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CompletedNCT01239927Updated Nov 15, 2010

Hartmann vs R/A in Peritonitis by Perforated Diverticulitis

A Phase 2/3 interventional study of Primary sigmoid resection with end colostomy (Hartmann) and Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA) in Peritonitis Caused by Perforated Left-sided Colon Diverticulitis, sponsored by Ente Ospedaliero Ospedali Galliera. Completed at 1 site in Italy. Per ClinicalTrials.gov, last updated 2010-11-15.

Sponsored by Ente Ospedaliero Ospedali Galliera · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

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Keywords

  • diverticulitis
  • hartmann
  • anastomosis
03

In context

Diverticulitis

125 studies on the registry are indexed under Diverticulitis; 22 are open to participants now.

This study's enrollment of 100 is below the median of 120 across 63 interventional studies indexed under Diverticulitis.

Browse Diverticulitis studies →

Lead sponsor

Ente Ospedaliero Ospedali Galliera is the lead sponsor of 19 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Enrollment
100 participants (actual)

Interventions

  • ProcedurePrimary sigmoid resection with end colostomy (Hartmann)
  • ProcedurePrimary sigmoid resection and immediate anastomosis with diverting stoma (PRA)
06

What researchers measure

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

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Study locations

1 site
  • Gian Andrea Binda
    Genova, 16100, Italy
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 15, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01239927
Lead sponsor
Ente Ospedaliero Ospedali Galliera
First posted
Nov 15, 2010
Start date
Jan 2000
Primary completion
Jul 2010
Completion
Jul 2010
Last update
Nov 15, 2010

Study contacts

Roberto Bergamaschi, MD
study chair · Division of Colon & Rectal Surgery State University of New York Stony Brook, New York
Gian Andrea Binda
study director · EO Ospedali Galliera, Genova, Italy
Alberto Serventi
principal investigator · EO Ospedali Galliera, Genova, Italy

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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