ClinicalTrials.gg
CompletedNCT01515150P-VODUpdated Jan 26, 2015

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

An observational study in Colonic Diverticulitis, sponsored by Uppsala University. Completed at 1 site in Sweden. Open to participants aged 18 Years to 95 Years. Per ClinicalTrials.gov, last updated 2015-01-26.

Sponsored by Uppsala University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
161
Ages
18 Years to 95 Years
Sex
All
01

Study 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.

Read the detailed description

At the emergency room all patients with computed tomography verified acute uncomplicated diverticulitis will be asked about participation in the study. If They accept the participation, They will be send home with pain relief medicine. Every morning a nurse from our colorectal unit call the patient asking about the condition. The patients will have a visit at the surgery unit within 10 days.

02

Conditions studied

  • Colonic Diverticulitis

Keywords

  • diverticulitis
  • Out-patient management
  • Antibiotics
03

In context

Diverticulitis, Colonic

27 studies on the registry are indexed under Diverticulitis, Colonic; 8 are open to participants now.

This study's enrollment of 161 is below the median of 250 across 15 observational studies indexed under Diverticulitis, Colonic.

Browse Diverticulitis, Colonic studies →

Lead sponsor

Uppsala University is the lead sponsor of 390 studies on the registry; 86 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 95 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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).

Exclusion criteria

Exclusion Criteria:

  • 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. treatment, pregnancy, dementia, patients who need hospitalization of other reasons
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
161 participants (actual)
Patient registry
No

Groups and cohorts

  • Out-patients in diverticulitis

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

06

What researchers measure

Primary outcomes

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

    Time frame: Three months

Secondary outcomes

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

    Time frame: Three months

07

Study locations

1 site
  • Colorectal unit, department of surgery Västmanland Hospital Västerås
    Västerås, Västmanland 72189, Sweden
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2012, a primary completion of Dec 2013 and a completion of Aug 2014. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 18, 2012
First posted
Jan 23, 2012
Start
Feb 2012
Primary completionActual
Dec 2013
CompletionActual
Aug 2014
Last update
Jan 26, 2015
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01515150
Lead sponsor
Uppsala University
Responsible party
Sponsor
First posted
Jan 23, 2012
Start date
Feb 2012
Primary completion
Dec 2013
Completion
Aug 2014
Last update
Jan 26, 2015

Study contacts

Mats Enlund, Ass. Prof
study chair · Centre of Clinical Research of Uppsala University, Västmanlands Hospital Västerås

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2015. You cannot join it, but the record below documents what was studied.

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