Najia Azhar1,2, Anette Johanssen3, Tove Sundström2, Joakim Folkesson4, Conny Wallon5,6, Hartvig Kørner7,8, Ljiljana Blecic9, Håvard Mjørud Forsmo10, Tom Øresland11, Sheraz Yaqub12, Pamela Buchwald1,2, Johannes Kurt Schultz3. 1. Department of Surgery, Skåne University Hospital, Malmö, Sweden. 2. Department of Clinical Sciences Malmö, Lund University, Lund, Sweden. 3. Department of Digestive Surgery, Akershus University Hospital, Lørenskog, Norway. 4. Department of Surgical Sciences, Uppsala University, Uppsala, Sweden. 5. Department of Surgery, Linköping University, Linköping, Sweden. 6. Department of Clinical and Experimental Medicine, Linköping University, Linköping, Sweden. 7. Department of Gastrointestinal Surgery, Stavanger University Hospital, Stavanger, Norway. 8. Department of Clinical Medicine, University of Bergen, Bergen, Norway. 9. Department of Gastrointestinal Surgery, Østfold Hospital, Fredrikstad, Norway. 10. Department of Gastrointestinal and Emergency Surgery, Haukeland University Hospital, Bergen, Norway. 11. Faculty of Medicine, University of Oslo, Oslo, Norway. 12. Department of Gastrointestinal Surgery, Oslo University Hospital, Oslo, Norway.
Abstract
Importance: Perforated colonic diverticulitis usually requires surgical resection, with significant morbidity. Short-term results from randomized clinical trials have indicated that laparoscopic lavage is a feasible alternative to resection. However, it appears that no long-term results are available. Objective: To compare long-term (5-year) outcomes of laparoscopic peritoneal lavage and primary resection as treatments of perforated purulent diverticulitis. Design, Setting, and Participants: This international multicenter randomized clinical trial was conducted in 21 hospitals in Sweden and Norway, which enrolled patients between February 2010 and June 2014. Long-term follow-up was conducted between March 2018 and November 2019. Patients with symptoms of left-sided acute perforated diverticulitis, indicating urgent surgical need and computed tomography-verified free air, were eligible. Those available for trial intervention (Hinchey stages <IV) were included in the long-term follow-up. Interventions: Patients were assigned to undergo laparoscopic peritoneal lavage or colon resection based on computer-generated, center-stratified block randomization. Main Outcomes and Measures: The primary outcome was severe complications within 5 years. Secondary outcomes included mortality, secondary operations, recurrences, stomas, functional outcomes, and quality of life. Results: Of 199 randomized patients, 101 were assigned to undergo laparoscopic peritoneal lavage and 98 were assigned to colon resection. At the time of surgery, perforated purulent diverticulitis was confirmed in 145 patients randomized to lavage (n = 74) and resection (n = 71). The median follow-up was 59 (interquartile range, 51-78; full range, 0-110) months, and 3 patients were lost to follow-up, leaving a final analysis of 73 patients who had had laparoscopic lavage (mean [SD] age, 66.4 [13] years; 39 men [53%]) and 69 who had received a resection (mean [SD] age, 63.5 [14] years; 36 men [52%]). Severe complications occurred in 36% (n = 26) in the laparoscopic lavage group and 35% (n = 24) in the resection group (P = .92). Overall mortality was 32% (n = 23) in the laparoscopic lavage group and 25% (n = 17) in the resection group (P = .36). The stoma prevalence was 8% (n = 4) in the laparoscopic lavage group vs 33% (n = 17; P = .002) in the resection group among patients who remained alive, and secondary operations, including stoma reversal, were performed in 36% (n = 26) vs 35% (n = 24; P = .92), respectively. Recurrence of diverticulitis was higher following laparoscopic lavage (21% [n = 15] vs 4% [n = 3]; P = .004). In the laparoscopic lavage group, 30% (n = 21) underwent a sigmoid resection. There were no significant differences in the EuroQoL-5D questionnaire or Cleveland Global Quality of Life scores between the groups. Conclusions and Relevance: Long-term follow-up showed no differences in severe complications. Recurrence of diverticulitis after laparoscopic lavage was more common, often leading to sigmoid resection. This must be weighed against the lower stoma prevalence in this group. Shared decision-making considering both short-term and long-term consequences is encouraged. Trial Registration: ClinicalTrials.gov Identifier: NCT01047462.
Importance: Perforated colonic diverticulitis usually requires surgical resection, with significant morbidity. Short-term results from randomized clinical trials have indicated that laparoscopic lavage is a feasible alternative to resection. However, it appears that no long-term results are available. Objective: To compare long-term (5-year) outcomes of laparoscopic peritoneal lavage and primary resection as treatments of perforated purulent diverticulitis. Design, Setting, and Participants: This international multicenter randomized clinical trial was conducted in 21 hospitals in Sweden and Norway, which enrolled patients between February 2010 and June 2014. Long-term follow-up was conducted between March 2018 and November 2019. Patients with symptoms of left-sided acute perforated diverticulitis, indicating urgent surgical need and computed tomography-verified free air, were eligible. Those available for trial intervention (Hinchey stages <IV) were included in the long-term follow-up. Interventions: Patients were assigned to undergo laparoscopic peritoneal lavage or colon resection based on computer-generated, center-stratified block randomization. Main Outcomes and Measures: The primary outcome was severe complications within 5 years. Secondary outcomes included mortality, secondary operations, recurrences, stomas, functional outcomes, and quality of life. Results: Of 199 randomized patients, 101 were assigned to undergo laparoscopic peritoneal lavage and 98 were assigned to colon resection. At the time of surgery, perforated purulent diverticulitis was confirmed in 145 patients randomized to lavage (n = 74) and resection (n = 71). The median follow-up was 59 (interquartile range, 51-78; full range, 0-110) months, and 3 patients were lost to follow-up, leaving a final analysis of 73 patients who had had laparoscopic lavage (mean [SD] age, 66.4 [13] years; 39 men [53%]) and 69 who had received a resection (mean [SD] age, 63.5 [14] years; 36 men [52%]). Severe complications occurred in 36% (n = 26) in the laparoscopic lavage group and 35% (n = 24) in the resection group (P = .92). Overall mortality was 32% (n = 23) in the laparoscopic lavage group and 25% (n = 17) in the resection group (P = .36). The stoma prevalence was 8% (n = 4) in the laparoscopic lavage group vs 33% (n = 17; P = .002) in the resection group among patients who remained alive, and secondary operations, including stoma reversal, were performed in 36% (n = 26) vs 35% (n = 24; P = .92), respectively. Recurrence of diverticulitis was higher following laparoscopic lavage (21% [n = 15] vs 4% [n = 3]; P = .004). In the laparoscopic lavage group, 30% (n = 21) underwent a sigmoid resection. There were no significant differences in the EuroQoL-5D questionnaire or Cleveland Global Quality of Life scores between the groups. Conclusions and Relevance: Long-term follow-up showed no differences in severe complications. Recurrence of diverticulitis after laparoscopic lavage was more common, often leading to sigmoid resection. This must be weighed against the lower stoma prevalence in this group. Shared decision-making considering both short-term and long-term consequences is encouraged. Trial Registration: ClinicalTrials.gov Identifier: NCT01047462.
Authors: Silvia Moler-Zapata; Richard Grieve; David Lugo-Palacios; A Hutchings; R Silverwood; Luke Keele; Tommaso Kircheis; David Cromwell; Neil Smart; Robert Hinchliffe; Stephen O'Neill Journal: Med Decis Making Date: 2022-05-24 Impact factor: 2.749
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Authors: Paola Fugazzola; Marco Ceresoli; Federico Coccolini; Francesco Gabrielli; Alessandro Puzziello; Fabio Monzani; Bruno Amato; Gabriele Sganga; Massimo Sartelli; Francesco Menichetti; Gabriele Adolfo Puglisi; Dario Tartaglia; Paolo Carcoforo; Nicola Avenia; Yoram Kluger; Ciro Paolillo; Mauro Zago; Ari Leppäniemi; Matteo Tomasoni; Lorenzo Cobianchi; Francesca Dal Mas; Mario Improta; Ernest E Moore; Andrew B Peitzman; Michael Sugrue; Vanni Agnoletti; Gustavo P Fraga; Dieter G Weber; Dimitrios Damaskos; Fikri M Abu-Zidan; Imtiaz Wani; Andrew W Kirkpatrick; Manos Pikoulis; Nikolaos Pararas; Edward Tan; Richard Ten Broek; Ronald V Maier; R Justin Davies; Jeffry Kashuk; Vishal G Shelat; Alain Chicom Mefire; Goran Augustin; Stefano Magnone; Elia Poiasina; Belinda De Simone; Massimo Chiarugi; Walt Biffl; Gian Luca Baiocchi; Fausto Catena; Luca Ansaloni Journal: World J Emerg Surg Date: 2022-01-21 Impact factor: 5.469