An observational study in Perforated Diverticulitis, sponsored by Sahlgrenska University Hospital. Completed at 1 site in Sweden. Per ClinicalTrials.gov, last updated 2023-04-20.
Sponsored by Sahlgrenska University Hospital · Observational
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.
125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.
This study's enrollment of 669 is above the median of 275 across 59 observational studies indexed under Diverticulitis.
Browse Diverticulitis studies →Sahlgrenska University Hospital is the lead sponsor of 263 studies on the registry; 68 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All swedish patients registrered within the Swedish Patient Registry with ICD 10 codes K57 classified as emergency admissions and with a NOMESCO code JAH01, JFB46 , JFB60, JFB61, JFB63, JAK04, JAW97.
The cohort will be divided into two groups when analysing and presenting results, perforated diverticulitis with purulent peritonitis (Hinchey grade III) and perforated diverticulitis with faecal peritonitis (Hinchey grade IV) .
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hinchey 3
Procedure: Laparoscopic lavage · Procedure: Colon resection
Hinchey 4
Procedure: Colon resection
Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3
Operation with colon resection for perforated diverticulitis Hinchey 4
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
Plan to share: No
This study is completed, as verified in Apr 2023. You cannot join it, but the record below documents what was studied.
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