Symptomatic Treatment of Acute Uncomplicated Diverticulitis | NCT02219698

Studies
Symptomatic Treatment of Acute Uncomplicated Diverticulitis

NCT02219698

Sponsor

Helsinki University Central Hospital

Status

Completed

Last Update Posted

Jul 31, 2015Estimated

Enrollment

158Estimated

Phase

Not Applicable

Conditions

Diverticulitis

Interventions

Ibuprofen
Paracetamol

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Jul 2015Actual

Completion Date

Not provided

First Submitted Date

Aug 11, 2014

First Submission Date that Met QC Criteria

Aug 18, 2014

First Posted Date

Aug 19, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2015

Last Update Posted Date

Jul 31, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ville Sallinen, M.D., Ph.D., Helsinki University Central HospitalPrincipal Investigator

Lead Sponsor

Helsinki University Central HospitalOTHER

Collaborators

Name	Class
Vatsatautien tutkimussäätiö - foundation	UNKNOWN
Mary and Georg Ehrnroot's foundation	UNKNOWN
Finnish Surgical society	UNKNOWN
Martti I. Turunen Foundation

Description Module

Brief Summary

The purpose of this study is to determine the safety and efficacy of symptomatic treatment (i.e. without antimicrobial drugs) of acute uncomplicated diverticulitis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

158Estimated

Label	Type	Description	Intervention Names
Symptomatic treatment	Experimental		Drug: Ibuprofen Drug: Paracetamol

Name	Type	Description	Arm Group Labels	Other Names
Ibuprofen	Drug		Symptomatic treatment
Paracetamol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Complications of diverticulitis	Incidence of complications of diverticulitis (abscess, free perforation, need for surgery)	30 days from allocation

Secondary Outcomes

Measure	Description	Time Frame
Length of hospital stay (days)		At the end of the hospital stay, an expected average of 2 days
Rate of re-admissions	Number patients re-admitted to hospital	30 days from discharge

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Computed tomography-diagnosed acute uncomplicated* diverticulitis
- No abscess, fistula, obstruction and distant intra- or retroperitoneal air. Pericolic air allowed.

Exclusion Criteria:

Already commenced antimicrobial medication
Immunosuppression (e.g. diabetes, corticosteroid medication, immunosuppressive medication, chemotherapy, chronic liver disease)
Suspicion of generalized peritonitis
Organ dysfunction
Another infection requiring antimicrobial medication
Pregnancy
Age < 18 years or > 90 years
Missing written consent

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Helsinki University Central Hospital		Helsinki		00029	Finland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
27145310	Derived	Mali JP, Mentula PJ, Leppaniemi AK, Sallinen VJ. Symptomatic Treatment for Uncomplicated Acute Diverticulitis: A Prospective Cohort Study. Dis Colon Rectum. 2016 Jun;59(6):529-34. doi: 10.1097/DCR.0000000000000579.

ID	Term
D000076385	Diverticular Diseases
D005759	Gastroenteritis
D005767	Gastrointestinal Diseases
D004066	Digestive System Diseases

ID	Term
D007052	Ibuprofen
D000082	Acetaminophen

ID	Term
D010666	Phenylpropionates
D000146	Acids, Carbocyclic
D002264	Carboxylic Acids
D009930	Organic Chemicals