NCT01239927

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2000

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2000

Completed
10.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 15, 2010

Completed
Last Updated

November 15, 2010

Status Verified

July 1, 2010

Enrollment Period

10.5 years

First QC Date

November 12, 2010

Last Update Submit

November 12, 2010

Conditions

Peritonitis Caused by Perforated Left-sided Colon Diverticulitis

Keywords

diverticulitishartmannanastomosis

Outcome Measures

Primary Outcomes (1)

  • 30-day mortality and morbidity after emergency surgery

    30-day

Secondary Outcomes (1)

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

    30 day

Interventions

Primary sigmoid resection with end colostomy (Hartmann)PROCEDURE
Primary sigmoid resection and immediate anastomosis with diverting stoma (PRA)PROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gian Andrea Binda

Genova, Genova, 16100, Italy

Location

MeSH Terms

Conditions

Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular DiseasesGastroenteritisGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Roberto Bergamaschi, MD

    Division of Colon & Rectal Surgery State University of New York Stony Brook, New York

    STUDY CHAIR

  • Gian Andrea Binda

    EO Ospedali Galliera, Genova, Italy

    STUDY DIRECTOR

  • Alberto Serventi

    EO Ospedali Galliera, Genova, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 12, 2010

First Posted

November 15, 2010

Study Start

January 1, 2000

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

November 15, 2010

Record last verified: 2010-07

Locations

IT(1)