NCT01986686

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 107 (actual)
• Sponsor: Stony Brook University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diverticulitis

Interventions

Type	Name	Description
PROCEDURE	Colon resection	Elective robotic/laparoscopic/open colon resection for diverticular disease.

Timeline

• Start date: 2011-10-01
• Primary completion: 2016-07-16
• Completion: 2016-07-16
• First posted: 2013-11-18
• Last updated: 2017-10-18
• Results posted: 2017-10-18

Locations

1 site across 1 country: United States