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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | No Intervention | The observation group will be followed clinically with no further intervention until the primary endpoint is reached. | |
| Surgery | Active Comparator | The surgery group will be offered colon resection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Colon resection | Procedure | Elective robotic/laparoscopic/open colon resection for diverticular disease. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Roberto C Bergamaschi, MD, PhD | Stonybrook University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stony Brook Medicine | Stony Brook | New York | 11794 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29683483 | Derived | You K, Bendl R, Taut C, Sullivan R, Gachabayov M, Bergamaschi R; Study Group on Diverticulitis. Randomized clinical trial of elective resection versus observation in diverticulitis with extraluminal air or abscess initially managed conservatively. Br J Surg. 2018 Jul;105(8):971-979. doi: 10.1002/bjs.10868. Epub 2018 Apr 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Observational | The observation group will be followed clinically with no further intervention until the primary endpoint is reached. |
| FG001 | Surgery | The surgery group will be offered colon resection. Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Observational | The observation group will be followed clinically with no further intervention until the primary endpoint is reached. |
| BG001 | Surgery | The surgery group will be offered colon resection. Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Minimum of 1 year after enrollment |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Observational | The observation group will be followed clinically with no further intervention until the primary endpoint is reached. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Partial small bowel obstruction due to ileus | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roberto Bergamaschi, MD, PhD | Stony Brook Medicine | 631-638-2215 | roberto.bergamaschi@stonybrookmedicine.edu |
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| ID | Term |
|---|---|
| D004238 | Diverticulitis |
| ID | Term |
|---|---|
| D000076385 | Diverticular Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | 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. | Not Posted | 4 years | Participants |
| Secondary | Mortality | Data will be collected on percent of patients who die during the follow-up period after enrollment. | Not Posted | 4 years | Participants |
| Secondary | Readmission | Data will be collected on percent of patients who are readmitted for recurrence or postoperative complications during the follow-up period after enrollment. | Not Posted | 30 days | Participants |
| Secondary | Post Operative Complications | Data will be collected on percent and type of complications for the surgery arm. | Not Posted | 30 days | Participants |
| Secondary | Recurrence and Treatment | Data will be collected on recurrence and treatment for recurrent diverticulitis | Not Posted | 2 years | Participants |
| 0 |
| 81 |
| 0 |
| 81 |
| EG001 | Surgery | The surgery group will be offered colon resection. Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease. | 2 | 26 | 0 | 26 |
| Surgical site infection | Infections and infestations | Systematic Assessment |
|
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