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NCT Number: NCT03332550

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

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.

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Key information

Conditions

Perforated Diverticulitis

Sex eligibility

All sexes

Study type

Observational

Primary location

Sahlgrenska University Hospital

Gothenburg, Västa Götaland, 413 45, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Laparoscopic lavage

Procedure

Operation with laparoscopic lavage for perforated diverticulitis Hinchey 3

Colon resection

Procedure

Operation with colon resection for perforated diverticulitis Hinchey 4

Primary outcomes

  1. 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

  1. Need for further surgical interventions within 24 months of index surgery

    Time frame: 24 months

    Number of patients in need of further surgical interventions within 24 months after index surgery.

  2. Colon cancer diagnosis

    Time frame: 12 months

    Number of colon cancer diagnosis within 12 months

  3. Health economics with regard to the two different treatment modalities.

    Time frame: 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.

  4. Percentages of all cases treated by laparoscopic lavage and emergency colon resection, respectively.

    Time frame: 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.

  5. Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.

    Time frame: 90 days

    Complications (Clavien-Dindo ≥ IIIa) within 90 days of index surgery.

  6. Mortality (90 days and 12 months respectively).

    Time frame: 12 months

    Mortality (90 days and 12 months respectively).

  7. Patient reported outcome after treatment for perforated diverticulitis, function

    Time frame: 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.

  8. Patient reported outcome after treatment for perforated diverticulitis, quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Sahlgrenska University Hospital

Other

Registry information

Official study title

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

Acronym: LapLav

Important dates

Study start
2018
Primary completion
2020
Study completion
2022
First posted
Nov 6, 2017
Registry last updated
Apr 20, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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