Perforated Diverticulitis
Conditions
Keywords
laparoscopic lavage
Brief summary
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.
Interventions
PROCEDURELaparoscopic lavage
Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3
PROCEDUREColon resection
Operation with colon resection for perforated diverticulitis Hinchey 4
Sponsors
Sahlgrenska University Hospital
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All patients registered in the Patient registry with ICD 10 codes K57 classified as emergency admissions and with the Nordic Medico-Statistical Committee (NOMESCO) code JAH01(diagnostic laparoscopy), JFB46 (resection of sigmoid colon), JFB60 (resection of sigmoid colon, sigmoidostomy and closure of the distal stump), JFB61 (laparoscopic resection of sigmoid colon, sigmoidostomy and closure of the distal stump), JFB63 (other colon resection, colostomy and closure of the distal stump), JAK04 (laparoscopy and peritoneal lavage), JAW97 (other laparoscopic operation involving abdominal wall, mesentery, peritoneum or the omentum)
Exclusion criteria
* Patients where hospital records reveal that the index admission was misclassified (not perforated diverticulitis) will be excluded. * Patients classified as Hinchey 1-2. * No informed consent received or withdrawal of consent (questionnaire)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Need for further surgical interventions within 12 months of index surgery | 12 months | Number of patients in need of further surgical interventions within 12 months after index surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Colon cancer diagnosis | 12 months | Number of colon cancer diagnosis within 12 months |
| Health economics with regard to the two different treatment modalities. | 2 years | 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. |
| Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively. | 36 months | Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively in a national Swedish cohort and in routine health care. |
| Need for further surgical interventions within 24 months of index surgery | 24 months | Number of patients in need of further surgical interventions within 24 months after index surgery. |
| Mortality (90 days and 12 months respectively). | 12 months | Mortality (90 days and 12 months respectively). |
| Patient reported outcome after treatment for perforated diverticulitis, function | 3 years | 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. |
| Patient reported outcome after treatment for perforated diverticulitis, quality of life | 3 years | Patient reported outcome using a questionnaire sent out 2-3 years after index surgery for perforated diverticulitis, using EQ-5D for quality of life. |
| Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery. | 90 days | Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery. |
Countries
Sweden
Outcome results
None listed