Trial Outcomes & Findings for Recurrence Following Nonoperative Management of 1st Episode of Hinchey II Diverticulitis (NCT NCT01986686)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

107 participants

Primary outcome timeframe

Minimum of 1 year after enrollment

Results posted on

2017-10-18

Participant Flow

Participant milestones

Participant milestones
Measure	Observational The observation group will be followed clinically with no further intervention until the primary endpoint is reached.	Surgery The surgery group will be offered colon resection. Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease.
Overall Study STARTED	81	26
Overall Study COMPLETED	81	26
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Observational n=81 Participants The observation group will be followed clinically with no further intervention until the primary endpoint is reached.	Surgery n=26 Participants The surgery group will be offered colon resection. Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease.	Total n=107 Participants Total of all reporting groups
Age, Continuous	55.22 years STANDARD_DEVIATION 13.05 • n=81 Participants	53.31 years STANDARD_DEVIATION 13.51 • n=26 Participants	54.61 years STANDARD_DEVIATION 13.23 • n=107 Participants
Sex: Female, Male Female	30 Participants n=81 Participants	11 Participants n=26 Participants	41 Participants n=107 Participants
Sex: Female, Male Male	51 Participants n=81 Participants	15 Participants n=26 Participants	66 Participants n=107 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Observational n=81 Participants The observation group will be followed clinically with no further intervention until the primary endpoint is reached.	Surgery n=26 Participants The surgery group will be offered colon resection. Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease.
Primary Study Endpoint	26 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 4 years

Data will be collected on percent of patients who die during the follow-up period after enrollment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days

Data will be collected on percent and type of complications for the surgery arm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Data will be collected on recurrence and treatment for recurrent diverticulitis

Outcome measures

Outcome data not reported

Adverse Events

Observational

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Surgery

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Observational n=81 participants at risk The observation group will be followed clinically with no further intervention until the primary endpoint is reached.	Surgery n=26 participants at risk The surgery group will be offered colon resection. Colon resection: Elective robotic/laparoscopic/open colon resection for diverticular disease.
Gastrointestinal disorders Partial small bowel obstruction due to ileus	0.00% 0/81	3.8% 1/26 • Number of events 1
Infections and infestations Surgical site infection	0.00% 0/81	3.8% 1/26 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Roberto Bergamaschi, MD, PhD

Stony Brook Medicine

Phone: 631-638-2215

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place