Surgical Prehabilitation in Abdominal Surgery | NCT05057741

Studies
Surgical Prehabilitation in Abdominal Surgery

NCT05057741

Sponsor

Universidad del Rosario

Status

Completed

Last Update Posted

Jun 14, 2024Actual

Enrollment

24Actual

Phase

Not Applicable

Conditions

Older People
Prehabilitation
Surgical Procedure

Interventions

Multimodal prehabilitation

Countries

Colombia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
B- 17-2020	Other Grant/Funding Number	Centro de Investigaciones Mederi CIMED

Status Module

Record Verification Date

Jun 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 23, 2022Actual

Primary Completion Date

Jun 22, 2023Actual

Completion Date

Jun 23, 2023Actual

First Submitted Date

Sep 15, 2021

First Submission Date that Met QC Criteria

Sep 15, 2021

First Posted Date

Sep 27, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 12, 2024

Last Update Posted Date

Jun 14, 2024Actual

Name	Class
Hospital Universitario Mayor Mederi	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Randomized clinical trial evaluating changes in functional capacity, postoperative complications and 30-day mortality in patients over 60 years of age undergoing major gastrointestinal surgery who participate in a multimodal prehabilitation program, compared to non-prehabilitated patients.

Detailed Description

Introduction: A surgical procedure can have repercussions on the functionality and quality of life of patients, reducing their functional capacity by up to 40%; poor preoperative physical performance increases the risk of perioperative morbidity and mortality by 30% and prolongs functional recovery, increasing the hospital stay of the older adult. Prehabilitation is a preoperative intervention that improves the physical, psychological and nutritional condition of the patient to obtain a better postoperative recovery, mobility and functional independence.

Objective: To evaluate changes in functional capacity, postoperative complications and 30-day mortality in patients over 60 years of age undergoing major gastrointestinal surgery who participate in a multimodal prehabilitation program (exercise, nutrition and relaxation).

Methodology: Randomized clinical trial. Two study groups will be compared, an experimental group that will receive the educational intervention (multimodal prehabilitation program) and a control group that will continue with the usual management in the Hospital. The project activities will be carried out in Telehealth modality due to COVID-19 contagion containment measures.

Expected results: To encourage interprofessional work based on common goals with standardization of data and processes to improve physical condition and reduce post-surgical complications; to establish traceability of care, clinical and functional condition of the patient. It is intended to generate scientific evidence, integrate the research groups Méderi, Rehabilitation Sciences and Clinical Research.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Multimodal Prehabilitation	Experimental	Multimodal prehabilitation: exercise, nutrition and relaxation	Behavioral: Multimodal prehabilitation
Standard of Care	No Intervention	Usual care group: advice of surgeons about self care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Multimodal prehabilitation	Behavioral	Patients who will receive a multimodal prehabilitation program consisting of guided self-care activities at home that include exercise, nutrition and relaxation. Information Will be share by e health. Monitored by telephone daily during the first week and three times a week between the second and fourth week. The final evaluation of the program will be performed one working day after the control appointment with surgery, which will be scheduled ten days after hospital discharge; and the satisfaction survey will be applied. At 30 days after surgery, a telephone follow-up will be made to inquire about complications and mortality. On that day, self-care recommendations will be given.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
functional capacity	Changes in the maximum capacity to carry and use oxygen measured with the 2-minute stationary gait test (2MSG)	One to six weeks

Secondary Outcomes

Measure	Description	Time Frame
postoperative complications	Presence of morbidities, whether or not requiring hospital readmission, generated by the surgical procedure	30 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients scheduled by the General Surgery, Coloproctology and Hepatobiliary Surgery services
Cognitive ability to follow instructions,
Understand the material delivered (basic reading comprehension - through physical or digital media)
Perform physical exercise.
Aptitude to exercise according to the cardiovascular risk assessment performed by the treating physician.

Exclusion Criteria:

Patients scheduled for surgery from the emergency department
Patients with sepsis,
Patients with metastatic disease, without curative perspective
Patients with dysphagia for solid foods
Patients with incapacitating psychiatric or neurological illnesses
Patients with documented previous immunosuppression status (corticosteroid users in the 6 weeks prior to the randomisation) and/or HIV
Diabetic patients, with chronic renal disease, stage 4-5, with renal replacement therapy
Patients with heart failure decompensated, or that limits the physical exercise
Patients with dependent mobility
Patients with history of second primary neoplasm

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Hospital Universitario Mayor Mederi		Bogotá	Bogota D.C.		Colombia

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D009043	Motor Activity

ID	Term
D001519	Behavior

Intervention Model Description

A randomized clinical trial will be performed. Two study groups will be compared, an experimental group that will receive the educational intervention (multimodal prehabilitation program) and a control group that will continue with the usual management in the Hospital. The project activities will be carried out in Telehealth modality. When the patient accepts to participate in the study and signs the informed consent, he/she will be evaluated by nutrition and physiotherapy. After the initial evaluation that confirms the selection criteria, the patient will be randomly assigned to the study groups, by means of a computer based randomisation program.

The evaluators of the initial and final conditions of the patients will not know the group to which each patient entering the study has been assigned. The study will be conducted following good clinical practice. The estimated duration of recruitment is sixteen months.