Trial Outcomes & Findings for Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece (NCT NCT04696276)
NCT ID: NCT04696276
Last Updated: 2025-03-26
Results Overview
Measuring how many days the participants will stay in hospital for the post-op recovery. It is defined as the time frame from the day of the surgery to the day of discharge from the hospital (unit: days).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
101 participants
Primary outcome timeframe
up to 30 postoperative days
Results posted on
2025-03-26
Participant Flow
Participants were recruited between January 2020 and December 2021 from a General Anticancer Oncology Centre of Athens, Greece.
After obtaining consent, participants were screened for for study inclusion criteria. If entry criteria were passed they were randomized to the study.
Participant milestones
| Measure |
A-ERAS
N=51 following the ERAS protocol
|
B-Non ERAS
N=50 following a conventional post-op care
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
50
|
|
Overall Study
COMPLETED
|
51
|
50
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
A-ERAS
n=51 Participants
following the ERAS protocol
|
B-Non ERAS
n=50 Participants
following a conventional post-op care
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=101 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
43 Participants
n=51 Participants
|
34 Participants
n=50 Participants
|
77 Participants
n=101 Participants
|
|
Age, Categorical
>=65 years
|
8 Participants
n=51 Participants
|
16 Participants
n=50 Participants
|
24 Participants
n=101 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=51 Participants
|
50 Participants
n=50 Participants
|
101 Participants
n=101 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=51 Participants
|
0 Participants
n=50 Participants
|
0 Participants
n=101 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Body Mass Index
|
26.4 kg/m^2
STANDARD_DEVIATION 0.7 • n=51 Participants
|
26.8 kg/m^2
STANDARD_DEVIATION 0.7 • n=50 Participants
|
26.6 kg/m^2
STANDARD_DEVIATION 0.7 • n=101 Participants
|
|
Marital status
unmarried
|
13 Participants
n=51 Participants
|
5 Participants
n=50 Participants
|
18 Participants
n=101 Participants
|
|
Marital status
married
|
23 Participants
n=51 Participants
|
32 Participants
n=50 Participants
|
55 Participants
n=101 Participants
|
|
Marital status
divorced
|
10 Participants
n=51 Participants
|
7 Participants
n=50 Participants
|
17 Participants
n=101 Participants
|
|
Marital status
widowed
|
5 Participants
n=51 Participants
|
6 Participants
n=50 Participants
|
11 Participants
n=101 Participants
|
|
Number of Children
No children
|
14 Participants
n=51 Participants
|
5 Participants
n=50 Participants
|
19 Participants
n=101 Participants
|
|
Number of Children
1 child
|
4 Participants
n=51 Participants
|
7 Participants
n=50 Participants
|
11 Participants
n=101 Participants
|
|
Number of Children
2 children
|
20 Participants
n=51 Participants
|
25 Participants
n=50 Participants
|
45 Participants
n=101 Participants
|
|
Number of Children
>2 children
|
13 Participants
n=51 Participants
|
13 Participants
n=50 Participants
|
26 Participants
n=101 Participants
|
|
educational level
primary school
|
7 Participants
n=51 Participants
|
7 Participants
n=50 Participants
|
14 Participants
n=101 Participants
|
|
educational level
high school
|
18 Participants
n=51 Participants
|
25 Participants
n=50 Participants
|
43 Participants
n=101 Participants
|
|
educational level
college / university
|
19 Participants
n=51 Participants
|
11 Participants
n=50 Participants
|
30 Participants
n=101 Participants
|
|
educational level
MSc / PhD
|
7 Participants
n=51 Participants
|
7 Participants
n=50 Participants
|
14 Participants
n=101 Participants
|
|
Profession
housewives / students
|
5 Participants
n=51 Participants
|
6 Participants
n=50 Participants
|
11 Participants
n=101 Participants
|
|
Profession
unemployed
|
4 Participants
n=51 Participants
|
8 Participants
n=50 Participants
|
12 Participants
n=101 Participants
|
|
Profession
workers
|
31 Participants
n=51 Participants
|
24 Participants
n=50 Participants
|
55 Participants
n=101 Participants
|
|
Profession
pensioners
|
11 Participants
n=51 Participants
|
12 Participants
n=50 Participants
|
23 Participants
n=101 Participants
|
|
Smoking
smokers
|
18 Participants
n=51 Participants
|
22 Participants
n=50 Participants
|
40 Participants
n=101 Participants
|
|
Smoking
non-smokers
|
33 Participants
n=51 Participants
|
28 Participants
n=50 Participants
|
61 Participants
n=101 Participants
|
|
alcohol consumption
0-1 drink per week
|
45 Participants
n=51 Participants
|
41 Participants
n=50 Participants
|
86 Participants
n=101 Participants
|
|
alcohol consumption
2+ drinks per week
|
6 Participants
n=51 Participants
|
9 Participants
n=50 Participants
|
15 Participants
n=101 Participants
|
|
endocrinological diseases
yes
|
20 Participants
n=51 Participants
|
21 Participants
n=50 Participants
|
41 Participants
n=101 Participants
|
|
endocrinological diseases
none
|
31 Participants
n=51 Participants
|
29 Participants
n=50 Participants
|
60 Participants
n=101 Participants
|
|
Urinary tract diseases
yes
|
0 Participants
n=51 Participants
|
2 Participants
n=50 Participants
|
2 Participants
n=101 Participants
|
|
Urinary tract diseases
none
|
51 Participants
n=51 Participants
|
48 Participants
n=50 Participants
|
99 Participants
n=101 Participants
|
|
kidney or liver disease
yes
|
3 Participants
n=51 Participants
|
6 Participants
n=50 Participants
|
9 Participants
n=101 Participants
|
|
kidney or liver disease
none
|
48 Participants
n=51 Participants
|
44 Participants
n=50 Participants
|
92 Participants
n=101 Participants
|
|
Cardiovascular diseases
yes
|
12 Participants
n=51 Participants
|
15 Participants
n=50 Participants
|
27 Participants
n=101 Participants
|
|
Cardiovascular diseases
none
|
39 Participants
n=51 Participants
|
35 Participants
n=50 Participants
|
74 Participants
n=101 Participants
|
|
Diseases of the respiratory system
yes
|
6 Participants
n=51 Participants
|
5 Participants
n=50 Participants
|
11 Participants
n=101 Participants
|
|
Diseases of the respiratory system
none
|
45 Participants
n=51 Participants
|
45 Participants
n=50 Participants
|
90 Participants
n=101 Participants
|
|
Diseases of the digestive system
yes
|
5 Participants
n=51 Participants
|
3 Participants
n=50 Participants
|
8 Participants
n=101 Participants
|
|
Diseases of the digestive system
none
|
46 Participants
n=51 Participants
|
47 Participants
n=50 Participants
|
93 Participants
n=101 Participants
|
|
nervous system diseases
yes
|
5 Participants
n=51 Participants
|
4 Participants
n=50 Participants
|
9 Participants
n=101 Participants
|
|
nervous system diseases
none
|
46 Participants
n=51 Participants
|
46 Participants
n=50 Participants
|
92 Participants
n=101 Participants
|
|
Skin diseases
yes
|
1 Participants
n=51 Participants
|
1 Participants
n=50 Participants
|
2 Participants
n=101 Participants
|
|
Skin diseases
no
|
50 Participants
n=51 Participants
|
49 Participants
n=50 Participants
|
99 Participants
n=101 Participants
|
|
other malignancy
had other cancer in the past
|
13 Participants
n=51 Participants
|
6 Participants
n=50 Participants
|
19 Participants
n=101 Participants
|
|
other malignancy
had not cancer in the past
|
38 Participants
n=51 Participants
|
44 Participants
n=50 Participants
|
82 Participants
n=101 Participants
|
|
Allergies
yes
|
12 Participants
n=51 Participants
|
9 Participants
n=50 Participants
|
21 Participants
n=101 Participants
|
|
Allergies
no
|
39 Participants
n=51 Participants
|
41 Participants
n=50 Participants
|
80 Participants
n=101 Participants
|
|
Hemoglobin
|
12.7 g/dl
STANDARD_DEVIATION 1.1 • n=51 Participants
|
12.6 g/dl
STANDARD_DEVIATION 1.5 • n=50 Participants
|
12.65 g/dl
STANDARD_DEVIATION 1.3 • n=101 Participants
|
|
Hematocrit
|
38.9 percentage % of red blood cells in blood
STANDARD_DEVIATION 3.2 • n=51 Participants
|
38.7 percentage % of red blood cells in blood
STANDARD_DEVIATION 4.5 • n=50 Participants
|
38.8 percentage % of red blood cells in blood
STANDARD_DEVIATION 3.85 • n=101 Participants
|
|
WBC
|
6.9 g/dl
STANDARD_DEVIATION 2 • n=51 Participants
|
7.6 g/dl
STANDARD_DEVIATION 2.1 • n=50 Participants
|
7.25 g/dl
STANDARD_DEVIATION 2.05 • n=101 Participants
|
|
Glucose
|
96.7 mg/dl
STANDARD_DEVIATION 20.9 • n=51 Participants
|
101 mg/dl
STANDARD_DEVIATION 21.2 • n=50 Participants
|
98.85 mg/dl
STANDARD_DEVIATION 21.05 • n=101 Participants
|
|
Plasma proteins
|
7.1 g/dl
STANDARD_DEVIATION 0.6 • n=51 Participants
|
7.2 g/dl
STANDARD_DEVIATION 0.6 • n=50 Participants
|
7.15 g/dl
STANDARD_DEVIATION 0.6 • n=101 Participants
|
|
Albumin
|
4.2 g/dl
STANDARD_DEVIATION 0.4 • n=51 Participants
|
4.3 g/dl
STANDARD_DEVIATION 0.5 • n=50 Participants
|
4.25 g/dl
STANDARD_DEVIATION 0.45 • n=101 Participants
|
PRIMARY outcome
Timeframe: up to 30 postoperative daysMeasuring how many days the participants will stay in hospital for the post-op recovery. It is defined as the time frame from the day of the surgery to the day of discharge from the hospital (unit: days).
Outcome measures
| Measure |
LOS in ERAS Group
n=51 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=50 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Length of Hospital Stay (LOS)
|
3.8 days
Interval 2.0 to 10.0
|
5.9 days
Interval 3.0 to 10.0
|
PRIMARY outcome
Timeframe: up to 3 postoperative daysEvaluation of analgesia and correlation of requirements with opioid analgesics; by recording of postoperative pain levels and the evaluation of the effectiveness of analgesic treatment of patients. Using Numbered pain Scale, from 0 that means no pain at all, to 10 that means the worst pain. As lower the number on pain scale as better the outcome.
Outcome measures
| Measure |
LOS in ERAS Group
n=51 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=50 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Pain Levels
|
3.6 units on a scale
Standard Deviation 1
|
4.6 units on a scale
Standard Deviation 1.2
|
PRIMARY outcome
Timeframe: within the first 18 postoperative hoursThe number of participants who had the ability to have a sit steadily on a chair himself, within the first 18 hours after the surgery.
Outcome measures
| Measure |
LOS in ERAS Group
n=49 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=49 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Number of Participants With the Ability to Getting up in a Chair Within 18h
|
46 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: within the first 18 hours after the surgeryThe participants should be able to stand on their feet, walk in the room, go to the toilet and make a short walk in the surgical ward within the first 18 hours after the surgery. Mobilization time, which is defined as the time frame from the end of the operation until they are able to walk without external assistance (unit: hours).
Outcome measures
| Measure |
LOS in ERAS Group
n=50 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=49 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively
|
48 Participants
|
9 Participants
|
PRIMARY outcome
Timeframe: up to 6 hours postoperativelyFeeding within the first 6 hours after the surgery. The participants should be able to drink clear fluids (water, tea,chamomile, apple juice, filter coffee, jelo) with or without sweeteners, given that they don't have PONV.
Outcome measures
| Measure |
LOS in ERAS Group
n=50 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=49 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Early Feeding
|
44 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: within 24 hours post surgeryNumber of participants who had their digestive system function on time, with hunger, bowel sounds and bowel movements within the first 24 hours postoperatively
Outcome measures
| Measure |
LOS in ERAS Group
n=50 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=49 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Early Mobilization of the Digestive System
|
46 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: within 24 h post surgeryNumber of participants who had early discontinuation of IV fluids and conversion to per os within 24 hours postoperatively
Outcome measures
| Measure |
LOS in ERAS Group
n=50 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=49 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Early Discontinuation of IV Administration
|
41 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: within the first 24h after surgeryNumber of participants who had their urinary catheter removed within 24 hours postoperatively
Outcome measures
| Measure |
LOS in ERAS Group
n=45 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=44 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Number of Participants Who Had Their Urinary Catheter Removal
|
43 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: within 24h post surgeryNumber of Participants who had their drainage removal within 24 hours postoperatively
Outcome measures
| Measure |
LOS in ERAS Group
n=50 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=49 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Number of Participants Who Had Their Drainage Removal Within 24h
|
48 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: within 48 hours post surgeryNumber of participants who had blood transfusion during their intraoperative and postoperative time
Outcome measures
| Measure |
LOS in ERAS Group
n=51 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=50 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Blood Transfusion
|
0 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: up to 5 postoperative daysThe evaluation of postoperative complications such as bleeding, thrombosis and inflammation.
Outcome measures
| Measure |
LOS in ERAS Group
n=50 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=49 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Postoperative Complications
postoperative bilirubin
|
11 participants
|
16 participants
|
|
Postoperative Complications
nausea
|
16 participants
|
22 participants
|
|
Postoperative Complications
vomiting
|
9 participants
|
18 participants
|
|
Postoperative Complications
somnolence
|
4 participants
|
17 participants
|
|
Postoperative Complications
repression
|
2 participants
|
10 participants
|
|
Postoperative Complications
bleeding
|
1 participants
|
5 participants
|
|
Postoperative Complications
fever
|
1 participants
|
11 participants
|
|
Postoperative Complications
urinary tract infection
|
0 participants
|
4 participants
|
|
Postoperative Complications
re-operation
|
1 participants
|
2 participants
|
SECONDARY outcome
Timeframe: up to 30 postoperative daysReadmission rate by 30 days after discharge from the hospital
Outcome measures
| Measure |
LOS in ERAS Group
n=51 Participants
Participants in ERAS group had received the enhanced recovery after surgery care
|
LOS in Non-ERAS Group
n=50 Participants
Participants in the non-ERAS group had received the convectional care after surgery
|
|---|---|---|
|
Readmission
|
0 participants
|
1 participants
|
Adverse Events
Number of Adverse Events in ERAS Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Number of Adverse Events in Non-ERAS Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place