LAParoscopic LAVage (LapLav)

 

A national, registry based study of clinical results and of health and well-being in patients after emergency operation for perforated diverticulitis to study implementation of laparoscopic lavage and to compare outcomes with those of resection surgery in routine use. 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

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.

Endpoints

Primary:

  • Need for further surgical interventions within 12 and 24 months of index surgery.

Secondary:

  • Percentage of all cases treated by laparoscopic lavage and emergency colon resection, respectively.
  • Complications (Clavien-Dindo grade ≥ IIIa) within 90 days of index surgery.
  • Mortality (90 days and 12 months respectively).
  • Colon cancer diagnosis
  • Patient experience measured using a questionnaire 2-3 years after index surgery.
  • Health economic analysis.

For the secondary aim regarding fecal peritonitis the following endpoints will be evaluated:

  • Complications Clavien-Dindo ≥ IIIa within 90 days of index surgery.
  • Mortality.
  • Need for further surgical interventions within 12 and 24 months of index surgery.
  • Patient experience.

Inclusion/exclusion

Inclusion criteria:

All patients registered in the Patient registry with ICD 10 codes K57 classified as emergency admissions and with a 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).

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).

Exclusion criteria:

  • Patients where hospital records reveal that the index admission was misclassified (not perforated diverticulitis) will be excluded.
  • No informed consent received or withdrawal of consent (questionnaire).
  • Hinchey I and II.

Documents

Protocol (click on name to view/download): LapLav

Contact

Principal investigator:

Eva Haglind

Deputy principal investigator:

Mattias Prytz

Questions:

Doctoral student Andreas Samuelsson (andreas.samuelsson@vgregion.se) or research nurse Ingrid Höglund Karlsson (ingrid.hoglund-karlsson@vgregion.se)