NCT01789515

Brief Summary

In an attempt to reduce the risk for anastomotic leakage after low anterior resection it is common to create a diverting stoma at the same procedure. Several studies have shown that ERAS (Enhanced Recovery After Surgery)application reduces the risk of surgical stress and postoperative complications after major colorectal surgery. The aim of this study is to evaluate wether a diverting stoma, after low anterior resection for rectal cancer, affects postoperative morbidity in patients treated within an ERAS program.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
287

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2012

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

May 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 28, 2012

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 12, 2014

Status Verified

March 1, 2014

Enrollment Period

1.6 years

First QC Date

September 28, 2012

Last Update Submit

March 11, 2014

Conditions

LoopileostomyFast Track Program,(Enhanced Recovery After Surgery (ERAS))

Outcome Measures

Primary Outcomes (1)

  • Clinical anastomotic leakage

    Evaluate if a diverting stoma after low anterior resection affects postoperative Morbidity in patients treaated within an ERAS program

    0 to 9 years after surgery

Secondary Outcomes (1)

  • Permanent stoma

    0 to 9 years after surgery

Other Outcomes (1)

  • Total days of hospital stay

    0-9 years after surgery

Study Arms (1)

rectal cancer

Low Anterior Resection for Rectal Cancer

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Rectal cancer

You may qualify if:

  • all patients operated with low anterior resection for rectal cancer at Ersta Hospital between 2002 and 2011 registrated in ERAS database

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ersta Hospital

Stockholm, 116 91, Sweden

Location

Study Officials

  • Kajsa Anderin, MD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 28, 2012

First Posted

February 12, 2013

Study Start

May 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 12, 2014

Record last verified: 2014-03

Locations

SE(1)