Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis
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|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||Phase|
|Diverticulitis||Procedure: Colon resection||Not Applicable|
|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|
|Actual Primary Completion Date :||July 16, 2016|
|Actual 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|