Abdominal InjuriesNCT02829125
Influence of Postoperative Rehabilitation and Pre- and Postoperative Physical Activity in Abdominal Surgery
An observational study of Abdominal Injuries, run by University Hospital, Strasbourg, France at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Abdominal Injuries
- How many people
- 400 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2015to Jan 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients undergoing abdominal surgery
Who may be able to join
- non-cancerous and cancerous pathology
- signed Consent
- Every patient operated on a scheduled or emergency abdominal surgery
Who cannot join
- inability to give informed about information
- minor Patient
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Service de Chirurgie Digestive - Hôpital de Hautepierre
Strasbourg, 67098
Jean-Philippe STEINMETZ, MD, 33 (0)3 88 12 72 56, Jean-Philippe.STEINMETZ@chru-strasbourg.fr
Benoît ROMAIN, MD, PhD, 33 (0)3 88 12 72 43, benoit.romain@chru-strasbourg.fr
About this study
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.
- Conditions
- Abdominal Injuries
- Keywords
- Early rehabilitation, abdominal surgery, ERAS
- Medical subject headings
- Abdominal Injuries
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life questionnaire
Measured: before and after the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study start1 Jan 2015
- Primary completion1 Jan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal InjuriesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Philippe STEINMETZ, MD, Study director, University Hospital, Strasbourg, FranceBenoît ROMAIN, MD, PhD, Principal investigator, University Hospital, Strasbourg, FranceSerge ROHR, MD, PHD, Principal investigator, University Hospital, Strasbourg, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829125
- Sponsor's protocol ID
- 6254
- Status last verified
- Jan 2015
- First submitted
- 17 Jun 2016
- Last updated
- 11 May 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Postoperative Rehabilitation and Pre- and Postoperative Physical Activity in Abdominal Surgery
- ClinicalTrials.gov ID
- NCT02829125
- Acronym / sponsor ID
- 6254
- Conditions
- Abdominal Injuries
- Keywords
- Early rehabilitation, abdominal surgery, ERAS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 1 Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing abdominal surgery
Key inclusion criteria (3 listed)
- non-cancerous and cancerous pathology
- signed Consent
- Every patient operated on a scheduled or emergency abdominal surgery
Key exclusion criteria (2 listed)
- inability to give informed about information
- minor Patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
quality of life questionnaire
Time frame: before and after the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Philippe STEINMETZ, MD study director
University Hospital, Strasbourg, France
Benoît ROMAIN, MD, PhD principal investigator
University Hospital, Strasbourg, France
Serge ROHR, MD, PHD principal investigator
University Hospital, Strasbourg, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Injuries, run by University Hospital, Strasbourg, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jean-Philippe STEINMETZ, MD (33 (0)3 88 12 72 56, Jean-Philippe.STEINMETZ@chru-strasbourg.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life questionnaire (time frame: before and after the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2017.