Hartmann's procedure versus sigmoidectomy with primary anastomosis for perforated diverticulitis with purulent or faecal peritonitis (LADIES): a multicentre, parallel-group, randomised, open-label, superiority trial.

Autor:	Lambrichts DPV; Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands; Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands. Electronic address: d.lambrichts@erasmusmc.nl., Vennix S; Department of Radiology, University Medical Centre Amsterdam, VUmc, Amsterdam, Netherlands., Musters GD; Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands., Mulder IM; Department of Surgery, Rode Kruis Hospital, Beverwijk, Netherlands., Swank HA; Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands., Hoofwijk AGM; Department of Surgery, Zuyderland Medical Centre, Sittard-Geleen, Netherlands., Belgers EHJ; Department of Surgery, Zuyderland Medical Centre, Sittard-Geleen, Netherlands., Stockmann HBAC; Department of Surgery, Spaarne Gasthuis, Haarlem, Netherlands., Eijsbouts QAJ; Department of Surgery, Spaarne Gasthuis, Haarlem, Netherlands., Gerhards MF; Department of Surgery, OLVG, Amsterdam, Netherlands., van Wagensveld BA; Department of Surgery, OLVG, Amsterdam, Netherlands., van Geloven AAW; Department of Surgery, Tergooi Hospital, Hilversum, Netherlands., Crolla RMPH; Department of Surgery, Amphia Hospital, Breda, Netherlands., Nienhuijs SW; Department of Surgery, Catharina Hospital, Eindhoven, Netherlands., Govaert MJPM; Department of Surgery, Dijklander Hospital, Hoorn, Netherlands., di Saverio S; Department of Surgery, Maggiore Hospital, Bologna, Italy; Cambridge Colorectal Unit, Addenbrooke's Hospital, Cambridge University Hospitals NHS Trust, Cambridge, UK., D'Hoore AJL; Department of Abdominal Surgery, University Hospitals, Leuven, Belgium., Consten ECJ; Department of Surgery, Meander Medical Centre, Amersfoort, Netherlands., van Grevenstein WMU; Department of Surgery, University Medical Centre Utrecht, Utrecht, Netherlands., Pierik REGJM; Department of Surgery, Isala Hospital, Zwolle, Netherlands., Kruyt PM; Department of Surgery, Gelderse Vallei Hospital, Ede, Netherlands., van der Hoeven JAB; Department of Surgery, Albert Schweitzer Hospital, Dordrecht, Netherlands., Steup WH; Department of Surgery, Haga Hospital, Den Haag, Netherlands., Catena F; Department of Surgery, Maggiore Hospital, Parma, Italy., Konsten JLM; Department of Surgery, VieCuri, Venlo, Netherlands., Vermeulen J; Department of Surgery, Maasstad Hospital, Rotterdam, Netherlands., van Dieren S; Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands., Bemelman WA; Department of Surgery, University Medical Centre Amsterdam, AMC, Amsterdam, Netherlands., Lange JF; Department of Surgery, Erasmus University Medical Centre, Rotterdam, Netherlands; Department of Surgery, IJsselland Hospital, Capelle aan den IJssel, Netherlands.
Jazyk:	angličtina
Zdroj:	The lancet. Gastroenterology & hepatology [Lancet Gastroenterol Hepatol] 2019 Aug; Vol. 4 (8), pp. 599-610. Date of Electronic Publication: 2019 Jun 06.
DOI:	10.1016/S2468-1253(19)30174-8
Abstrakt:	Background: Previous studies have suggested that sigmoidectomy with primary anastomosis is superior to Hartmann's procedure. The likelihood of stoma reversal after primary anastomosis has been reported to be higher and reversal seems to be associated with lower morbidity and mortality. Although promising, results from these previous studies remain uncertain because of potential selection bias. Therefore, this study aimed to assess outcomes after Hartmann's procedure versus sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy, for perforated diverticulitis with purulent or faecal peritonitis (Hinchey III or IV disease) in a randomised trial. Methods: A multicentre, randomised, open-label, superiority trial was done in eight academic hospitals and 34 teaching hospitals in Belgium, Italy, and the Netherlands. Patients aged between 18 and 85 years who presented with clinical signs of general peritonitis and suspected perforated diverticulitis were eligible for inclusion if plain abdominal radiography or CT scan showed diffuse free air or fluid. Patients with Hinchey I or II diverticulitis were not eligible for inclusion. Patients were allocated (1:1) to Hartmann's procedure or sigmoidectomy with primary anastomosis, with or without defunctioning ileostomy. Patients were enrolled by the surgeon or surgical resident involved, and secure online randomisation software was used in the operating room or by the trial coordinator on the phone. Random and concealed block sizes of two, four, or six were used, and randomisation was stratified by age (<60 and ≥60 years). The primary endpoint was 12-month stoma-free survival. Patients were analysed according to a modified intention-to-treat principle. The trial is registered with the Netherlands Trial Register, number NTR2037, and ClinicalTrials.gov, number NCT01317485. Findings: Between July 1, 2010, and Feb 22, 2013, and June 9, 2013, and trial termination on June 3, 2016, 133 patients (93 with Hinchey III disease and 40 with Hinchey IV disease) were randomly assigned to Hartmann's procedure (68 patients) or primary anastomosis (65 patients). Two patients in the Hartmann's group were excluded, as was one in the primary anastomosis group; the modified intention-to-treat population therefore consisted of 66 patients in the Hartmann's procedure group (46 with Hinchey III disease, 20 with Hinchey IV disease) and 64 in the primary anastomosis group (46 with Hinchey III disease, 18 with Hinchey IV disease). In 17 (27%) of 64 patients assigned to primary anastomosis, no stoma was constructed. 12-month stoma-free survival was significantly better for patients undergoing primary anastomosis compared with Hartmann's procedure (94·6% [95% CI 88·7-100] vs 71·7% [95% CI 60·1-83·3], hazard ratio 2·79 [95% CI 1·86-4·18]; log-rank p<0·0001). There were no significant differences in short-term morbidity and mortality after the index procedure for Hartmann's procedure compared with primary anastomosis (morbidity: 29 [44%] of 66 patients vs 25 [39%] of 64, p=0·60; mortality: two [3%] vs four [6%], p=0·44). Interpretation: In haemodynamically stable, immunocompetent patients younger than 85 years, primary anastomosis is preferable to Hartmann's procedure as a treatment for perforated diverticulitis (Hinchey III or Hinchey IV disease). Funding: Netherlands Organisation for Health Research and Development. (Copyright © 2019 Elsevier Ltd. All rights reserved.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu