Evaluation of Multidisciplinary Recovery After Surgery Program in Orthopedics and Traumatology

NCT ID: NCT03822247

Last Updated: 2019-02-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-01-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The aim of the recovery protocol is to reduce surgical trauma, postoperative pain, and complications, shorten hospital treatment and improve postoperative recovery. Orthopedic and traumatology surgeries are often followed by a long-lasting recovery with difficulties of everyday functioning. Up to this time, only a few publications of multidisciplinary protocol in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of multidisciplinary after surgery recovery program in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It focuses on patient education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The implementation of the program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The protocol combines scientifically proven interventions to standardize medical care, improve treatment outcomes and reduce healthcare costs. The aim is to reduce surgical trauma and postoperative pain, reduce complications, shorten hospital treatment and improve postoperative recovery. Moreover, it has been shown that using standardized, patient oriented recovery protocol significantly improves the outcomes and quality of care, but also brings financial benefit for the hospital as well as for the health system in general. Studies about implementing multidisciplinary recovery protocol in orthopedic and traumatology are scarce. Orthopedic and traumatology surgeries are often followed by a long-lasting and demanding recovery characterized by the difficulties of everyday functioning. Recovery is therefore multidisciplinary: for example, it is necessary to monitor the nutritional status of a patient, decrease postoperative pain, monitor cognitive status, etc. Until now only a few publications of recovery protocols in orthopedics and traumatology have been published, mostly to improve the care of patients after elective surgical procedures. The goal of this protocol in orthopedics and traumatology is to improve the care of both urgent and elective patients using standardized, multi-professional care programs. It was created based on evidence-based practice and modified by multidisciplinary team of orthopedic and traumatology surgeons, anesthesiologists, physiatrist, physiotherapists, specialized medical nurses, nutritionists, and psychiatrists. It focuses on patient preoperative education, preoperative respiratory training, adequate nutritive and hemodynamic support, modified local and regional anesthesia protocol, prevention of postoperative pain, nausea and vomiting, and early postoperative delirium detection. The investigators postulate that the implementation of this program will reduce the rate of postoperative complications and the rate of rehospitalization, enhance the recovery after surgery and increase the satisfaction with the treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hip Fractures Knee Fracture Hip Arthritis Knee Arthritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Multidisciplinary Recovery Program

Two cohorts of patients will randomly be placed in either experimental od no intervention group.

Patients undergoing Multidisciplinary Recovery After Surgery Program will gain better preparation for early mobilization after surgery, nutritional support, individually modified analgesia and psychological support during inpatient treatment. Program includes preoperative, intraoperative and postoperative multidisciplinary comprehensive interventions.

Group Type EXPERIMENTAL

Multidisciplinary Recovery Program

Intervention Type PROCEDURE

Preoperative care:

* Patient's education
* Providing respiratory training
* Assessment of nutritional status
* Application of compression stockings
* Thromboembolism prophylaxis by low molecular weighted heparin
* Induction of hemodynamic support 12 hours before the surgery
* Oral carbohydrate solution loading until 2 hours before the surgery

Intraoperative care:

* Maintaining normothermia
* Multimodal prevention of postoperative nausea and vomiting
* Use of spinal anesthesia
* Prevention of excessive blood loss
* Local anesthetic infiltration

Postoperative care:

* Active pain control
* Early mobilization
* Early onset of oral nutrition
* Early delirium detection
* Application of compression stockings

Conventional Perioperative Care

Patients undergoing conventional care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Multidisciplinary Recovery Program

Preoperative care:

* Patient's education
* Providing respiratory training
* Assessment of nutritional status
* Application of compression stockings
* Thromboembolism prophylaxis by low molecular weighted heparin
* Induction of hemodynamic support 12 hours before the surgery
* Oral carbohydrate solution loading until 2 hours before the surgery

Intraoperative care:

* Maintaining normothermia
* Multimodal prevention of postoperative nausea and vomiting
* Use of spinal anesthesia
* Prevention of excessive blood loss
* Local anesthetic infiltration

Postoperative care:

* Active pain control
* Early mobilization
* Early onset of oral nutrition
* Early delirium detection
* Application of compression stockings

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Fracture od proximal femur or knee fracture requiring surgery
* Hip or knee arthrosis requiring joint replacement
* American Society of Anesthesiologists (ASA) score II or III
* Ability to provide informed consent

Exclusion Criteria

* Severe cognitive impairment
* Pregnancy
* End stage of malignant disease
* Decompensated heart or liver disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Klinički Bolnički Centar Zagreb

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nikica Darabos

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nikica Daraboš

Role: STUDY_CHAIR

Head of Department of traumatology, bone and joint surgery

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

KBC Zagreb

Zagreb, , Croatia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Croatia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nikica Daraboš

Role: CONTACT

+385 1 2388 203

Sara Medved

Role: CONTACT

+385 1 2388 394

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nikica Daraboš

Role: primary

+385 1 2388 203

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

KBC Zagreb Surgery

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.