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Clinical Trials/NCT06176274
NCT06176274
Not Yet Recruiting
N/A

The Effect of Pre-Operative Prehabilitation Program on Postoperative Recovery in Women With Gynecological Cancer

Istanbul University - Cerrahpasa (IUC)1 site in 1 country50 target enrollmentJanuary 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Gynecologic Cancer
Sponsor
Istanbul University - Cerrahpasa (IUC)
Enrollment
50
Locations
1
Primary Endpoint
the WHODASS proficiency scale
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

The aim of this study is to determine the effect of the prehabilitation program applied to postmenopausal women diagnosed with gynecological cancer before surgery on postoperative recovery, planned as a randomized study with an experimental design with a pre-test post-test control group.

Detailed Description

The aim of prehabilitation programs is to eliminate intraoperative complications by increasing the functional capacity and metabolic reserves of patients before surgical treatment and to accelerate recovery in the postoperative period. In addition, it helps the patient to maximize the existing capacity of the patient before the surgery, to know what will happen at each stage of the treatment to be applied to the patient, to feel better physically and spiritually and to understand the roles and responsibilities of the individual care of the patient, as well as making a significant contribution to the positive results of the operation. It is to provide exercise, psychological support, nutritional counseling and optimization of the underlying conditions by stopping negative health behaviors. There are non-eliminable criteria such as age, gender, comorbid diseases before surgery, as well as modifiable factors such as the regulation of the patients nutrition, ensuring psychological well-being, quitting smoking. In particular, some factors directly affect the state of well-being during the perioperative period. Thus, surgeries become safer.As a practice, the prehabilitation program (according to the surgery program) is planned in the preoperative period between 2-4 weeks Dec. Participants who do not comply with the program will be excluded from the sample

Registry
clinicaltrials.gov
Start Date
January 1, 2024
End Date
November 30, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Istanbul University - Cerrahpasa (IUC)
Responsible Party
Principal Investigator
Principal Investigator

Hilal Evgin

Principal Investigator

Istanbul University - Cerrahpasa (IUC)

Eligibility Criteria

Inclusion Criteria

  • Patients who are not stage 4 in preoperative evaluation
  • Who volunteered to participate in the study
  • 6 months have passed since the last treatment (Chemoretapy, Radiotherapy)
  • Women who do not have Turkish literacy problems
  • Women aged 50 and older who are in the postmenopausal period
  • Patients who are scheduled for abdominal surgery

Exclusion Criteria

  • High-risk comorbid diseases such as COPD, heart failure
  • Physical and mental conditions that will interfere with nutrition and exercise
  • Those with orthopedic and neuromuscular diseases
  • Those who are scheduled for surgery by laparoscopic/laparotomic method
  • Those who cannot adapt to the program during the preoperative period
  • Women who are too depressed during preoperative evaluation

Outcomes

Primary Outcomes

the WHODASS proficiency scale

Time Frame: 1 weeks

the WHODASS proficiency scale will be used. It is useful for a brief assessment of the overall functionality.

the Quality of Recovery QoR-15

Time Frame: 6 weeks

The scale is based on the assumption that the higher the score, the better the quality of improvement when measuring between 0 and 150 points. The scale is based on the assumption that the higher the score, the better the quality of Deceleration.

functional capacity 6MWT

Time Frame: 10 weeks

6MWT has also been used to determine the functional status of patients . During the test, a standardized protocol is followed by walking on a flat floor for 6 minutes. It is a self-paced test and is a repeatable, cheap and easy test (unlike the increasingly brisk walking tests that require intervention).

day of hospital stay

Time Frame: 1 weeks

the length of hospital stay

Study Sites (1)

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