TY - JOUR
T1 - Hartmann's procedure versus sigmoidectomy with primary anastomosis for perforated diverticulitis with purulent or fecal peritonitis
T2 - Three-year follow-up of a randomised controlled trial
AU - LADIES Trial Collaborators
AU - Edomskis, Pim P.
AU - Hoek, Vincent T.
AU - Stark, Pieter W.
AU - Lambrichts, Daniël P.V.
AU - Draaisma, Werner A.
AU - Consten, Esther C.J.
AU - Bemelman, Willem A.
AU - Lange, Johan F.
N1 - Funding Information:
No funding was received for this long-term follow-up. However, short term follow-up was funded by the Netherlands Organisation for Health Research and Development (ZonMw) .
Publisher Copyright:
© 2022 The Authors
PY - 2022/2
Y1 - 2022/2
N2 - Background: The aim of the present study is to present the three years follow-up a randomised controlled trial that compared Hartmann's Procedure (HP) with sigmoidectomy with primary anastomosis (with or without defunctioning ileostomy) (PA) in a randomised design to determine the optimal treatment strategy for perforated diverticulitis with purulent or fecal peritonitis.Methods: Data were prospectively gathered for the first 12 months after randomization and retrospectively collected up to 36 months. The primary long-term endpoint was stoma free rate 36 months after the index procedure. Secondary outcomes were patients with a stoma at 36 months, percentage of stoma reversals, related reinterventions, parastomal/incisional hernia rates, total in hospital days including all readmissions regardless their relation to the intervention, overall morbidity and mortality.Results: Three years follow-up was completed in 119 of the originally 130 included patients, with 57 (48%) in the PA-group and 62 (52%) patients in the HP-group. 36 months stoma free rate was significantly better for patients undergoing PA compared with HP (PA 92% vs HP 81%, hazard ratio 2.326 [95% CI 1.538–3.517]; log-rank p < 0·0001). Stoma reversal rates did not significantly differ (PA 31/40(78%) versus HP 45/61(74%), p = 0.814). Overall cumulative morbidity (PA 21/57(36%) versus HP 30/62(48%), p = 0.266) and mortality (PA 6/57(11%) versus HP 7/62 (11%), p = 1.000) did not differ between groups. However, more parastomal hernias occurred in the HP-group (HP 10/62(16%) vs PA 1/57(2%), p = 0.009) and the mean total in hospital days after three years follow-up was significantly lower in the PA-group compared to the HP-group (PA 14 days (IQR 9.5–22.5) versus HP 17 days (IQR 12.5–27.5)), p = 0.025).Conclusion: Long-term results showed that in haemodynamically stable, immunocompetent patients primary anastomosis is superior to Hartmann's procedure as treatment for perforated diverticulitis with respect to long-term stoma free rate, overall hospitalization and parastomal hernias.
AB - Background: The aim of the present study is to present the three years follow-up a randomised controlled trial that compared Hartmann's Procedure (HP) with sigmoidectomy with primary anastomosis (with or without defunctioning ileostomy) (PA) in a randomised design to determine the optimal treatment strategy for perforated diverticulitis with purulent or fecal peritonitis.Methods: Data were prospectively gathered for the first 12 months after randomization and retrospectively collected up to 36 months. The primary long-term endpoint was stoma free rate 36 months after the index procedure. Secondary outcomes were patients with a stoma at 36 months, percentage of stoma reversals, related reinterventions, parastomal/incisional hernia rates, total in hospital days including all readmissions regardless their relation to the intervention, overall morbidity and mortality.Results: Three years follow-up was completed in 119 of the originally 130 included patients, with 57 (48%) in the PA-group and 62 (52%) patients in the HP-group. 36 months stoma free rate was significantly better for patients undergoing PA compared with HP (PA 92% vs HP 81%, hazard ratio 2.326 [95% CI 1.538–3.517]; log-rank p < 0·0001). Stoma reversal rates did not significantly differ (PA 31/40(78%) versus HP 45/61(74%), p = 0.814). Overall cumulative morbidity (PA 21/57(36%) versus HP 30/62(48%), p = 0.266) and mortality (PA 6/57(11%) versus HP 7/62 (11%), p = 1.000) did not differ between groups. However, more parastomal hernias occurred in the HP-group (HP 10/62(16%) vs PA 1/57(2%), p = 0.009) and the mean total in hospital days after three years follow-up was significantly lower in the PA-group compared to the HP-group (PA 14 days (IQR 9.5–22.5) versus HP 17 days (IQR 12.5–27.5)), p = 0.025).Conclusion: Long-term results showed that in haemodynamically stable, immunocompetent patients primary anastomosis is superior to Hartmann's procedure as treatment for perforated diverticulitis with respect to long-term stoma free rate, overall hospitalization and parastomal hernias.
KW - Complicated diverticulitis
KW - Hartmann's procedure
KW - long-term;therapy
KW - Primary anastomosis
KW - Stoma free rate
KW - Surgery
U2 - 10.1016/j.ijsu.2021.106221
DO - 10.1016/j.ijsu.2021.106221
M3 - Article
C2 - 35026462
AN - SCOPUS:85123726562
SN - 1743-9191
VL - 98
JO - International Journal of Surgery
JF - International Journal of Surgery
M1 - 106221
ER -