Laparoscopic Lavage for Perforated Diverticulitis With Purulent Peritonitis: A Randomized Trial.

BACKGROUND: Perforated diverticulitis with purulent peritonitis has traditionally been treated with open colon resection and stoma formation with risk for reoperations, morbidity, and mortality. Laparoscopic lavage alone has been suggested as definitive treatment. OBJECTIVE: To compare laparoscopic lavage with open colon resection and colostomy (Hartmann procedure) for perforated diverticulitis with purulent peritonitis. DESIGN: Randomized, controlled, multicenter, open-label trial. (ISRCTN registry number: ISRCTN82208287). SETTING: 9 hospitals in Sweden and Denmark. PATIENTS: Patients who have confirmed Hinchey grade III perforated diverticulitis with purulent peritonitis at diagnostic laparoscopy. INTERVENTION: Randomization between laparoscopic lavage and the Hartmann procedure. MEASUREMENTS: Primary outcome was the percentage of patients having 1 or more reoperations within 12 months. Key secondary outcomes were number of reoperations, hospital readmissions, total length of hospital stay during 12 months, and adverse events. RESULTS: A total of 43 and 40 patients were randomly assigned to laparoscopic lavage and the Hartmann procedure with a median (first, third quartiles) follow-up of 372 days (336, 394) and 378 days (226, 396), respectively. Fewer patients in the laparoscopic group (12 of 43; 27.9%) than in the Hartmann group (25 of 40; 62.5%) had at least 1 reoperation within 12 months (relative risk reduction, 59%; relative risk, 0.41 [95% CI, 0.23 to 0.72]; P = 0.004). Mortality and severe adverse events did not differ between groups. Total length of hospital stay (days) within 12 months was shorter for the laparoscopic group than the Hartmann group, with a reduction of 35% (relative risk, 0.65 [CI, 0.45 to 0.94]; P = 0.047). After 12 months, 3 patients in the laparoscopic group and 11 in the Hartmann group had a stoma. LIMITATION: Not all patients presenting with suspected diverticulitis were enrolled. CONCLUSION: Laparoscopic lavage reduced the need for reoperations, had a similar safety profile to the Hartmann procedure, and may be an appropriate treatment of choice for acute perforated diverticulitis with purulent peritonitis. PRIMARY FUNDING SOURCE: ALF; Sahlgrenska University Hospital, Gothenburg.

Laparoscopic Lavage Is Feasible and Safe for the Treatment of Perforated Diverticulitis With Purulent Peritonitis: The First Results From the Randomized Controlled Trial DILALA.

OBJECTIVE: To evaluate short-term outcomes of a new treatment for perforated diverticulitis with purulent peritonitis in a randomized controlled trial. BACKGROUND: Perforated diverticulitis with purulent peritonitis (Hinchey III) has traditionally been treated with surgery including colon resection and stoma (Hartmann procedure) with considerable postoperative morbidity and mortality. Laparoscopic lavage has been suggested as a less invasive surgical treatment. METHODS: Laparoscopic lavage was compared with colon resection and stoma in a randomized controlled multicenter trial, DILALA (ISRCTN82208287). Initial diagnostic laparoscopy showing Hinchey III was followed by randomization. Clinical data was collected up to 12 weeks postoperatively. RESULTS: Eighty-three patients were randomized, out of whom 39 patients in laparoscopic lavage and 36 patients in the Hartmann procedure groups were available for analysis. Morbidity and mortality after laparoscopic lavage did not differ when compared with the Hartmann procedure. Laparoscopic lavage resulted in shorter operating time, shorter time in the recovery unit, and shorter hospital stay. CONCLUSIONS: In this trial, laparoscopic lavage as treatment for patients with perforated diverticulitis Hinchey III was feasible and safe in the short-term.

Application of 3D Printing in Training Health Care Providers; the Development of Diverse Facial Overlays for Simulation-Based Medical Training.

The medical simulation manikins used by healthcare learners provide the training of numerous clinical skills but often lack diversity with respect to race, ethnicity, age, and sex. Having a diverse medical education environment is imperative for exposing learners to the diverse population of patients they may encounter when in practice. In this technical report, the development of diverse and cost-effective facial overlays produced using 3D scanning, 3D printing, and silicone to be used on top of the current medical manikins at Lakeridge Health Hospital (Oshawa, Ontario, Canada) is described. To obtain consistent feedback throughout the development process, an advisory committee was consulted monthly at Lakeridge Health Hospital. The process began by determining that two facial overlays would be developed based on the two groups that represent the highest percentage of visible minorities in the Durham Region (Ontario, Canada). Facial overlays representing the South Asian (31.8%) and Black (29.6%) races were chosen. To prevent the generalizability of the facial features of these two races, volunteers who identified as specific ethnicities (East Indian and Jamaican) within each race were selected. To add variation in age for the facial overlays, the East Indian facial overlay was edited to represent an adolescent teenager (15 to 17 years old) and the Jamaican overlay was edited to represent an elderly citizen (over 60 years old). The facial overlays were developed from the 3D scans of the two volunteers and were used to create the design of 3D printed molds, in which silicone was poured in. Pigments were added to the silicone to match the skin tones of the two volunteers, and these specific tones were used as the base color for each facial overlay. Details, such as wrinkles, eyebrows, and lip color, were painted on top of the base using additional pigmented silicone. Additionally, neck overlays were created to provide continuity of the skin tone of the facial overlay. To retain the functionality of the medical manikins, the eyes of the facial overlays were cut out, and the mouth was cut open to allow for intubation training. For stability purposes, Velcro attachments were added to the facial and neck overlays so that they could be secured onto the medical manikins. Overall, the costs to manufacture both facial overlays resulted in CAD 235.65, including local taxes. Once manufactured, both facial overlays were tested by medical students (n=18) during two separate advanced cardiovascular life support (ACLS) training sessions in the local, hospital-based simulation laboratory at Lakeridge Health Hospital. The feedback obtained suggested a need to improve the functionality of the facial overlays by making the mouths bigger and less stiff for easier intubation. However, the overlays were accepted overall as a means to add diversity to the current medical manikins. In the end, cost-effective and diverse facial overlays were created to be used on top of the medical manikins that are currently being used by healthcare learners at Lakeridge Health Hospital.

Assessing health, quality of life and urogenital function in a sample of the Swedish general population: a cross-sectional study.

OBJECTIVE: Evaluate the urinary, bowel and sexual function as well as stress symptoms and depression in a sample of the Swedish population. DESIGN: A random sample of Swedish men and women in age groups from 30 to 89 years, a total of 3000 individuals, were contacted and after receiving informed consent, a questionnaire was sent. MAIN OUTCOME MEASURES: Measures of urinary, bowel, sexual function and quality of life. RESULTS: The questionnaire was sent to 2094 individuals who gave informed consent. The questionnaire was answered by 1078 individuals. Quality of life, stress symptoms and depressed mood were relatively constant across age groups for both men and women. Urinary function differed significantly across gender and age groups, but bowel function was relatively unaffected by age. Overall bowel dysfunction was slightly more prevalent among women compared with men. For both men and women, the frequency of intercourse or other sexual activities decreased with age, whereas sexually associated distress increased by age in men, but decreased among women. CONCLUSIONS: In a general population, the urinary function varied across age and sex. Overall bowel dysfunction was slightly more prevalent among women compared with men. Sexually associated distress increased by age for men, but decreased for women. TRIAL REGISTRATION NUMBER: NCT02392923; Results.

Self-reported quality of life and functional outcome in patients with rectal cancer--QoLiRECT.

INTRODUCTION: The treatment of rectal cancer has improved, and survival rates today exceed those of colon cancer, but functional impairments and other adverse effects of treatment are common among patients. The impact of treatment on patients' quality of life (QoL) remains unclear. Many of the common QoL instruments are brief and not sufficiently detailed to provide a deeper understanding of the factors that determine QoL. The aim of this study was to explore patients' experiences and long-term QoL in an unselected cohort of patients with rectal cancer. METHODS: This is a prospective international multicentre study based on a comprehensive, validated questionnaire on functional impairments and QoL administered to an unselected population of 1,500 patients with rectal cancer at diagnosis and after one, two and five years. The clinical characteristics are retrieved from the national quality registers. A total of 14 hospitals in Sweden and Denmark are currently involved in the study. Inclusion is ongoing, and new including hospitals are welcome to join. Full accrual is expected within two years. CONCLUSION: This study will provide detailed knowledge about the challenges that patients face following diagnosis and treatment of rectal cancer. It will investigate the nature, severity and perceived significance of constraints and symptoms, as well as the impact of a variety of clinical and patient-related factors on QoL. The study will probably identify areas where changes in care routines may improve patients' QoL. FUNDING: This study was supported by the Swedish Research Council, grant number 2012-1768; the Swedish Cancer Society CAN 2010/593 and CAN 2013/500; the Swedish Society of Medicine; the Gothenburg Medical Society; the Health & Medical Care Committee of the Regional Executive Board, Region Västra Götaland; ALF grant 138751 and 136151, "Agreement concerning research and education of doctors"; Anna-Lisa and Bror Björnsson Foundation; Assar Gabrielsson Foundation; Mary von Sydow Foundation; Ruth and Richard Julin's Foundation and Lion's Cancer Research Foundation of Western Sweden. TRIAL REGISTRATION: ClinicalTrials.gov (NCT01477229).

Treatment of acute diverticulitis laparoscopic lavage vs. resection (DILALA): study protocol for a randomised controlled trial.

BACKGROUND: Perforated diverticulitis is a condition associated with substantial morbidity. Recently published reports suggest that laparoscopic lavage has fewer complications and shorter hospital stay. So far no randomised study has published any results. METHODS: DILALA is a Scandinavian, randomised trial, comparing laparoscopic lavage (LL) to the traditional Hartmann's Procedure (HP). Primary endpoint is the number of re-operations within 12 months. Secondary endpoints consist of mortality, quality of life (QoL), re-admission, health economy assessment and permanent stoma. Patients are included when surgery is required. A laparoscopy is performed and if Hinchey grade III is diagnosed the patient is included and randomised 1:1, to either LL or HP. Patients undergoing LL receive > 3L of saline intraperitoneally, placement of pelvic drain and continued antibiotics. Follow-up is scheduled 6-12 weeks, 6 months and 12 months. A QoL-form is filled out on discharge, 6- and 12 months. Inclusion is set to 80 patients (40+40). DISCUSSION: HP is associated with a high rate of complication. Not only does the primary operation entail complications, but also subsequent surgery is associated with a high morbidity. Thus the combined risk of treatment for the patient is high. The aim of the DILALA trial is to evaluate if laparoscopic lavage is a safe, minimally invasive method for patients with perforated diverticulitis Hinchey grade III, resulting in fewer re-operations, decreased morbidity, mortality, costs and increased quality of life. TRIAL REGISTRATION: British registry (ISRCTN) for clinical trials ISRCTN82208287http://www.controlled-trials.com/ISRCTN82208287.