Scandinavian Diverticulitis Trial SCANDIV-II (SCANDIV-II)

February 2, 2020 updated by: achabok, Uppsala University

Scandinavian Diverticulitis Trial SCANDIV II: Treatment of Acute Complicated Diverticulitis: a Prospective Observational Study

This study focuses on the treatment for complicated diverticulitis classified as Hinchey I-IV.

The aim of this prospective observational study is to evaluate type of treatment and the success rate of treatment in acute complicated diverticulitis (ACD) at participating hospitals in Sweden and Norway. Furthermore, the effects on quality of life for this patient group will be evaluated.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Diverticular disease is among the five most common gastrointestinal disorders. Among individuals with diverticulosis the lifetime risk of suffering from diverticulitis is between 4 and 25%. The most common complications of diverticulitis are perforation, abscess formation, fistula and obstruction. Emergency surgery is necessary in up to 25% of diverticulitis patients.

The American Society of Colon and Rectal Surgeon (ASCRS, 2014) recommends abscess drainage and antibiotic treatment and later elective surgery as treatment for complicated diverticulitis, Hinchey I and II (*) for abscesses larger or equal to 5 cm while others recommend resection surgery only for Hinchey II patients. The recommendations for surgery are motivated by the belief that surgical treatment will reduce the risk for relapsing disease with intra-abdominal/pelvic sepsis by more than 40%. However, these recommendations are based on small and out-dated retrospective studies.

Perforated diverticulitis with radiologically confirmed free intraperitoneal air is a life threatening disease with significant mortality and morbidity therefore several guidelines recommend acute surgical intervention. However, a conservative non-surgical approach for the treatment of perforated diverticulitis has been shown to be effective for hemodynamically stable patients with radiologically confirmed free air. A Swedish study recently showed the incidence of complicated diverticulitis to be 9/100.000 inhabitants/year of which about one third required acute surgical intervention. The most common operation in perforated diverticulitis is Hartman's procedure, which involves removal of the involved sigmoid segment, a terminal colostomy and blind closure of the rectal stump. Also primary resection of the sigmoid colon with anastomosis is frequently used, sometimes combined with a loop-ileostomy. Laparoscopic lavage without resection has emerged as an alternative operation method. However, the SCANDIV trial showed limitations of laparoscopic lavage with a higher frequency of re-operation in the lavage group compared to primary resection after 90 days. Nevertheless, several meta-analysis based on three randomized studies showed comparable rates regarding overall mortality and morbidity in laparoscopic lavage versus resection in perforated diverticulitis.

For patients with diverticulitis complicated by fistula (colovesical, colovaginal or colo cutaneous) surgery is the recommended treatment. This condition, however, rarely presents in an acute setting.

In Scandinavia a conservative approach restricted to antibiotics and percutaneous drainage is widely accepted as solitary treatment for patients with diverticular abscesses (Hinchey I and II). Also hemodynamically stable and non-immunocompromised patients with perforated diverticulitis (Hinchey III) are often managed conservatively with antibiotics and, if required, percutaneous drainage. Acute surgical intervention is performed if the condition of the patient deteriorates during hospital stay or if the CT shows signs of faecal peritonitis (Hinchey IV). Elective surgery for patients after an episode of acute complicated diverticulitis (Hinchey I-III) is usually reserved for patients with frequent relapses or with a persisting diverticular abscess.

However, some patients have frequent relapses with abscesses which are difficult to treat and suffer for a long time until the problem is solved. This clinical experience raises the question whether the Scandinavian treatment policy might be too conservative sometimes. Although elective surgery itself can lead to new complications and eventual deterioration in quality of life, early resection might be a better option for some patients. Also the quality of life for patients after conservative management of complicated diverticulitis has not been examined in detail previously.

* I Pericolic abscess II Distant/pelvic abscess III Generalized purulent peritonitis IV Faecal peritonitis

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients 18 years and older with complicated diverticulitis that are admitted to hospital. Diagnosis verified with computed tomography.

Description

Inclusion Criteria:

  • Age ≥18 years
  • Clinical symptoms and laboratory results suspicious for diverticulitis
  • CT findings of complicated diverticulitis with extraluminal air, presence of abscess with or without fistula or operative findings of complicated diverticulitis in an emergency setting

Exclusion Criteria:

  • patients with uncomplicated diverticulitis
  • unable to give informed consent.
  • language barrier

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Diverticulitis Hinchey I-IV
Patients with complicated diverticulitis (Hinchey I-IV) treated conservatively (iv antibiotics with or without percutaneous, transrectal or transvaginal drainage) or surgically.
Procedure: colon resection, stoma
oral or intravenous antibiotics treatment with or without percutanous or transrectal or transvaginal drainage
Other Names:
  • Conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Treatment in complicated diverticulitis
Time Frame: 1year
Surgery or conservative managment
1year
Treatment failure
Time Frame: 1year
Complications, reoperation, readmission, recurrence , mortality
1year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of guality of Life
Time Frame: 1 years
Quality of Life according to Short Health Scale Likert-scale.
1 years
Evaluation of guality of Life
Time Frame: 1 years
Quality of Life according to GIQLI.
1 years
Evaluation of guality of Life
Time Frame: 1 years
Quality of Life according to EQ5D.
1 years
Stoma
Time Frame: 1 year
Proportion of patients with Stoma
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Sahlgrenska University Hospital, Sweden
University Hospital, Linkoeping
Danderyd Hospital
Uppsala University Hospital
Stockholm South General Hospital
Centrallasarettet Västerås
Mora Hospital, Landstinget Dalarna

Investigators

  • Principal Investigator: Abbas Chabok, MD, PhD, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2018

Primary Completion (Anticipated)

April 10, 2022

Study Completion (Anticipated)

September 10, 2024

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

February 2, 2020

First Posted (Actual)

February 5, 2020

Study Record Updates

Last Update Posted (Actual)

February 5, 2020

Last Update Submitted That Met QC Criteria

February 2, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017/448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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