treat (ITT) population. RESULTS: Three hundred thirty-six patients from 15 hospitals were randomized. PP population included 257 patients (JCP = 63; SEA = 95; SCA = 99). Composite evacuation scores of PP and ITT populations did not show statistically significant differences among the 3 groups at any time point. Similarly, composite incontinence scores for PP and ITT populations showed no statistically significant difference among the 3 trial arms at any time point. CONCLUSIONS: Within boundaries of investigated procedures, surgeons in charge may continue to perform reconstruction of intestinal continuity following TME at their technical preference.
Authors: V Pla-Martí; J Martín-Arévalo; D Moro-Valdezate; S García-Botello; I Mora-Oliver; R Gadea-Mateo; C Cozar-Lozano; A Espí-Macías Journal: Tech Coloproctol Date: 2020-09-10 Impact factor: 3.781