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- Azhar, Najia, et al.
(författare)
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Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis: Long-term Outcomes From the Scandinavian Diverticulitis (SCANDIV) Randomized Clinical Trial
- 2021
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Ingår i: JAMA Surgery. - Chicago, IL, United States : American Medical Association. - 2168-6254 .- 2168-6262. ; 156:2, s. 121-127
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Tidskriftsartikel (refereegranskat)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-upwas 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 stagesINTERVENTIONS 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, 101were assigned to undergo laparoscopic peritoneal lavage and 98were assigned to colon resection. At the time of surgery, perforated purulent diverticulitiswas confirmed in 145 patients randomized to lavage (n = 74) and resection (n = 71). The median follow-upwas 59 (interquartile range, 51-78; full range, 0-110) months, and 3 patientswere 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 mortalitywas 32%(n = 23) in the laparoscopic lavage group and 25%(n = 17) in the resection group (P = .36). The stoma prevalencewas 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 diverticulitiswas 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. Therewere no significant differences in the EuroQoL-5Dquestionnaire 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.
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| 2. |
- Schultz, Johannes Kurt, et al.
(författare)
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Laparoscopic Lavage vs Primary Resection for Acute Perforated Diverticulitis : The SCANDIV Randomized Clinical Trial
- 2015
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Ingår i: Journal of the American Medical Association (JAMA). - : American Medical Association (AMA). - 0098-7484 .- 1538-3598. ; 314:13, s. 1364-1375
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Tidskriftsartikel (refereegranskat)abstract
- IMPORTANCE: Perforated colonic diverticulitis usually requires surgical resection, which is associated with significant morbidity. Cohort studies have suggested that laparoscopic lavage may treat perforated diverticulitis with less morbidity than resection procedures.OBJECTIVE: To compare the outcomes from laparoscopic lavage with those for colon resection for perforated diverticulitis.DESIGN, SETTING, AND PARTICIPANTS: Multicenter, randomized clinical superiority trial recruiting participants from 21 centers in Sweden and Norway from February 2010 to June 2014. The last patient follow-up was in December 2014 and final review and verification of the medical records was assessed in March 2015. Patients with suspected perforated diverticulitis, a clinical indication for emergency surgery, and free air on an abdominal computed tomography scan were eligible. Of 509 patients screened, 415 were eligible and 199 were enrolled.INTERVENTIONS: Patients were assigned to undergo laparoscopic peritoneal lavage (n = 101) or colon resection (n = 98) based on a computer-generated, center-stratified block randomization. All patients with fecal peritonitis (15 patients in the laparoscopic peritoneal lavage group vs 13 in the colon resection group) underwent colon resection. Patients with a pathology requiring treatment beyond that necessary for perforated diverticulitis (12 in the laparoscopic lavage group vs 13 in the colon resection group) were also excluded from the protocol operations and treated as required for the pathology encountered.MAIN OUTCOMES AND MEASURES: The primary outcome was severe postoperative complications (Clavien-Dindo score >IIIa) within 90 days. Secondary outcomes included other postoperative complications, reoperations, length of operating time, length of postoperative hospital stay, and quality of life.RESULTS: The primary outcome was observed in 31 of 101 patients (30.7%) in the laparoscopic lavage group and 25 of 96 patients (26.0%) in the colon resection group (difference, 4.7% [95% CI, -7.9% to 17.0%]; P = .53). Mortality at 90 days did not significantly differ between the laparoscopic lavage group (14 patients [13.9%]) and the colon resection group (11 patients [11.5%]; difference, 2.4% [95% CI, -7.2% to 11.9%]; P = .67). The reoperation rate was significantly higher in the laparoscopic lavage group (15 of 74 patients [20.3%]) than in the colon resection group (4 of 70 patients [5.7%]; difference, 14.6% [95% CI, 3.5% to 25.6%]; P = .01) for patients who did not have fecal peritonitis. The length of operating time was significantly shorter in the laparoscopic lavage group; whereas, length of postoperative hospital stay and quality of life did not differ significantly between groups. Four sigmoid carcinomas were missed with laparoscopic lavage.CONCLUSIONS AND RELEVANCE: Among patients with likely perforated diverticulitis and undergoing emergency surgery, the use of laparoscopic lavage vs primary resection did not reduce severe postoperative complications and led to worse outcomes in secondary end points. These findings do not support laparoscopic lavage for treatment of perforated diverticulitis.TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT01047462.
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