Postoperative ComplicationsNCT05272540
Changes in Body Water During Surgery
An observational study of Postoperative Complications and Bioelectrical Impedance, run by University Hospital, Linkoeping.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Complications, Bioelectrical Impedance, Hospital Stay
- How many people
- 1,696 participants
- Where
- No sites listed yet
- Study dates
- 13 Sep 2016to 31 Dec 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Women and men ≥18 years of age who are to undergo planned gynecological or urological operations under general anesthesia, regional anesthesia, sedation or local anesthesia at the University Hospital, Linköping, Sweden.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: Relationship Between Degree of Hydration Measured With Bioelectrical Impedance Phase Angle Analysis, Oxidative Stress and Postoperative Complications, a Prospective Study.
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.
Read the detailed 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
- The accumulated sodium supply during the day of surgery correlates with the increase in the proportion of extracellular body water postoperative day 1.
- The development of lymphedema in patients undergoing surgery for suspected gynecological malignancy with lymph node dissection can be detected in an early postoperative course.
- Postoperative change in the degree of hydration correlates with the onset of postoperative symptoms and/or complications.
- Preoperatively low lean mass index increases the risk of postoperative complications through a postoperative increase in extracellular body water.
- Patients who are readmitted for complication after surgery have a persistently increased proportion of extracellular body water.
- 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.
- In hysteroscopy and transurethral cystoscopy procedures, a change in extracellular body water is seen.
- 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.
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Day case surgery | Adult patients who are operated on as outpatients in day surgery. Treatment and care follow clinical routine. Weighing on a scales measuring bioelectrical impedance data before and after the surgery is added. | |
| In patient surgery | Adult patients who are operated on as inpatients in hospital care. Treatment and care follow clinical routine. Weighing on a scales measuring bioelectrical impedance data before the surgery and every morning during hospital stay is added. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative change in hydration
Degree of hydration measured by bioelectrical impedance analysis
Measured: Preoperative on day of surgery and postoperative daily during hospital stay up to 30 days after surgery
Secondary outcomes (7)
Postoperative symptoms
Nausea, vomiting
Measured: Day of surgery until 8 week postoperatively
Postoperative complications
According to a prespecified list of complications
Measured: Day of surgery until 8 week postoperatively
Duration of hospital care
Time spent in hospital in connection with surgery either as outpatient or inpatient care
Measured: Day of surgery until 8 weeks postoperatively
Precision of bioimpedance analysis of total body water in test-retest measurements.
Total body water
Measured: Two repeated measurements preoperatively (less than 10 minutes)
Precision of bioimpedance analysis of intracellular water in test-retest measurements.
Intracellular water, percent of total body water
Measured: Two repeated measurements preoperatively (less than 10 minutes)
Precision of bioimpedance analysis of extracellular water in test-retest measurements.
Extracellular water, percent of total body water
Measured: Two repeated measurements preoperatively (less than 10 minutes)
Precision of bioimpedance analysis of phase angel in test-retest measurements.
Phase angel, 0-90 degrees
Measured: Two repeated measurements preoperatively (less than 10 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start13 Sep 2016
- Primary completion19 Aug 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,696 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Linkoeping
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Preben Kjolhede, MD, professor, University Hospital, Linkoeping
- Investigators
- Preben Kjölhede, Prof., Study chair, University Hospital, Linköing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05272540
- Sponsor's protocol ID
- BIA
- Status last verified
- Mar 2022
- First submitted
- 15 Feb 2022
- Last updated
- 9 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Asklof M, Kjolhede P, Wodlin NB, Nilsson L. Bioelectrical impedance analysis; a new method to evaluate lymphoedema, fluid status, and tissue damage after gynaecological surgery - A systematic review. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:111-119. doi: 10.1016/j.ejogrb.2018.06.024. Epub 2018 Jun 18.
PubMed 29933195
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relationship Between Degree of Hydration Measured With Bioelectrical Impedance Phase Angle Analysis, Oxidative Stress and Postoperative Complications, a Prospective Study.
- ClinicalTrials.gov ID
- NCT05272540
- Acronym / sponsor ID
- BIA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,696 participants (actual)
- Lead sponsor
- University Hospital, LinkoepingUniversity, hospital or other
- Study start
- 13 Sep 2016 (actual)
- Primary completion
- 19 Aug 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 9 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
- The accumulated sodium supply during the day of surgery correlates with the increase in the proportion of extracellular body water postoperative day 1.
- The development of lymphedema in patients undergoing surgery for suspected gynecological malignancy with lymph node dissection can be detected in an early postoperative course.
- Postoperative change in the degree of hydration correlates with the onset of postoperative symptoms and/or complications.
- Preoperatively low lean mass index increases the risk of postoperative complications through a postoperative increase in extracellular body water.
- Patients who are readmitted for complication after surgery have a persistently increased proportion of extracellular body water.
- 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.
- In hysteroscopy and transurethral cystoscopy procedures, a change in extracellular body water is seen.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Day case surgery | – | –Adult patients who are operated on as outpatients in day surgery. Treatment and care follow clinical routine. Weighing on a scales measuring bioelectrical impedance data before and after the surgery is added. |
| In patient surgery | – | –Adult patients who are operated on as inpatients in hospital care. Treatment and care follow clinical routine. Weighing on a scales measuring bioelectrical impedance data before the surgery and every morning during hospital stay is added. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women and men ≥18 years of age who are to undergo planned gynecological or urological operations under general anesthesia, regional anesthesia, sedation or local anesthesia at the University Hospital, Linköping, Sweden.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Perioperative change in hydration
Time frame: Preoperative on day of surgery and postoperative daily during hospital stay up to 30 days after surgery
Degree of hydration measured by bioelectrical impedance analysis
7 secondary outcomes
Postoperative symptoms
Time frame: Day of surgery until 8 week postoperatively
Postoperative complications
Time frame: Day of surgery until 8 week postoperatively
Duration of hospital care
Time frame: Day of surgery until 8 weeks postoperatively
Precision of bioimpedance analysis of total body water in test-retest measurements.
Time frame: Two repeated measurements preoperatively (less than 10 minutes)
Precision of bioimpedance analysis of intracellular water in test-retest measurements.
Time frame: Two repeated measurements preoperatively (less than 10 minutes)
Precision of bioimpedance analysis of extracellular water in test-retest measurements.
Time frame: Two repeated measurements preoperatively (less than 10 minutes)
Precision of bioimpedance analysis of phase angel in test-retest measurements.
Time frame: Two repeated measurements preoperatively (less than 10 minutes)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Background: PubMed 29933195Asklof M, Kjolhede P, Wodlin NB, Nilsson L. Bioelectrical impedance analysis; a new method to evaluate lymphoedema, fluid status, and tissue damage after gynaecological surgery - A systematic review. Eur J Obstet Gynecol Reprod Biol. 2018 Sep;228:111-119. doi: 10.1016/j.ejogrb.2018.06.024. Epub 2018 Jun 18.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Preben Kjölhede, Prof. study chair
University Hospital, Linköing
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Complications and Bioelectrical Impedance, run by University Hospital, Linkoeping.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative change in hydration (time frame: Preoperative on day of surgery and postoperative daily during hospital stay up to 30 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05272540, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.