A National, Registry Based Study of Clinical Results After Emergency Operation for Perforated Diverticulitis to Compare Laparoscopic Lavage and Resection Surgery in Routine Use.
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Perforated Diverticulitis
- Sponsor
- Sahlgrenska University Hospital, Sweden
- Enrollment
- 669
- Locations
- 1
- Primary Endpoint
- Need for further surgical interventions within 12 months of index surgery
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eva Haglind, MD, PhD, professor
MD, PhD, professor
Sahlgrenska University Hospital, Sweden
Eligibility Criteria
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-
- •No informed consent received or withdrawal of consent (questionnaire)
Outcomes
Primary Outcomes
Need for further surgical interventions within 12 months of index surgery
Time Frame: 12 months
Number of patients in need of further surgical interventions within 12 months after index surgery.
Secondary Outcomes
- Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.(90 days)
- Patient reported outcome after treatment for perforated diverticulitis, function(3 years)
- Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively.(36 months)
- Mortality (90 days and 12 months respectively).(12 months)
- Colon cancer diagnosis(12 months)
- Health economics with regard to the two different treatment modalities.(2 years)
- Patient reported outcome after treatment for perforated diverticulitis, quality of life(3 years)
- Need for further surgical interventions within 24 months of index surgery(24 months)