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Completed

NCT Number: NCT01239927

Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

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.

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Key information

Conditions

Peritonitis Caused by Perforated Left-sided Colon Diverticulitis Digestive System Diseases Diverticular Diseases Diverticulitis Gastroenteritis Gastrointestinal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Gian Andrea Binda

Genova, 16100, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

Treatment and study plan

Primary sigmoid resection with end colostomy (Hartmann)

Procedure

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

Procedure

Primary outcomes

  1. 30-day mortality and morbidity after emergency surgery

    Time frame: 30-day

Secondary outcomes

  1. 30-day mortality and morbidity after elective restoration of intestinal transit

    Time frame: 30 day

Sponsors and collaborators

Lead sponsor

Ente Ospedaliero Ospedali Galliera

Other

Registry information

Official study title

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

Important dates

Study start
2000
Primary completion
2010
Study completion
2010
First posted
Nov 15, 2010
Registry last updated
Nov 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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