Digestive and Urological SurgeryUPOG-DIGUNCT06448494
Evaluation of the New Peri-Operative Geriatric Units in Ile-de-France, in Digestive and Urological Surgery
An observational study of Digestive and Urological Surgery, run by Gérond'if at 1 site in France.
Trial summary
The main objective of this study is to evaluate the effectiveness of experimental management by digestive or urological "new Peri-Operative Geriatric Units", on post-operative follow-up in the 3 months following the procedure. Read more about this study
- Who is it for?
- Ages 75 years and older
- Conditions the study is for
- Digestive and Urological Surgery
- How many people
- 1,400 participants
- Where
- 1 siteFrance
- Study dates
- 31 May 2023to 28 Aug 2025
- 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 75 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Elderly patients scheduled to undergo one of the 4 procedures targeted by the study (colectomy, or cholecystectomy, or nephrectomy, or transurethral resection of prostate adenoma)
Who may be able to join
- Male or female subject, aged ≥ 75 years,
- Subject receiving or having received one of the 9 procedures targeted by the study: colectomy, or cholecystectomy, or nephrectomy, or transurethral resection of prostate adenoma, or transurethral prostatectomy, or transurethral or transcutaneous surgery for non-lithiasis conditions, or kidney and ureter surgery and major bladder surgery for tumor disease, or esophageal, stomach and duodenal surgery for malignancy, or transurethral resection of bladder,
- Subject orally agreeing (non-opposition), after having been informed and having been given a reasonable period of reflection, to participate in the study.
Who cannot join
- Patient having to undergo, at the time the study is proposed and over the theoretical period of participation, one or more other interventions already scheduled (other than the 9 mentioned in the inclusion criteria), and which, in the investigator's opinion, could have an impact on the study indicators7
- Subject unable to understand the purpose of the research, to answer questions and to give his/her decision to participate in the study,
- Subjects under legal protection or unable to express their consent, in accordance with article L1121-8 of the French Public Health Code,
- Subject already included in another research project involving the human body,
- Subject not affiliated to or not benefiting from a social security scheme.
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Geriatric Department, Broca Hospital
Paris, IIe-de-France, 75013
Olivier Hanon, MD PhD, +33 (0)1 44 08 35 03,, olivier.hanon@aphp.fr
About this study
The main objective of this study is to evaluate the effectiveness of experimental management by digestive or urological "new Peri-Operative Geriatric Units", on post-operative follow-up in the 3 months following the procedure.
Medical follow-up in the 10 days following the operation up to discharge, and patient outcomes in the 3 months following the operation, will be documented.
These data will be compared with data from subjects operated on in the reference year.
Read the detailed description
This is a multicenter, non-interventional, prospective retrospective study:
- Prospective group: inclusion of patients scheduled to undergo one of the 9 procedures targeted by the "new Peri-Operative Geriatric Units" trial (colectomy, cholecystectomy, , transurethral prostatectomy, transurethral or transcutaneous procedure for non-lithiasis conditions, kidney and ureter procedure and major bladder surgery for tumor condition esophageal, gastric and duodenal procedure for malignancy, transurethral bladder resection)
- Retrospective group: inclusion of patients who were operated in 2019
This study will assess whether "Peri-Operative Geriatric Units" for digestive or urinary surgery is beneficial for :
- Medical follow-up in the 10 days following the operation and up to discharge (simple follow-up, complications, return to the operating room, etc.),
- Patient outcomes in the 3 months following surgery (discharge date, geriatric assessment, rehospitalization, other significant medical events, etc.).
These data will be compared with those of patients operated on in the reference year prior to pandemic Covid-19 (2019), who unlike you will not have benefited from "new Peri-Operative Geriatric Units" care.
- Conditions
- Digestive and Urological Surgery
- Keywords
- Digestive and Urological Surgery, Peri-operative geriatric unit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prospective group | Patients who recieved geriatric perioperative car | |
| Retrospective group | Patients who received standard surgical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the effectiveness of experimental management by geriatric peri-operative digestive or urological units
Measured: 3 months
Secondary outcomes (5)
Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)
The Charlson Comorbidity Index (CCI) assesses the level of comorbidity by considering the level of severity of 19 predefined comorbid disorders and the number of disorders present among them.
Measured: At inclusion
Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL)
Katz Index of Independence in Activities of Daily Living is an unabbreviated scale title.
This Index ranks adequacy of performance in the six functions of bathing, dressing, toileting, transferring, continence, and feeding. Patients are scored yes/no for independence in each of the six functions. A score of 6 indicates full function, 4 indicates moderate impairment, and 2 or less indicates severe functional impairment.
Measured: 3 months
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Measured: 3 months
Screening for a nutritional disorder according Body Mass Index (BMI) score
Measured: 3 months
Assessment of a patient's pre-operative state of health according The American Society of Anaesthesiologists score (ASA)
To determine if patient is healthy enough to tolerate surgery and anesthesia
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2024
- Study start31 May 2023
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Digestive and Urological SurgeryStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 1,400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gérond'if
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Hanon, PhD, MPH, Study chair, Geriatric Departement, Broca Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06448494
- Sponsor's protocol ID
- 2022-A02302-41
- Acronym
- UPOG-DIGU
- Status last verified
- Jun 2024
- First submitted
- 4 Jun 2024
- Last updated
- 7 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the New Peri-Operative Geriatric Units in Ile-de-France, in Digestive and Urological Surgery
- ClinicalTrials.gov ID
- NCT06448494
- Acronym / sponsor ID
- UPOG-DIGU / 2022-A02302-41
- Conditions
- Digestive and Urological Surgery
- Keywords
- Digestive and Urological Surgery, Peri-operative geriatric unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,400 participants (estimated)
- Lead sponsor
- Gérond'ifUniversity, hospital or other
- Study start
- 31 May 2023 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Aug 2025 (estimated)
- First posted
- 7 Jun 2024 (actual)
- 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 main objective of this study is to evaluate the effectiveness of experimental management by digestive or urological "new Peri-Operative Geriatric Units", on post-operative follow-up in the 3 months following the procedure.
Medical follow-up in the 10 days following the operation up to discharge, and patient outcomes in the 3 months following the operation, will be documented.
These data will be compared with data from subjects operated on in the reference year.
Detailed description
This is a multicenter, non-interventional, prospective retrospective study:
- Prospective group: inclusion of patients scheduled to undergo one of the 9 procedures targeted by the "new Peri-Operative Geriatric Units" trial (colectomy, cholecystectomy, , transurethral prostatectomy, transurethral or transcutaneous procedure for non-lithiasis conditions, kidney and ureter procedure and major bladder surgery for tumor condition esophageal, gastric and duodenal procedure for malignancy, transurethral bladder resection)
- Retrospective group: inclusion of patients who were operated in 2019
This study will assess whether "Peri-Operative Geriatric Units" for digestive or urinary surgery is beneficial for :
- Medical follow-up in the 10 days following the operation and up to discharge (simple follow-up, complications, return to the operating room, etc.),
- Patient outcomes in the 3 months following surgery (discharge date, geriatric assessment, rehospitalization, other significant medical events, etc.).
These data will be compared with those of patients operated on in the reference year prior to pandemic Covid-19 (2019), who unlike you will not have benefited from "new Peri-Operative Geriatric Units" care.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective group | – | –Patients who recieved geriatric perioperative car |
| Retrospective group | – | –Patients who received standard surgical care |
Who may qualify
- Ages
- 75 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Elderly patients scheduled to undergo one of the 4 procedures targeted by the study (colectomy, or cholecystectomy, or nephrectomy, or transurethral resection of prostate adenoma)
Key inclusion criteria (3 listed)
- Male or female subject, aged ≥ 75 years,
- Subject receiving or having received one of the 9 procedures targeted by the study: colectomy, or cholecystectomy, or nephrectomy, or transurethral resection of prostate adenoma, or transurethral prostatectomy, or transurethral or transcutaneous surgery for non-lithiasis conditions, or kidney and ureter surgery and major bladder surgery for tumor disease, or esophageal, stomach and duodenal surgery for malignancy, or transurethral resection of bladder,
- Subject orally agreeing (non-opposition), after having been informed and having been given a reasonable period of reflection, to participate in the study.
Key exclusion criteria (5 listed)
- Patient having to undergo, at the time the study is proposed and over the theoretical period of participation, one or more other interventions already scheduled (other than the 9 mentioned in the inclusion criteria), and which, in the investigator's opinion, could have an impact on the study indicators7
- Subject unable to understand the purpose of the research, to answer questions and to give his/her decision to participate in the study,
- Subjects under legal protection or unable to express their consent, in accordance with article L1121-8 of the French Public Health Code,
- Subject already included in another research project involving the human body,
- Subject not affiliated to or not benefiting from a social security scheme.
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
Assessment of the effectiveness of experimental management by geriatric peri-operative digestive or urological units
Time frame: 3 months
5 secondary outcomes
Assessment of commorbidity risk according Charlson Comorbidity Index (CCI)
Time frame: At inclusion
Assessment of the degree of patient dependence according Katz Index of Independence in Activities of Daily Living (ADL)
Time frame: 3 months
Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale
Time frame: 3 months
Screening for a nutritional disorder according Body Mass Index (BMI) score
Time frame: 3 months
Assessment of a patient's pre-operative state of health according The American Society of Anaesthesiologists score (ASA)
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2024.
Related trials for Digestive and Urological Surgery
RecruitingObservational study
Product Surveillance Registry
Cardiac Rhythm Disorders, Urological Disorders
Not yet recruitingObservational study
Urinary and Sexual Symptoms in Patients With Hirschsprung Disease
Hirschsprung Disease
Not yet recruitingObservational study
Pelvic Floor Disorder Symptoms in Women Seeking Weight Loss Therapy
Lower Urinary Tract Symptoms, Stress Urinary Incontinence
Not yet recruiting
Comparison of Gastric Volume in I-gel and ProSeal Laryngeal Mask Airways
Nausea and Vomiting, Postoperative, Sore-throat
Active, not recruitingObservational study
Materiovigilance After Urinary Incontinence or Prolapse Surgery
Pelvic Organ Prolapse, Rectal Prolapse
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.
Olivier Hanon, PhD, MPH study chair
Geriatric Departement, Broca Hospital
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 Digestive and Urological Surgery, run by Gérond'if 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 5 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 7 Jun 2024. 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 Isabelle Dufour (+ 33 (0) 185781010, isabelle.dufour@gerondif.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the effectiveness of experimental management by geriatric peri-operative digestive or urological units (time frame: 3 months). 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 7 Jun 2024.