Laparoscopic peritoneal lavage versus sigmoidectomy for perforated diverticulitis with purulent peritonitis: three-year follow-up of the randomised LOLA trial
The LADIES trial collaborators
(2022) Surgical endoscopy, volume 36, issue 10, pp. 7764 - 7774
(Article)
Abstract
BACKGROUND: This study aimed to compare laparoscopic lavage and sigmoidectomy as treatment for perforated diverticulitis with purulent peritonitis during a 36 month follow-up of the LOLA trial. METHODS: Within the LOLA arm of the international, multicentre LADIES trial, patients with perforated diverticulitis with purulent peritonitis were randomised between laparoscopic lavage
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and sigmoidectomy. Outcomes were collected up to 36 months. The primary outcome of the present study was cumulative morbidity and mortality. Secondary outcomes included reoperations (including stoma reversals), stoma rates, and sigmoidectomy rates in the lavage group. RESULTS: Long-term follow-up was recorded in 77 of the 88 originally included patients, 39 were randomised to sigmoidectomy (51%) and 38 to laparoscopic lavage (49%). After 36 months, overall cumulative morbidity (sigmoidectomy 28/39 (72%) versus lavage 32/38 (84%), p = 0·272) and mortality (sigmoidectomy 7/39 (18%) versus lavage 6/38 (16%), p = 1·000) did not differ. The number of patients who underwent a reoperation was significantly lower for lavage compared to sigmoidectomy (sigmoidectomy 27/39 (69%) versus lavage 17/38 (45%), p = 0·039). After 36 months, patients alive with stoma in situ was lower in the lavage group (proportion calculated from the Kaplan-Meier life table, sigmoidectomy 17% vs lavage 11%, log-rank p = 0·0268). Eventually, 17 of 38 (45%) patients allocated to lavage underwent sigmoidectomy. CONCLUSION: Long-term outcomes showed that laparoscopic lavage was associated with less patients who underwent reoperations and lower stoma rates in patients alive after 36 months compared to sigmoidectomy. No differences were found in terms of cumulative morbidity or mortality. Patient selection should be improved to reduce risk for short-term complications after which lavage could still be a valuable treatment option.
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Keywords: Complicated diverticulitis, Laparoscopic lavage, Peritoneal Lavage/adverse effects, Diverticulitis/surgery, Follow-Up Studies, Diverticulitis, Colonic/complications, Humans, Laparoscopy/adverse effects, Peritonitis/etiology, Treatment Outcome, Intestinal Perforation/complications, Surgery, Research Support, Non-U.S. Gov't, Randomized Controlled Trial, Journal Article
ISSN: 0930-2794
Publisher: Springer New York
Note: Funding Information: The initial ladies trial and 12-month follow-up period was funded by Netherlands Organisation for Health Research and Development (ZonMw). No additional funding was used for the long-term follow-up. Funding Information: If requested, deidentified data collected for the LADIES trial, the study protocol, and informed consent form can be made available. Please contact WAB (w.a.bemelman@amsterdamumc.nl) or JF (j.lange@erasmusmc.nl), who will review all requests with the members of the Dutch Diverticular Disease (3D) Collaborative Study Group and the LADIES trial investigators. Requests should fulfil the following access criteria: research can only be conducted in collaboration with and after approval of the members of the 3D Collaborative Study Group and the LADIES trial investigators, and with a signed data access and sharing agreement. The members of the 3D Collaborative Study Group and the LADIES trial investigators must approve all research done with the shared data. The study was preregistered without an analysis plan, which can be assessed at ClinicalTrials.gov (NCT01317485). No preregistration exists for the reported second and third year data. The LADIES trial collaborators : W C Hop, B C Opmeer, J B Reitsma, R A Scholte, E W H Waltmann, A Legemate, J F Bartelsman, D W Meijer, M de Brouwer, J van Dalen, M Durbridge, M Geerdink, G J Ilbrink, S Mehmedovic, P Middelhoek, M J Boom (Department of Surgery, Flevo Hospital, Almere); E C J Consten, J D W van der Bilt, G D J van Olden, M A W Stam, M S Verweij (Department of Surgery, Meander Medical Centre, Amersfoort); Sandra Vennix, Gijsbert D Musters, Hilko A Swank, Marja A Boermeester, O R C Busch, C J Buskens, Y El-Massoudi, A B Kluit, C C van Rossem, M P Schijven, P J Tanis, C Unlu (Department of Surgery, Amsterdam University Medical Centre, University of Amsterdam, The Netherlands); Susan van Dieren (Clinical Research Unit, Amsterdam University Medical Centre, University of Amsterdam, The Netherlands); M F Gerhards, T M Karsten, L C de Nes, H Rijna (Department of Surgery, Onze Lieve Vrouwe Hospital, Amsterdam); B A van Wagensveld, G I Koff eman, E P Steller, J B Tuynman, (Department of Surgery, St Lucas Andreas Hospital, Amsterdam); S C Bruin (Department of Surgery, Slotervaart Hospital, Amsterdam); D L van der Peet (Department of surgery, VU Medical Center, Amsterdam); C F J M Blanken-Peeters (Department of Surgery, Rijnstate Hospital, Arnhem); H A Cense, E Jutte (Department of Surgery, Rode Kruis Hospital, Beverwijk); R M P H Crolla, G P van der Schelling, M van Zeeland (Department of Surgery, Amphia Hospital, Breda); E J R de Graaf, R P R Groenendijk (Department of Surgery, IJsselland Hospital, Capelle a/d IJssel); T M Karsten, M Vermaas, O Schouten, M R de Vries (Department of Surgery, Reinier de Graaf Hospital, Delft); H A Prins, D J Lips (Department of Surgery, Jeroen Bosch Hospital, Den Bosch); R J I Bosker (Department of Surgery, Deventer Hospital, Deventer); J A B van der Hoeven, J Diks, P W Plaisier (Department of Surgery, Albert Schweitzer Hospital, Dordrecht); P M Kruyt, C Sietses, M W J Stommel (Department of Surgery, Gelderse Vallei Hospital, Ede); S W Nienhuijs, I H J T de Hingh, M D P Luyer, G van Montfort, E H Ponten, J F Smulders (Department of Surgery, Catharina Hospital, Eindhoven); E B van Duyn, J M Klaase (Department of Surgery, Medical Spectrum Twente, Enschede); D J Swank, R T Ottow (Department of Surgery, Groene Hart Hospital, Gouda); H B A C Stockmann, J Vermeulen, R J C L M Vuylsteke (Department of Surgery, Kennemer Hospital, Haarlem); H J Belgers, S Fransen, E M von Meijenfeldt, M N Sosef (Department of Surgery, Atrium Medical Centre, Heerlen); A A W van Geloven, E R Hendriks, B ter Horst, M M N Leeuwenburgh, O van Ruler, J M Vogten, E J C Vriens, M Westerterp (Department of Surgery, Tergooi Hospital, Hilversum); Q A J Eijsbouts, A Bentohami, T S Bijlsma, N de Korte, D Nio (Department of Surgery, Spaarne Hospital, Hoofddorp); M J P M Govaert, J J A Joosten (Department of Surgery, Westfries Hospital, Hoorn); R A E M Tollenaar (Department of surgery, LUMC, Leiden); L P S Stassen (Department of Surgery, Maastricht University Medical Centre, Maastricht); M J Wiezer, E J Hazebroek, A B Smits, H L van Westreenen (Department of Surgery, St Antonius Hospital, Nieuwegein); J F Lange, A Brandt, W N Nijboer, Irene M Mulder (Department of Surgery, Erasmus Medical Centre University Hospital, Rotterdam); B R Toorenvliet, W F Weidema (Department of Surgery, Ikazia Hospital, Rotterdam); P P L O Coene (Department of Surgery, Maasstad Hospital, Rotterdam); G H H Mannaerts, D den Hartog, R J de Vos, J F Zengerink (Department of Surgery, St Franciscus Hospital, Rotterdam); A G M Hoofwijk, K W E Hulsewé, J Melenhorst, J H M B Stoot (Department of Surgery, Orbis Medical Centre, Sittard); W H Steup, P J Huijstee, J W S Merkus, J J Wever (Department of Surgery, Haga Hospital, The Hague); J K Maring, J Heisterkamp (Department of Surgery, Twee Steden Hospital, Tilburg); W M U van Grevenstein, M R Vriens, M G H Besselink, I H M Borel Rinkes, A J Witkamp (Department of Surgery, University Medical Centre, Utrecht); G D Slooter (Department of Surgery, Maxima Medical Centre, Veldhoven); J L M Konsten (Department of Surgery, VieCuri Hospital, Venlo); A F Engel (Department of Surgery, Zaans Medical Centre, Zaandam); E G J M Pierik, T G Frakking, D van Geldere, G A Patijn (Department of Surgery, Isala Hospital, Zwolle); Belgium A J L D’Hoore, A de Buck van Overstraeten, M Miserez, I Terrasson, A Wolthuis (Department of Surgery, University Hospital, Leuven); Italy S Di Saverio, M G De Blasiis (Department of Surgery, Hospital Maggiore, Bologna). WC Hop, BC Opmeer, JB Reitsma, RA Scholte, EWH Waltmann, A Legemate, JF Bartelsman, DW Meijer, M de Brouwer, J van Dalen, M Durbridge, M Geerdink, GJ Ilbrink, S Mehmedovic, P Middelhoek, MJ Boom, ECJ Consten, JDW van der Bilt, GDJ van Olden, MAW Stam, MS Verweij, Sandra Vennix, Gijsbert D Musters, Hilko A Swank, Marja A Boermeester, ORC Busch, CJ Buskens, Y El-Massoudi, AB Kluit, CC van Rossem, MP Schijven, PJ Tanis, C Unlu, Susan van Dieren, MF Gerhards, TM Karsten, LC de Nes, H Rijna, BA van Wagensveld, G I Koff eman, EP Steller, JB Tuynman, SC Bruin, DL van der Peet, CFJM Blanken-Peeters, HA Cense, E Jutte, RMPH Crolla, GP van der Schelling, M van Zeeland, EJR de Graaf, RPR Groenendijk, TM Karsten, M Vermaas, O Schouten, MR de Vries, HA Prins, DJ Lips, RJI Bosker, J A B van der Hoeven, J Diks, PW Plaisier, PM Kruyt, C Sietses, MWJ Stommel, SW Nienhuijs, IHJT de Hingh, MDP Luyer, G van Montfort, EH Ponten, JF Smulders, EB van Duyn, JM Klaase, DJ Swank, RT Ottow, HBAC Stockmann, J Vermeulen, RJCL M Vuylsteke, HJ Belgers, S Fransen, EM von Meijenfeldt, MN Sosef, AAW van Geloven, ER Hendriks, B ter Horst, MMN Leeuwenburgh, O van Ruler, JM Vogten, EJC Vriens, M Westerterp, QAJ Eijsbouts, A Bentohami, TS Bijlsma, N de Korte, D Nio, MJPM Govaert, J JA Joosten, RAEM Tollenaar, L P S Stassen, M J Wiezer, EJ Hazebroek, AB Smits, HL van Westreenen, JF Lange, A Brandt, WN Nijboer, Irene M Mulder, BR Toorenvliet, WF Weidema, PPLO Coene, GHH Mannaerts, D den Hartog, RJ de Vos, JF Zengerink, AGM Hoofwijk, K W E Hulsewé, J Melenhorst, JHMB Stoot, WH Steup, PJ Huijstee, JWS Merkus, JJ Wever, JK Maring, J Heisterkamp, WMU van Grevenstein, MR Vriens, MGH Besselink, IHM Borel Rinkes, AJ Witkamp, GD Slooter, JLM Konsten, AF Engel, EGJM Pierik, TG Frakking, D van Geldere, GA Patijn, BelgiumAJL D’Hoore, A de Buck van Overstraeten, M Miserez, I Terrasson, A Wolthuis, S di Saverio, MG de Blasiis Publisher Copyright: © 2022, The Author(s).
(Peer reviewed)
