Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05272540 |
| Other study ID # |
BIA |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 13, 2016 |
| Est. completion date |
December 31, 2021 |
Study information
| Verified date |
March 2022 |
| Source |
University Hospital, Linkoeping |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Fluid is added during anesthesia and surgery to maintain and balance the dynamic hemodynamics
during a surgical procedure. Excess fluid after surgery is strongly correlated with morbidity
and mortality. Bioelectrical impedance analysis (BIA) measures the total body water.
Increased knowledge of the degree of preoperative hydration and the perioperative course can
contribute to active treatment and reduced morbidity.
Women and men ≥18 years of age who are to undergo gynecological or urological operations are
included in the study. The purpose is to analyze the baseline status of the degree of
hydration measured as the total body water and its components, and to monitor changes in
these during a postoperative course, and to look for connections between these parameters and
patient characteristics, laboratory data, type of surgery, type of anesthesia, care period
and onset of postoperative symptoms and complications.
Description:
Background Fluid is added during anesthesia and surgery to maintain and balance the dynamic
hemodynamics during a surgical procedure. The explanation for a positive fluid balance
correlating with an unfavorable postoperative course is believed to be an extracellular
volume expansion. Excess fluid after surgery is strongly correlated with morbidity and
mortality. Increased knowledge of the degree of preoperative hydration and the perioperative
course can contribute to active treatment and reduced morbidity.
Bioelectrical impedance analysis (BIA) measures the total body water expressed as a
percentage of fat-free body mass. In connection with surgery and a perioperative course,
there are few studies that have examined shifts in the body's fluid content with BIA.
The purpose of the study is to analyze the baseline status of the degree of hydration
measured as the total body water and its components, and to monitor changes in these during a
postoperative course, and to look for connections between these parameters and patient
characteristics, laboratory data, type of surgery, type of anesthesia, care period and onset
of postoperative symptoms and complications.
Overall hypothesis The degree of postoperative increase in the degree of hydration correlates
with postoperative symptoms and complications.
Secondary hypotheses
1. The accumulated sodium supply during the day of surgery correlates with the increase in
the proportion of extracellular body water postoperative day 1.
2. The development of lymphedema in patients undergoing surgery for suspected gynecological
malignancy with lymph node dissection can be detected in an early postoperative course.
3. Postoperative change in the degree of hydration correlates with the onset of
postoperative symptoms and/or complications.
4. Preoperatively low lean mass index increases the risk of postoperative complications
through a postoperative increase in extracellular body water.
5. Patients who are readmitted for complication after surgery have a persistently increased
proportion of extracellular body water.
6. In patients after day surgery in local anesthesia and sedation that are not given IV
fluid, no postoperative increase in the extracellular body water is seen.
7. In hysteroscopy and transurethral cystoscopy procedures, a change in extracellular body
water is seen.
8. Body mass index does not affect the precision of the measured body water composition.
Primary end-point Degree of hydration measured by bioelectrical impedance analysis
Secondary end-points
- Patients cared for as inpatient: Postoperative symptoms, duration of hospital care,
postoperative complications 8 weeks after surgery. Precision of bioimpedance analysis in
test-retest measurements.
- Patients operated on in day surgery: Postoperative symptoms, time to return home,
complications 8 weeks after surgery. Precision of bioimpedance analysis in test-retest
measurements.
Study design The study is a prospective descriptive study.
Patients Inclusion criteria
- Women and men ≥18 years of age who are to undergo gynecological or urological operations
under general anesthesia, regional anesthesia, sedation or local anesthesia
- Women and men who have given informed consent to participate in the study Exclusion
criteria
- Patients with pacemakers or implanted defibrillators (ICDs)
- Pregnant women with intrauterine viable pregnancy where the pregnancy should not be
terminated
- Disabled patients who can not stand on the scales
- Patients with one hand or foot missing
- Patients on dialysis due to kidney failure
- Patients who are unable to understand the meaning of the study and provide informed
consent
Methods All patients who undergo planned surgery at the department of gynecology and
department of urology at Linköping University Hospital for an 18-month period are screened
and those who meet inclusion criteria and lack exclusion criteria are asked to participate.
The degree of hydration will be measured with bioelectrical impedance analysis by weighing
the patient on the Tanita MC 780 scale systematically before and after the surgery or daily
during the care period. BIA data are measured in the morning with the patient fasting and
after the patient has urinated.
The study is divided into 2 parts:
Sub-study 1 - patients who are operated on as outpatients in day surgery; given local
anesthetics and sedation but no IV fluid.
Sub-study 2 - patients who are operated on as inpatients in hospital care; usually under
general anesthesia or under regional anesthesia and routinely receive IV fluid.
Sub-study 1 Patients who are operated in day surgery Treatment and care follow clinical
routine. Weighing before and after the surgery is added.
Preoperative data: Age, American Society of Anesthesiologists (ASA) class, co-morbidity, BIA
data, routine blood samples.
Peroperative data: Type of surgery, operation time, anesthesia time, type of anesthesia,
sedation (type/amount), peri-operative blockade, given fluid (type/volume).
Postoperative data at the hospital: Incidence of nausea and vomiting, time to go home, BIA
data and lab data (oxidative stress markers before going home; see under preoperative data)
and whether the patient has been admitted to the ward.
Postoperative data after discharge: Complications 8 weeks after surgery via medical record
review and the Gynop register or ward nurse who calls the patient and interviews.
Sub-study 2: Patients who are operated as inpatients Treatment and care follow clinical
routine. Preoperative data: Age, co-morbidity ASA class, BIA data, routine blood samples.
Clinical data: Type of surgery, operation time, anesthesia time, type of anesthesia,
peroperative bleeding, urine production, given fluid (type/volume).
Postoperative data in hospital: Incidence of nausea and vomiting, BIA data, daily routine
blood tests. Complications during care.
Postoperative data after discharge: Complications 8 weeks after surgery via medical
examination and the Gynop register or ward nurse who calls the patient and interviews.
BIA data To validate BIA data, the first 100 patients from each sub-study and department will
perform double measurements in immediate time sequence.
Lymfoedeoma Quality of Life (LYMQOL) questionnaire All participants fill in the questionnaire
about "swollen legs", LYMQOL, before surgery and after 4-6 weeks and 6 months
postoperatively.
Statistical considerations/power calculation No formal power calculation has been made
because the study is descriptive and hypothesis-generating /exploratory.
