The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis

NCT01515150 | Completed DMC

• 1 other identifier: P-VOD
• Study Type: observational
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

Previous multicentre study NCT 01008488 indicates that a patient with CT-proven uncomplicated diverticulitis has a very low risk (1.4%) of developing severe complications such as perforations or abscesses. The question is whether or not hospitalization is necessary, and if patients in that case could return home without antibiotics. The purpose of this study is to evaluate if out-patients managements in uncomplicated colonic diverticulitis is possible without readmission or complications.

Conditions

Colonic Diverticulitis

Keywords

diverticulitis; Out-patient management; Antibiotics

Outcome Measures

Primary Outcomes (1)

• Number of admission and complications among participant within three months follow-up.

  Three months

Secondary Outcomes (1)

• To evaluate reason of hospital admission, late complications, need of bowel rest and costs

  Three months

Study Arms (1)

Out-patients in diverticulitis

All patient with acute uncomplicated diverticulitis how accept participation in the study will be enrolled in the study.

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with CT- scan varified acute uncomplicated diverticulitis how are abel to underwent out-patients managment

You may qualify if:

• Adults (age above 18 years, acute abdominal pain (Duration\< 3 days), abdominal tenderness, elevated inflammatory parameters, CT- scan sign of uncomplicated diverticulitis(without sign of abscess or free air).

You may not qualify if:

• diffuse peritonitis sepsis or abscess, drying Patients who are unable to intake of fluids orally, severe pain with need of repeated parenteral morphine treatment, immunological deficient patients incl. steroid treatment, pregnancy, dementia, patients who need hospitalization of other reasons

Sponsors & Collaborators

• Uppsala University: lead

Study Sites (1)

Colorectal unit, department of surgery Västmanland Hospital Västerås

Västerås, Västmanland County, 72189, Sweden

Location

MeSH Terms

Conditions

Diverticulitis, Colonic; Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Diverticulosis, Colonic; Colonic Diseases; Intestinal Diseases

Study Officials

• Mats Enlund, Ass. Prof

  Centre of Clinical Research of Uppsala University, Västmanlands Hospital Västerås

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 18, 2012
• First Posted: January 23, 2012
• Study Start: February 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2014
• Last Updated: January 26, 2015

Record last verified: 2015-01

Locations

SE (1)