Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
|ClinicalTrials.gov Identifier: NCT01986686|
Recruitment Status : Completed
First Posted : November 18, 2013
Results First Posted : October 18, 2017
Last Update Posted : October 18, 2017
|Condition or disease||Intervention/treatment|
|Diverticulitis||Procedure: Colon resection|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||107 participants|
|Intervention Model:||Sequential Assignment|
|Masking:||None (Open Label)|
|Official 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.|
|Study Start Date :||October 2011|
|Primary Completion Date :||July 16, 2016|
|Study Completion Date :||July 16, 2016|
No Intervention: Observational
The observation group will be followed clinically with no further intervention until the primary endpoint is reached.
Active Comparator: Surgery
The surgery group will be offered colon resection.
Procedure: Colon resection
Elective robotic/laparoscopic/open colon resection for diverticular disease.
- 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.
- 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.
- Mortality [ Time Frame: 4 years ]Data will be collected on percent of patients who die during the follow-up period after enrollment.
- 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.
- Post Operative Complications [ Time Frame: 30 days ]Data will be collected on percent and type of complications for the surgery arm.
- Recurrence and Treatment [ Time Frame: 2 years ]Data will be collected on recurrence and treatment for recurrent diverticulitis
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986686
|United States, New York|
|Stony Brook Medicine|
|Stony Brook, New York, United States, 11794|
|Principal Investigator:||Roberto C Bergamaschi, MD, PhD||Stonybrook University|