Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

Peritonitis Caused by Perforated Left-sided Colon Diverticulitis Clinical Trial

Official title:

Hartmann vs Resection With Anastomosis and Diverting Stoma for Peritonitis Caused by Perforated Left-sided Colon Diverticulitis: a Multicenter Prospective Randomized Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01239927
• Other study ID #: PRTHRAPDP
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: November 12, 2010
• Last updated: November 12, 2010
• Start date: January 2000
• Est. completion date: July 2010

Study information

• Verified date: July 2010
• Source: Ente Ospedaliero Ospedali Galliera
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: National Bioethics Committee
• Study type: Interventional

Clinical Trial Summary

This prospective randomized trial is to prove the equivalence of primary sigmoid resection with end colostomy(Hartmann)(GROUP A) and primary sigmoid resection and immediate anastomosis with diverting stoma (GROUP B)with regard to morbidity and mortality in patients with peritonitis caused by perforated left-sided colon diverticulitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Intraoperative demonstrated peritonitis caused by perforated left-sided colon diverticulitis

Exclusion Criteria:

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diverticulitis
• Diverticulitis, Colonic
• Peritonitis
• Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

Intervention

Procedure:
• Primary sigmoid resection with end colostomy (Hartmann)

• Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)

Locations

Country	Name	City	State
Italy	Gian Andrea Binda	Genova

Sponsors (1)

Lead Sponsor	Collaborator
Ente Ospedaliero Ospedali Galliera

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	30-day mortality and morbidity after emergency surgery		30-day	Yes
Secondary	30-day mortality and morbidity after elective restoration of intestinal transit		30 day	Yes