Evaluation of the New Peri-Operative Geriatric Units in Ile-de-France, in Digestive and Urological Surgery

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age75+
SponsorGérond'if

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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,

Trial 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)

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

1,400 Participants
are grouped into 2 trial groups
Group A: Prospective group
Group B: Retrospective group

Trial outcomes

Primary outcomes

1

Assessment of the effectiveness of experimental management by geriatric peri-operative digestive or urological units

Time frame
3 months

Secondary outcomes

1

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.

Time frame
At inclusion
2

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.

Time frame
3 months
3

Assessment of patient's level of dependence through an appreciation of instrumental activities of daily living according Lawton scale

Time frame
3 months
4

Screening for a nutritional disorder according Body Mass Index (BMI) score

Time frame
3 months

Other outcomes

Sponsors and contacts

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