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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Diverticulitis

Intervention / Treatment
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* Procedure: Colon resection


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Observational<br>The observation group will be followed clinically with no further intervention until the primary endpoint is reached. | |
| Active Comparator: Surgery<br>The surgery group will be offered colon resection. | Procedure: Colon resection<br>* Elective robotic/laparoscopic/open colon resection for diverticular disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure Length of Hospital Stay for Surgery vs Non Surgery Patients | 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. | 4 years | 
| Mortality | Data will be collected on percent of patients who die during the follow-up period after enrollment. | 4 years | 
| Readmission | Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment. | 30 days | 
| Post Operative Complications | Data will be collected on percent and type of complications for the surgery arm. | 30 days | 
| Recurrence and Treatment | Data will be collected on recurrence and treatment for recurrent diverticulitis | 2 years |