The aim of this study is to evaluate clinical results and effect on health and well-being in patients operated for perforated diverticulitis with purulent peritonitis by laparoscopic lavage in Sweden when used outside of prospective studies/trials and in comparison with the traditional treatment, i.e. colon resection with or without stoma formation. A secondary aim is to evaluate the outcome after fecal peritonitis. The hypothesis is that laparoscopic lavage as treatment for perforated diverticulitis with purulent peritonitis is safe, efficient and cost saving, when used in routine health care.
Study Type
OBSERVATIONAL
Enrollment
669
Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3
Operation with colon resection for perforated diverticulitis Hinchey 4
Sahlgrenska University Hospital
Gothenburg, Västa Götaland, Sweden
Need for further surgical interventions within 12 months of index surgery
Number of patients in need of further surgical interventions within 12 months after index surgery.
Time frame: 12 months
Need for further surgical interventions within 24 months of index surgery
Number of patients in need of further surgical interventions within 24 months after index surgery.
Time frame: 24 months
Colon cancer diagnosis
Number of colon cancer diagnosis within 12 months
Time frame: 12 months
Health economics with regard to the two different treatment modalities.
In the analysis data from the study will be combined with prices from the cost-per-patient system at Sveriges Kommuner och Landsting, or where appropriate, from Sahlgrenska University Hospital, in combination with sensitivity testing of results.
Time frame: 2 years
Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively.
Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively in a national Swedish cohort and in routine health care.
Time frame: 36 months
Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.
Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.
Time frame: 90 days
Mortality (90 days and 12 months respectively).
Mortality (90 days and 12 months respectively).
Time frame: 12 months
Patient reported outcome after treatment for perforated diverticulitis, function
Patient reported outcome as measured using a disease specific questionnaire 2-3 years after index surgery. The questionnaire is developed specifically for this study and will address prevalence, severity and associated distress of symptoms using Likert-type scales regarding function after surgery for perforated diverticulitis.
Time frame: 3 years
Patient reported outcome after treatment for perforated diverticulitis, quality of life
Patient reported outcome using a questionnaire sent out 2-3 years after index surgery for perforated diverticulitis, using EQ-5D for quality of life.
Time frame: 3 years
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