Diverticulitis
Conditions
Brief summary
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
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.
Interventions
PROCEDUREColon resection
Elective robotic/laparoscopic/open colon resection for diverticular disease.
Sponsors
Merck Sharp & Dohme LLC
Stony Brook University
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Study Endpoint | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Measure Length of Hospital Stay for Surgery vs Non Surgery Patients | 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 | 4 years | Data will be collected on percent of patients who die during the follow-up period after enrollment. |
| Readmission | 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 | 30 days | Data will be collected on percent and type of complications for the surgery arm. |
| Recurrence and Treatment | 2 years | Data will be collected on recurrence and treatment for recurrent diverticulitis |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Observational The observation group will be followed clinically with no further intervention until the primary endpoint is reached. | 81 |
| Surgery The surgery group will be offered colon resection.
Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease. | 26 |
| Total | 107 |
Baseline characteristics
| Characteristic | Observational | Surgery | Total |
|---|---|---|---|
| Age, Continuous | 55.22 years STANDARD_DEVIATION 13.05 | 53.31 years STANDARD_DEVIATION 13.51 | 54.61 years STANDARD_DEVIATION 13.23 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 30 Participants | 11 Participants | 41 Participants |
| Sex: Female, Male Male | 51 Participants | 15 Participants | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 81 | 0 / 26 |
| serious Total, serious adverse events | 0 / 81 | 2 / 26 |
Outcome results
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.
Time frame: Minimum of 1 year after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Observational | Primary Study Endpoint | 26 Participants |
| Surgery | Primary Study Endpoint | 2 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.
Time frame: 4 years
Secondary
Mortality
Data will be collected on percent of patients who die during the follow-up period after enrollment.
Time frame: 4 years
Secondary
Post Operative Complications
Data will be collected on percent and type of complications for the surgery arm.
Time frame: 30 days
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.
Time frame: 30 days
Secondary
Recurrence and Treatment
Data will be collected on recurrence and treatment for recurrent diverticulitis
Time frame: 2 years