A National Study of Clinical Results After Emergency Operation for Perforated Diverticulitis

Study Overview
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Brief Summary
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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.

Official Title
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A National, Registry Based Study of Clinical Results After Emergency Operation for Perforated Diverticulitis to Compare Laparoscopic Lavage and Resection Surgery in Routine Use.

Conditions
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Perforated Diverticulitis

Intervention / Treatment
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* Procedure: Laparoscopic lavage
* Procedure: Colon resection


Participation Criteria
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Eligibility Criteria
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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)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| purulent peritonitis<br>Hinchey 3 | Procedure: Laparoscopic lavage<br>* Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3<br>Procedure: Colon resection<br>* Operation with colon resection for perforated diverticulitis Hinchey 4<br>|
| faecal peritonitis<br>Hinchey 4 | Procedure: Colon resection<br>* Operation with colon resection for perforated diverticulitis Hinchey 4<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 24 months | 
| Colon cancer diagnosis | Number of colon cancer diagnosis within 12 months | 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. | 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. | 36 months | 
| Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery. | Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery. | 90 days | 
| Mortality (90 days and 12 months respectively). | Mortality (90 days and 12 months respectively). | 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. | 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. | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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laparoscopic lavage