NCT01986686

Brief Summary

Patients will agree to be randomized to either surgery or observation following nonoperative management of a first episode of Hinchey II diverticulitis. Information will be collected on recurrence rates and major complications in both groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
107

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 9, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

November 18, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 16, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 16, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

October 18, 2017

Completed
Last Updated

October 18, 2017

Status Verified

May 1, 2017

Enrollment Period

4.8 years

First QC Date

August 9, 2013

Results QC Date

May 26, 2017

Last Update Submit

May 26, 2017

Conditions

Diverticulitis

Outcome Measures

Primary Outcomes (1)

  • Primary Study Endpoint

    The primary outcome measure is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.

    Minimum of 1 year after enrollment

Secondary Outcomes (5)

  • Measure Length of Hospital Stay for Surgery vs Non Surgery Patients

    4 years

  • Mortality

    4 years

  • Readmission

    30 days

  • Post Operative Complications

    30 days

  • Recurrence and Treatment

    2 years

Study Arms (2)

Observational

NO INTERVENTION

The observation group will be followed clinically with no further intervention until the primary endpoint is reached.

Surgery

ACTIVE COMPARATOR

The surgery group will be offered colon resection.

Procedure: Colon resection

Interventions

Colon resectionPROCEDURE

Elective robotic/laparoscopic/open colon resection for diverticular disease.

Surgery

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • older than or equal to 18
  • history of resolved first episode of diverticulitis with abscess (Hinchey class II) who were successfully treated by our standard protocol
  • the diagnosis confirmed by colonoscopy
  • Signed informed consent

You may not qualify if:

  • Prior episode of diverticulitis
  • Right sided diverticulitis
  • Failure of recovery from first episode, defined as recurrence within one month.
  • Cancer found at the site on screening colonoscopy
  • Comorbidities prohibiting surgery (as measured by colorectal POSSUM score)
  • Immunosuppressed patients
  • Hinchey I, III, or IV (diverticulitis with peritonitis and/or free air under the diaphragm)
  • Patients who are unable to sign the informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stony Brook Medicine

Stony Brook, New York, 11794, United States

Location

Related Publications (1)

  • You K, Bendl R, Taut C, Sullivan R, Gachabayov M, Bergamaschi R; Study Group on Diverticulitis. Randomized clinical trial of elective resection versus observation in diverticulitis with extraluminal air or abscess initially managed conservatively. Br J Surg. 2018 Jul;105(8):971-979. doi: 10.1002/bjs.10868. Epub 2018 Apr 23.

    PMID: 29683483DERIVED

MeSH Terms

Conditions

Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Results Point of Contact

Title
Roberto Bergamaschi, MD, PhD
Organization
Stony Brook Medicine
roberto.bergamaschi@stonybrookmedicine.edu
631-638-2215

Study Officials

  • Roberto C Bergamaschi, MD, PhD

    Stonybrook University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2013

First Posted

November 18, 2013

Study Start

October 1, 2011

Primary Completion

July 16, 2016

Study Completion

July 16, 2016

Last Updated

October 18, 2017

Results First Posted

October 18, 2017

Record last verified: 2017-05

Locations

US(1)