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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A-ERAS | Experimental | will receive ERAS pathways care |
|
| B-nonERAS | No Intervention | will receive traditional non ERAS care |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS protocol | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | up to 30 postoperative days |
| 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. | up to 3 postoperative days |
| 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. | within the first 18 postoperative hours |
| 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). | within the first 18 hours after the surgery |
| 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. | up to 6 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | within 24 hours post surgery |
| Early Discontinuation of IV Administration |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| MARIA BOURAZANI, PhD | Saint Savvas Anticancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint Savvas Anticancer Hospital | Athens | Attica | 11522 | Greece |
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| Label | URL |
|---|---|
| Original Paper | View source |
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After obtaining consent, participants were screened for for study inclusion criteria. If entry criteria were passed they were randomized to the study.
Participants were recruited between January 2020 and December 2021 from a General Anticancer Oncology Centre of Athens, Greece.
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| ID | Title | Description |
|---|---|---|
| FG000 | A-ERAS | N=51 following the ERAS protocol |
| FG001 | B-Non ERAS | N=50 following a conventional post-op care |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A-ERAS | following the ERAS protocol |
| BG001 | B-Non ERAS | following a conventional post-op care |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Inter-Quartile Range | days | up to 30 postoperative days |
|
Initial 30 postoperative days following surgical intevention
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Number of Adverse Events in ERAS Group | Number of adverse events in participants following the ERAS protocol |
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The limitations of the study could be the sample size (101 participants), but due to the COVID-19 pandemic where the annual number of surgeries was necessarily reduced, this number of participants is completely satisfactory.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Maria Bourazani | Saint Savvas Hospital of Athens | +302106409000 | mbourazani@yahoo.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 11, 2019 | Mar 25, 2025 | Prot_SAP_ICF_001.pdf |
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| ID | Term |
|---|---|
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
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|
Number of participants who had early discontinuation of IV fluids and conversion to per os within 24 hours postoperatively |
| within 24 h post surgery |
| Number of Participants Who Had Their Urinary Catheter Removal | Number of participants who had their urinary catheter removed within 24 hours postoperatively | within the first 24h after surgery |
| Number of Participants Who Had Their Drainage Removal Within 24h | Number of Participants who had their drainage removal within 24 hours postoperatively | within 24h post surgery |
| Blood Transfusion | Number of participants who had blood transfusion during their intraoperative and postoperative time | within 48 hours post surgery |
| Postoperative Complications | The evaluation of postoperative complications such as bleeding, thrombosis and inflammation. | up to 5 postoperative days |
| Readmission | Readmission rate by 30 days after discharge from the hospital | up to 30 postoperative days |
| BG002 |
| Total |
Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Participants were only female | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Marital status | Count of Participants | Participants |
|
| Number of Children | Count of Participants | Participants |
|
| educational level | Count of Participants | Participants |
|
| Profession | Count of Participants | Participants |
|
| Smoking | Count of Participants | Participants |
|
| alcohol consumption | Count of Participants | Participants |
|
| endocrinological diseases | Count of Participants | Participants |
|
| Urinary tract diseases | Count of Participants | Participants |
|
| kidney or liver disease | Count of Participants | Participants |
|
| Cardiovascular diseases | Count of Participants | Participants |
|
| Diseases of the respiratory system | Count of Participants | Participants |
|
| Diseases of the digestive system | Count of Participants | Participants |
|
| nervous system diseases | Count of Participants | Participants |
|
| Skin diseases | Count of Participants | Participants |
|
| other malignancy | Count of Participants | Participants |
|
| Allergies | Count of Participants | Participants |
|
| Hemoglobin | Mean | Standard Deviation | g/dl |
|
| Hematocrit | Mean | Standard Deviation | percentage % of red blood cells in blood |
|
| WBC | Mean | Standard Deviation | g/dl |
|
| Glucose | Mean | Standard Deviation | mg/dl |
|
| Plasma proteins | Mean | Standard Deviation | g/dl |
|
| Albumin | Mean | Standard Deviation | g/dl |
|
| Units | Counts |
|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | up to 3 postoperative days |
|
|
|
| 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. | Posted | Count of Participants | Participants | within the first 18 postoperative hours |
|
|
|
| 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). | Posted | Count of Participants | Participants | within the first 18 hours after the surgery |
|
|
|
| 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. | Posted | Count of Participants | Participants | up to 6 hours postoperatively |
|
|
|
| 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 | Posted | Count of Participants | Participants | within 24 hours post surgery |
|
|
|
| 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 | Posted | Count of Participants | Participants | within 24 h post surgery |
|
|
|
| Secondary | Number of Participants Who Had Their Urinary Catheter Removal | Number of participants who had their urinary catheter removed within 24 hours postoperatively | Posted | Count of Participants | Participants | within the first 24h after surgery |
|
|
|
| Secondary | Number of Participants Who Had Their Drainage Removal Within 24h | Number of Participants who had their drainage removal within 24 hours postoperatively | Posted | Count of Participants | Participants | within 24h post surgery |
|
|
|
| Secondary | Blood Transfusion | Number of participants who had blood transfusion during their intraoperative and postoperative time | Posted | Count of Participants | Participants | within 48 hours post surgery |
|
|
|
| Secondary | Postoperative Complications | The evaluation of postoperative complications such as bleeding, thrombosis and inflammation. | Posted | Number | participants | up to 5 postoperative days |
|
|
|
| Secondary | Readmission | Readmission rate by 30 days after discharge from the hospital | Posted | Number | participants | up to 30 postoperative days |
|
|
|
| 0 |
| 51 |
| 0 |
| 51 |
| 0 |
| 51 |
| EG001 | Number of Adverse Events in Non-ERAS Group | Number of adverse events in participants following the convectional post-op care | 0 | 50 | 0 | 50 | 0 | 50 |
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| D000291 |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |
| somnolence |
|
| repression |
|
| bleeding |
|
| fever |
|
| urinary tract infection |
|
| re-operation |
|
| postoperative bilirubin |
|