Valerie Bridoux1, Jean Marc Regimbeau2, Mehdi Ouaissi3, Muriel Mathonnet4, Francois Mauvais5, Estelle Houivet6, Lilian Schwarz1, Diane Mege3, Igor Sielezneff3, Charles Sabbagh2, Jean-Jacques Tuech7. 1. Department of Digestive Surgery, Rouen University Hospital, Rouen, France. 2. Department of Digestive Surgery, Amiens University Hospital, Amiens, France. 3. Department of Digestive Surgery, Marseille University Hospital La Timone, Marseille, France. 4. Department of Digestive Surgery, Limoges University Hospital, Limoges, France. 5. Department of Digestive Surgery, Beauvais General Hospital, Beauvais, France. 6. Department of Biostatistics, Rouen University Hospital, Rouen, France. 7. Department of Digestive Surgery, Rouen University Hospital, Rouen, France. Electronic address: Jean-jacques.tuech@chu-rouen.fr.
Abstract
BACKGROUND: About 25% of patients with acute diverticulitis require emergency intervention. Currently, most patients with diverticular peritonitis undergo a Hartmann's procedure. Our objective was to assess whether primary anastomosis (PA) with a diverting stoma results in lower mortality rates than Hartmann's procedure (HP) in patients with diverticular peritonitis. STUDY DESIGN: We conducted a multicenter randomized controlled trial conducted between June 2008 and May 2012: the DIVERTI (Primary vs Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis) trial. Follow-up duration was up to 18 months. A random sample of 102 eligible participants with purulent or fecal diverticular peritonitis from tertiary care referral centers and associated centers in France were equally randomized to either a PA arm or to an HP arm. Data were analyzed on an intention-to-treat basis. The primary end point was mortality rate at 18 months. Secondary outcomes were postoperative complications, operative time, length of hospital stay, rate of definitive stoma, and morbidity. RESULTS:All 102 patients enrolled were comparable for age (p = 0.4453), sex (p = 0.2347), Hinchey stage III vs IV (p = 0.2347), and Mannheim Peritonitis Index (p = 0.0606). Overall mortality did not differ significantly between HP (7.7%) and PA (4%) (p = 0.4233). Morbidity for both resection and stoma reversal operations were comparable (39% in the HP arm vs 44% in the PA arm; p = 0.4233). At 18 months, 96% of PA patients and 65% of HP patients had a stoma reversal (p = 0.0001). CONCLUSIONS: Although mortality was similar in both arms, the rate of stoma reversal was significantly higher in the PA arm. This trial provides additional evidence in favor of PA with diverting ileostomy over HP in patients with diverticular peritonitis. ClinicalTrials.gov Identifier: NCT 00692393.
RCT Entities:
BACKGROUND: About 25% of patients with acute diverticulitis require emergency intervention. Currently, most patients with diverticular peritonitis undergo a Hartmann's procedure. Our objective was to assess whether primary anastomosis (PA) with a diverting stoma results in lower mortality rates than Hartmann's procedure (HP) in patients with diverticular peritonitis. STUDY DESIGN: We conducted a multicenter randomized controlled trial conducted between June 2008 and May 2012: the DIVERTI (Primary vs Secondary Anastomosis for Hinchey Stage III-IV Diverticulitis) trial. Follow-up duration was up to 18 months. A random sample of 102 eligible participants with purulent or fecal diverticular peritonitis from tertiary care referral centers and associated centers in France were equally randomized to either a PA arm or to an HP arm. Data were analyzed on an intention-to-treat basis. The primary end point was mortality rate at 18 months. Secondary outcomes were postoperative complications, operative time, length of hospital stay, rate of definitive stoma, and morbidity. RESULTS: All 102 patients enrolled were comparable for age (p = 0.4453), sex (p = 0.2347), Hinchey stage III vs IV (p = 0.2347), and Mannheim Peritonitis Index (p = 0.0606). Overall mortality did not differ significantly between HP (7.7%) and PA (4%) (p = 0.4233). Morbidity for both resection and stoma reversal operations were comparable (39% in the HP arm vs 44% in the PA arm; p = 0.4233). At 18 months, 96% of PApatients and 65% of HP patients had a stoma reversal (p = 0.0001). CONCLUSIONS: Although mortality was similar in both arms, the rate of stoma reversal was significantly higher in the PA arm. This trial provides additional evidence in favor of PA with diverting ileostomy over HP in patients with diverticular peritonitis. ClinicalTrials.gov Identifier: NCT 00692393.
Authors: M Sohn; A Agha; P Steiner; A Hochrein; J Pratschke; P Ritschl; F Aigner; I Iesalnieks Journal: World J Surg Date: 2019-05 Impact factor: 3.352