NCT01391169

Brief Summary

This is a control matched prospective study evaluating the use of seromuscular flap for high risk anastomoses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2009

Typical duration for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 6, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 11, 2011

Completed
Last Updated

July 11, 2011

Status Verified

April 1, 2009

Enrollment Period

2 years

First QC Date

July 6, 2011

Last Update Submit

July 8, 2011

Conditions

Peritonitis

Outcome Measures

Primary Outcomes (1)

  • anastomotic leak

    5 weeks

Secondary Outcomes (2)

  • operative time

    2 hours

  • wound complications

    5 weeks

Study Arms (2)

1sup group

ACTIVE COMPARATOR

enforcement of the anastomoses with seromuscular flap

Other: seromuscular flap enforcement

2nd group

PLACEBO COMPARATOR

primary anastomosis without enforcement

Other: seromuscular flap enforcement

Interventions

seromuscular flap enforcementOTHER

seromuscular flap enforcement

Also known as: primary anastomosis only
1sup group2nd group

Eligibility Criteria

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

You may qualify if:

  • all patients with high risk anastomoses

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University

Al Mansurah, Mansoura, 35516, Egypt

Location

MeSH Terms

Conditions

Peritonitis

Condition Hierarchy (Ancestors)

Intraabdominal InfectionsInfectionsPeritoneal DiseasesDigestive System Diseases

Study Officials

  • ramadan ellithy, MD

    Mansoura University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 6, 2011

First Posted

July 11, 2011

Study Start

April 1, 2009

Primary Completion

April 1, 2011

Study Completion

June 1, 2011

Last Updated

July 11, 2011

Record last verified: 2009-04

Locations

EG(1)