Endometrial Cancer, Gynecologic Cancer, Hysterectomy, Ovarian Cancer
Conditions
Keywords
gynecologic cancer, ERAS protocols, ERAS pathways, Gynecologic/oncology surgery
Brief summary
The Enhanced Recovery After Surgery (ERAS) program includes preoperative counseling, fasting avoidance, non-opioid analgesia, fluid balance, normothermia and early mobilization. ERAS pathways were developed to reduce hospital length of stay, reduce costs and decrease perioperative opioid requirements, and be beneficial for patients. We propose the hypothesis that the ERAS pathway could reduce the length of stay (LOS) in hospital for patients undergoing major gynecologic oncology surgery (MGOS). Patients were randomly allocated in two groups: An ERAS pathway group including preoperative counseling, early feeding/mobilization, and opioid-sparing multimodal analgesia; and a classic model group of post operative recovery as control.
Detailed description
The Gynecological Cancer of the inner genital organs includes ovarian cancer, endometrial and cervical cancer and its therapeutic approach is surgical removal of the organ with cancer. The last decade has developed various postoperative recovery protocols aimed at safe and rapid recovery of the patient after a surgery and early discharge from the hospital. These protocols are known as ERAS (Enhanced Recovery After Surgery) protocols or Fast-Track (FT) and combine various evidence-based perioperative care techniques. The ERAS protocols include specific approaches preoperative, intraoperative and postoperative, by the multidisciplinary team (surgeon, anesthetist and nurse), and aim at reducing the postoperative stress and pain, fasten the feeding and the mobilization of the patient after the surgery and rapid the hospital discharge. This trial is designed to evaluate the superiority of the ERAS pathway to conventional non-ERAS clinical practice in reducing the LOS. The results may provide new insight into the clinical applications of the ERAS pathway for MGOS. This doctoral thesis aims to compare the effectiveness of the Protocol ERAS against the classical model of recovery, in the postoperative recovery of patients with Gynecological Cancer undergoing MGOS, in a Public Oncology Hospital in Greece. The importance of ERAS programs is expected to emerge in the length of hospital stay, in pain control, in perioperative stress, in the early feeding and mobilization of patients who have undergone MGOS.
Interventions
OTHERERAS protocol
special approaches in three phases preoperatively, intraoperatively and postoperatively, by an interdisciplinary team comprising of the surgeon, the anesthesiologist and the nurse. The combination of these techniques reduces the reaction to postoperative stress, relieves acute postoperative pain, restores the patient immediately to their original feeding and mobilization habits, thus reducing the time required for their complete recovery.
Sponsors
University of West Attica
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 79 Years
Healthy volunteers
No
Inclusion criteria
* Greek language speakers * Have complete mental clarity * Age \>18 years
Exclusion criteria
* Refusal to sign consent * Patients receiving treatment for chronic pain * Patients receiving antipsychotic therapy, Psychopathy * They have acute or chronic kidney and / or liver disease * History or family history of malignant hyperthermia * Known allergy to propofol, desflurane, or any other anesthetic agent * Impairment of cognitive function or communication * History of postoperative delirium
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospital Stay (LOS) | up to 30 postoperative days | 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). |
| Pain Levels | up to 3 postoperative days | Evaluation 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. |
| Number of Participants With the Ability to Getting up in a Chair Within 18h | within the first 18 postoperative hours | The number of participants who had the ability to have a sit steadily on a chair himself, within the first 18 hours after the surgery. |
| Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively | within the first 18 hours after the surgery | The 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). |
| Early Feeding | up to 6 hours postoperatively | Feeding 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Complications | up to 5 postoperative days | The evaluation of postoperative complications such as bleeding, thrombosis and inflammation. |
| Early Mobilization of the Digestive System | within 24 hours post surgery | Number of participants who had their digestive system function on time, with hunger, bowel sounds and bowel movements within the first 24 hours postoperatively |
| Readmission | up to 30 postoperative days | Readmission rate by 30 days after discharge from the hospital |
| Early Discontinuation of IV Administration | within 24 h post surgery | Number of participants who had early discontinuation of IV fluids and conversion to per os within 24 hours postoperatively |
| Number of Participants Who Had Their Urinary Catheter Removal | within the first 24h after surgery | Number of participants who had their urinary catheter removed within 24 hours postoperatively |
| Number of Participants Who Had Their Drainage Removal Within 24h | within 24h post surgery | Number of Participants who had their drainage removal within 24 hours postoperatively |
| Blood Transfusion | within 48 hours post surgery | Number of participants who had blood transfusion during their intraoperative and postoperative time |
Countries
Greece
Participant flow
Recruitment details
Participants were recruited between January 2020 and December 2021 from a General Anticancer Oncology Centre of Athens, Greece.
Pre-assignment details
After obtaining consent, participants were screened for for study inclusion criteria. If entry criteria were passed they were randomized to the study.
Participants by arm
| Arm | Count |
|---|---|
| A-ERAS following the ERAS protocol | 51 |
| B-Non ERAS following a conventional post-op care | 50 |
| Total | 101 |
Baseline characteristics
| Characteristic | A-ERAS | B-Non ERAS | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 8 Participants | 16 Participants | 24 Participants |
| Age, Categorical Between 18 and 65 years | 43 Participants | 34 Participants | 77 Participants |
| Albumin | 4.2 g/dl STANDARD_DEVIATION 0.4 | 4.3 g/dl STANDARD_DEVIATION 0.5 | 4.25 g/dl STANDARD_DEVIATION 0.45 |
| alcohol consumption 0-1 drink per week | 45 Participants | 41 Participants | 86 Participants |
| alcohol consumption 2+ drinks per week | 6 Participants | 9 Participants | 15 Participants |
| Allergies no | 39 Participants | 41 Participants | 80 Participants |
| Allergies yes | 12 Participants | 9 Participants | 21 Participants |
| Body Mass Index | 26.4 kg/m^2 STANDARD_DEVIATION 0.7 | 26.8 kg/m^2 STANDARD_DEVIATION 0.7 | 26.6 kg/m^2 STANDARD_DEVIATION 0.7 |
| Cardiovascular diseases none | 39 Participants | 35 Participants | 74 Participants |
| Cardiovascular diseases yes | 12 Participants | 15 Participants | 27 Participants |
| Diseases of the digestive system none | 46 Participants | 47 Participants | 93 Participants |
| Diseases of the digestive system yes | 5 Participants | 3 Participants | 8 Participants |
| Diseases of the respiratory system none | 45 Participants | 45 Participants | 90 Participants |
| Diseases of the respiratory system yes | 6 Participants | 5 Participants | 11 Participants |
| educational level college / university | 19 Participants | 11 Participants | 30 Participants |
| educational level high school | 18 Participants | 25 Participants | 43 Participants |
| educational level MSc / PhD | 7 Participants | 7 Participants | 14 Participants |
| educational level primary school | 7 Participants | 7 Participants | 14 Participants |
| endocrinological diseases none | 31 Participants | 29 Participants | 60 Participants |
| endocrinological diseases yes | 20 Participants | 21 Participants | 41 Participants |
| Glucose | 96.7 mg/dl STANDARD_DEVIATION 20.9 | 101 mg/dl STANDARD_DEVIATION 21.2 | 98.85 mg/dl STANDARD_DEVIATION 21.05 |
| Hematocrit | 38.9 percentage % of red blood cells in blood STANDARD_DEVIATION 3.2 | 38.7 percentage % of red blood cells in blood STANDARD_DEVIATION 4.5 | 38.8 percentage % of red blood cells in blood STANDARD_DEVIATION 3.85 |
| Hemoglobin | 12.7 g/dl STANDARD_DEVIATION 1.1 | 12.6 g/dl STANDARD_DEVIATION 1.5 | 12.65 g/dl STANDARD_DEVIATION 1.3 |
| kidney or liver disease none | 48 Participants | 44 Participants | 92 Participants |
| kidney or liver disease yes | 3 Participants | 6 Participants | 9 Participants |
| Marital status divorced | 10 Participants | 7 Participants | 17 Participants |
| Marital status married | 23 Participants | 32 Participants | 55 Participants |
| Marital status unmarried | 13 Participants | 5 Participants | 18 Participants |
| Marital status widowed | 5 Participants | 6 Participants | 11 Participants |
| nervous system diseases none | 46 Participants | 46 Participants | 92 Participants |
| nervous system diseases yes | 5 Participants | 4 Participants | 9 Participants |
| Number of Children 1 child | 4 Participants | 7 Participants | 11 Participants |
| Number of Children >2 children | 13 Participants | 13 Participants | 26 Participants |
| Number of Children 2 children | 20 Participants | 25 Participants | 45 Participants |
| Number of Children No children | 14 Participants | 5 Participants | 19 Participants |
| other malignancy had not cancer in the past | 38 Participants | 44 Participants | 82 Participants |
| other malignancy had other cancer in the past | 13 Participants | 6 Participants | 19 Participants |
| Plasma proteins | 7.1 g/dl STANDARD_DEVIATION 0.6 | 7.2 g/dl STANDARD_DEVIATION 0.6 | 7.15 g/dl STANDARD_DEVIATION 0.6 |
| Profession housewives / students | 5 Participants | 6 Participants | 11 Participants |
| Profession pensioners | 11 Participants | 12 Participants | 23 Participants |
| Profession unemployed | 4 Participants | 8 Participants | 12 Participants |
| Profession workers | 31 Participants | 24 Participants | 55 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 51 Participants | 50 Participants | 101 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Skin diseases no | 50 Participants | 49 Participants | 99 Participants |
| Skin diseases yes | 1 Participants | 1 Participants | 2 Participants |
| Smoking non-smokers | 33 Participants | 28 Participants | 61 Participants |
| Smoking smokers | 18 Participants | 22 Participants | 40 Participants |
| Urinary tract diseases none | 51 Participants | 48 Participants | 99 Participants |
| Urinary tract diseases yes | 0 Participants | 2 Participants | 2 Participants |
| WBC | 6.9 g/dl STANDARD_DEVIATION 2 | 7.6 g/dl STANDARD_DEVIATION 2.1 | 7.25 g/dl STANDARD_DEVIATION 2.05 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 51 | 0 / 50 |
| other Total, other adverse events | 0 / 51 | 0 / 50 |
| serious Total, serious adverse events | 0 / 51 | 0 / 50 |
Outcome results
Primary
Early Feeding
Feeding 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.
Time frame: up to 6 hours postoperatively
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LOS in ERAS Group | Early Feeding | 44 Participants |
| LOS in Non-ERAS Group | Early Feeding | 2 Participants |
Primary
Length of Hospital Stay (LOS)
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).
Time frame: up to 30 postoperative days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| LOS in ERAS Group | Length of Hospital Stay (LOS) | 3.8 days |
| LOS in Non-ERAS Group | Length of Hospital Stay (LOS) | 5.9 days |
Primary
Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively
The 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).
Time frame: within the first 18 hours after the surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LOS in ERAS Group | Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively | 48 Participants |
| LOS in Non-ERAS Group | Number of Participants With the Ability of Full Mobilization Within 18h Postoperatively | 9 Participants |
Primary
Number of Participants With the Ability to Getting up in a Chair Within 18h
The number of participants who had the ability to have a sit steadily on a chair himself, within the first 18 hours after the surgery.
Time frame: within the first 18 postoperative hours
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LOS in ERAS Group | Number of Participants With the Ability to Getting up in a Chair Within 18h | 46 Participants |
| LOS in Non-ERAS Group | Number of Participants With the Ability to Getting up in a Chair Within 18h | 5 Participants |
Primary
Pain Levels
Evaluation 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.
Time frame: up to 3 postoperative days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LOS in ERAS Group | Pain Levels | 3.6 units on a scale | Standard Deviation 1 |
| LOS in Non-ERAS Group | Pain Levels | 4.6 units on a scale | Standard Deviation 1.2 |
Secondary
Blood Transfusion
Number of participants who had blood transfusion during their intraoperative and postoperative time
Time frame: within 48 hours post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LOS in ERAS Group | Blood Transfusion | 0 Participants |
| LOS in Non-ERAS Group | Blood Transfusion | 9 Participants |
Secondary
Early Discontinuation of IV Administration
Number of participants who had early discontinuation of IV fluids and conversion to per os within 24 hours postoperatively
Time frame: within 24 h post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LOS in ERAS Group | Early Discontinuation of IV Administration | 41 Participants |
| LOS in Non-ERAS Group | Early Discontinuation of IV Administration | 2 Participants |
Secondary
Early Mobilization of the Digestive System
Number of participants who had their digestive system function on time, with hunger, bowel sounds and bowel movements within the first 24 hours postoperatively
Time frame: within 24 hours post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LOS in ERAS Group | Early Mobilization of the Digestive System | 46 Participants |
| LOS in Non-ERAS Group | Early Mobilization of the Digestive System | 8 Participants |
Secondary
Number of Participants Who Had Their Drainage Removal Within 24h
Number of Participants who had their drainage removal within 24 hours postoperatively
Time frame: within 24h post surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LOS in ERAS Group | Number of Participants Who Had Their Drainage Removal Within 24h | 48 Participants |
| LOS in Non-ERAS Group | Number of Participants Who Had Their Drainage Removal Within 24h | 16 Participants |
Secondary
Number of Participants Who Had Their Urinary Catheter Removal
Number of participants who had their urinary catheter removed within 24 hours postoperatively
Time frame: within the first 24h after surgery
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LOS in ERAS Group | Number of Participants Who Had Their Urinary Catheter Removal | 43 Participants |
| LOS in Non-ERAS Group | Number of Participants Who Had Their Urinary Catheter Removal | 6 Participants |
Secondary
Postoperative Complications
The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.
Time frame: up to 5 postoperative days
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LOS in ERAS Group | Postoperative Complications | vomiting | 9 participants |
| LOS in ERAS Group | Postoperative Complications | fever | 1 participants |
| LOS in ERAS Group | Postoperative Complications | repression | 2 participants |
| LOS in ERAS Group | Postoperative Complications | urinary tract infection | 0 participants |
| LOS in ERAS Group | Postoperative Complications | somnolence | 4 participants |
| LOS in ERAS Group | Postoperative Complications | re-operation | 1 participants |
| LOS in ERAS Group | Postoperative Complications | bleeding | 1 participants |
| LOS in ERAS Group | Postoperative Complications | postoperative bilirubin | 11 participants |
| LOS in ERAS Group | Postoperative Complications | nausea | 16 participants |
| LOS in Non-ERAS Group | Postoperative Complications | postoperative bilirubin | 16 participants |
| LOS in Non-ERAS Group | Postoperative Complications | nausea | 22 participants |
| LOS in Non-ERAS Group | Postoperative Complications | vomiting | 18 participants |
| LOS in Non-ERAS Group | Postoperative Complications | somnolence | 17 participants |
| LOS in Non-ERAS Group | Postoperative Complications | repression | 10 participants |
| LOS in Non-ERAS Group | Postoperative Complications | bleeding | 5 participants |
| LOS in Non-ERAS Group | Postoperative Complications | fever | 11 participants |
| LOS in Non-ERAS Group | Postoperative Complications | urinary tract infection | 4 participants |
| LOS in Non-ERAS Group | Postoperative Complications | re-operation | 2 participants |
Secondary
Readmission
Readmission rate by 30 days after discharge from the hospital
Time frame: up to 30 postoperative days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| LOS in ERAS Group | Readmission | 0 participants |
| LOS in Non-ERAS Group | Readmission | 1 participants |