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

Completed

• Conditions: Perforated Diverticulitis
• Interventions: Procedure: Laparoscopic lavage; Procedure: Colon resection

• Registration Number: NCT03332550
• Lead Sponsor: Sahlgrenska University Hospital, Sweden

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-10
• Study First Submitted QC: 2017-11-01
• Study First Posted: 2017-11-06
• Study Start: 2018-04-18
• Primary Completion: 2020-12-31
• Study Completion: 2022-12-31
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-19
• Last Update Posted: 2023-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 669

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
purulent peritonitis	Laparoscopic lavage	Hinchey 3
faecal peritonitis	Colon resection	Hinchey 4
purulent peritonitis	Colon resection	Hinchey 3

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Colon cancer diagnosis	12 months	Number of colon cancer diagnosis within 12 months
Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.	90 days	Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.
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.
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.
Mortality (90 days and 12 months respectively).	12 months	Mortality (90 days and 12 months respectively).
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.
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.
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.

Trial Locations

Locations (1)

Sahlgrenska University Hospital; 🇸🇪 Gothenburg, Västa Götaland, Sweden