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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986686
Recruitment Status : Completed
First Posted : November 18, 2013
Results First Posted : October 18, 2017
Last Update Posted : October 18, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Stony Brook University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Sequential Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Diverticulitis
Intervention Procedure: Colon resection
Enrollment 107
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Observational Surgery
Hide Arm/Group Description The observation group will be followed clinically with no further intervention until the primary endpoint is reached.

The surgery group will be offered colon resection.

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

Period Title: Overall Study
Started 81 26
Completed 81 26
Not Completed 0 0
Arm/Group Title Observational Surgery Total
Hide Arm/Group Description The observation group will be followed clinically with no further intervention until the primary endpoint is reached.

The surgery group will be offered colon resection.

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

Total of all reporting groups
Overall Number of Baseline Participants 81 26 107
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 81 participants 26 participants 107 participants
55.22  (13.05) 53.31  (13.51) 54.61  (13.23)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 81 participants 26 participants 107 participants
Female
30
  37.0%
11
  42.3%
41
  38.3%
Male
51
  63.0%
15
  57.7%
66
  61.7%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Primary Study Endpoint
Hide Description 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.
Time Frame Minimum of 1 year after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Observational Surgery
Hide Arm/Group Description:
The observation group will be followed clinically with no further intervention until the primary endpoint is reached.

The surgery group will be offered colon resection.

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

Overall Number of Participants Analyzed 81 26
Measure Type: Count of Participants
Unit of Measure: Participants
26
  32.1%
2
   7.7%
2.Secondary Outcome
Title Measure Length of Hospital Stay for Surgery vs Non Surgery Patients
Hide Description 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.
Time Frame 4 years
Outcome Measure Data Not Reported
3.Secondary Outcome
Title Mortality
Hide Description Data will be collected on percent of patients who die during the follow-up period after enrollment.
Time Frame 4 years
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Readmission
Hide Description Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment.
Time Frame 30 days
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Post Operative Complications
Hide Description Data will be collected on percent and type of complications for the surgery arm.
Time Frame 30 days
Outcome Measure Data Not Reported
6.Secondary Outcome
Title Recurrence and Treatment
Hide Description Data will be collected on recurrence and treatment for recurrent diverticulitis
Time Frame 2 years
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Observational Surgery
Hide Arm/Group Description The observation group will be followed clinically with no further intervention until the primary endpoint is reached.

The surgery group will be offered colon resection.

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

All-Cause Mortality
Observational Surgery
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Hide Serious Adverse Events
Observational Surgery
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/81 (0.00%)      2/26 (7.69%)    
Gastrointestinal disorders     
Partial small bowel obstruction due to ileus   0/81 (0.00%)  0 1/26 (3.85%)  1
Infections and infestations     
Surgical site infection   0/81 (0.00%)  0 1/26 (3.85%)  1
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Observational Surgery
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/81 (0.00%)      0/26 (0.00%)    
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Roberto Bergamaschi, MD, PhD
Organization: Stony Brook Medicine
Phone: 631-638-2215
EMail: roberto.bergamaschi@stonybrookmedicine.edu
Layout table for additonal information
Responsible Party: Stony Brook University
ClinicalTrials.gov Identifier: NCT01986686    
Other Study ID Numbers: RCB1956
First Submitted: August 9, 2013
First Posted: November 18, 2013
Results First Submitted: May 26, 2017
Results First Posted: October 18, 2017
Last Update Posted: October 18, 2017