NCT02829125

Brief Summary

The concept of early rehabilitation (ERAS: enhanced after-surgery recovery) was introduced by Kehlet et al. in 1995, as part of the colon surgery. This program is a support for patients combining laparoscopic surgery, epidural analgesia, early refeeding and rapid mobilization of patients. This strategy targets multiple elements (20 items) to support pre-, intra- and postoperative patients. This reduces the pain and the different organ dysfunction induced by surgical stress significantly decreasing length of hospital stay, postoperative morbidity and costs. Furthermore, early mobilization of patients is fundamental to the ERAS method. Few studies have analyzed the influence of preoperative exercise on postoperative rehabilitation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

June 17, 2016

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 12, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2018

Completed
Last Updated

May 11, 2017

Status Verified

January 1, 2015

Enrollment Period

3 years

First QC Date

June 17, 2016

Last Update Submit

May 10, 2017

Conditions

Abdominal Injuries

Keywords

Early rehabilitationabdominal surgeryERAS

Outcome Measures

Primary Outcomes (1)

  • quality of life questionnaire

    before and after the operation

Eligibility Criteria

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

patients undergoing abdominal surgery

You may qualify if:

  • non-cancerous and cancerous pathology
  • signed Consent
  • Every patient operated on a scheduled or emergency abdominal surgery

You may not qualify if:

  • inability to give informed about information
  • minor Patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Service de Chirurgie Digestive - Hôpital de Hautepierre

Strasbourg, 67098, France

RECRUITING

MeSH Terms

Conditions

Abdominal Injuries

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Officials

  • Jean-Philippe STEINMETZ, MD

    University Hospital, Strasbourg, France

    STUDY DIRECTOR

  • Benoît ROMAIN, MD, PhD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

  • Serge ROHR, MD, PHD

    University Hospital, Strasbourg, France

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jean-Philippe STEINMETZ, MD

CONTACT

33 (0)3 88 12 72 56Jean-Philippe.STEINMETZ@chru-strasbourg.fr

Benoît ROMAIN, MD, PhD

CONTACT

33 (0)3 88 12 72 43benoit.romain@chru-strasbourg.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2016

First Posted

July 12, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2018

Study Completion

January 1, 2018

Last Updated

May 11, 2017

Record last verified: 2015-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)