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OpenTrials
Completed

NCT Number: NCT01986686

Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis

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.

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Key information

Conditions

Diverticulitis Digestive System Diseases Diverticular Diseases Gastroenteritis Gastrointestinal Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Stony Brook Medicine

Stony Brook, New York, 11794, United States

About this study

This study will randomize patients with first episode of acute diverticulitis of the colon with extraluminal air and/or abscess as defined by CT scan following nonoperative management (NPO, IV antibiotics, percutaneous drainage, and TPN followed by colonoscopy) to observation or elective resection. The primary endpoint is recurrent diverticulitis of the colon defined as an acute episode confirmed at CT scan and requiring hospitalization with IV antibiotics.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Colon resection

Procedure

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

Primary outcomes

  1. Primary Study Endpoint

    Time frame: Minimum of 1 year after enrollment

    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.

Secondary outcomes

  1. Measure Length of Hospital Stay for Surgery vs Non Surgery Patients

    Time frame: 4 years

    Data collected will include length of hospital stay from the date of admission to discharge day for nonoperative management of the first episode of Hinchey II diverticulitis.

  2. Mortality

    Time frame: 4 years

    Data will be collected on percent of patients who die during the follow-up period after enrollment.

  3. Readmission

    Time frame: 30 days

    Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment.

  4. Post Operative Complications

    Time frame: 30 days

    Data will be collected on percent and type of complications for the surgery arm.

  5. Recurrence and Treatment

    Time frame: 2 years

    Data will be collected on recurrence and treatment for recurrent diverticulitis

Sponsors and collaborators

Lead sponsor

Stony Brook University

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Should Elective Resection Follow Nonoperative Management of First Episode of Diverticulitis of the Colon With Abscess and/or Extraluminal Air? A Randomized Controlled Trial.

Important dates

Study start
2011
Primary completion
2016
Study completion
2016
First posted
Nov 18, 2013
Registry last updated
Oct 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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