| Title: |
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 |
| Authors: |
Lambrichts DPV; Vennix S; Musters GD; Mulder IM; Swank HA; Hoofwijk AGM; Belgers EHJ; Stockmann HBAC; Eijsbouts QAJ; Gerhards MF; van Wagensveld BA; van Geloven AAW; Crolla RMPH; Nienhuijs SW; Govaert MJPM; di Saverio S; D'Hoore AJL; Consten ECJ; van Grevenstein WMU; Pierik REGJM; Kruyt PM; van der Hoeven JAB; Steup WH; Catena F; Konsten JLM; Vermeulen J; van Dieren S; Bemelman WA; Lange JF; LADIES trial collaborators |
| Contributors: |
Lambrichts, Dpv; Vennix, S; Musters, Gd; Mulder, Im; Swank, Ha; Hoofwijk, Agm; Belgers, Ehj; Stockmann, Hbac; Eijsbouts, Qaj; Gerhards, Mf; van Wagensveld, Ba; van Geloven, Aaw; Crolla, Rmph; Nienhuijs, Sw; Govaert, Mjpm; di Saverio, S; D'Hoore, Ajl; Consten, Ecj; van Grevenstein, Wmu; Pierik, Regjm; Kruyt, Pm; van der Hoeven, Jab; Steup, Wh; Catena, F; Konsten, Jlm; Vermeulen, J; van Dieren, S; Bemelman, Wa; Lange, Jf; LADIES trial, Collaborators |
| Publication Year: |
2019 |
| Collection: |
IRInSubria - Institutional Repository Insubria (Università degli Studi dell’Insubria) |
| Subject Terms: |
Aged; Anastomosis; Surgical; Colon; Sigmoid; Colostomy; Diverticulitis; Colonic; Female; Human; Ileostomy; Intestinal Perforation; Male; Middle Aged; Peritoniti; Postoperative Complication; Rectum; Treatment Outcome; Proctectomy |
| Description: |
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 ( |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
info:eu-repo/semantics/altIdentifier/pmid/31178342; info:eu-repo/semantics/altIdentifier/wos/WOS:000477757200023; volume:4; issue:8; firstpage:599; lastpage:610; journal:THE LANCET. GASTROENTEROLOGY & HEPATOLOGY; https://hdl.handle.net/11383/2088214 |
| DOI: |
10.1016/S2468-1253(19)30174-8 |
| Availability: |
https://hdl.handle.net/11383/2088214; https://doi.org/10.1016/S2468-1253(19)30174-8 |
| Accession Number: |
edsbas.E59DC4D0 |
| Database: |
BASE |