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Implementing Enhanced Recovery After Surgery (ERAS) Pathways In Major Gynecologic Oncology Operations In Greece
NA trial testing ERAS protocol in Ovarian Cancer in 101 participants. Completed in 31 December 2023.
| Lead sponsor | University of West Attica |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | health services research |
| Enrollment | 101 |
| Start date | 6 January 2020 |
| Primary completion | 31 December 2023 |
| Estimated completion | 31 December 2023 |
| Sites | 1 location across Greece |
University of West Attica
Adults 18 to 79, female only, with Ovarian Cancer or Hysterectomy. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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).
| Group | Value | 95% CI |
|---|---|---|
| LOS in ERAS Group | 3.8 | 2 – 10 |
| LOS in Non-ERAS Group | 5.9 | 3 – 10 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Postoperative Pain Levels in ERAS Group | 3.6 | ± 1 |
| Postoperative Pain Levels in Non-ERAS Group | 4.6 | ± 1.2 |
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.
| Group | Value | 95% CI |
|---|---|---|
| Sitting -up on a Chair for Participants in ERAS Group | 46 | |
| Sitting-up on a Chair for Participants in Non-ERAS Group | 5 |
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).
| Group | Value | 95% CI |
|---|---|---|
| Standing-up in the Room for Participants in ERAS Group | 48 | |
| Standing-up in the Room for Participants in Non-ERAS Group | 9 |
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.
| Group | Value | 95% CI |
|---|---|---|
| A-ERAS | 44 | |
| B-Non ERAS | 2 |
Number of participants who had their digestive system function on time, with hunger, bowel sounds and bowel movements within the first 24 hours postoperatively
| Group | Value | 95% CI |
|---|---|---|
| A-ERAS | 46 | |
| B-Non ERAS | 8 |
Number of participants who had early discontinuation of IV fluids and conversion to per os within 24 hours postoperatively
| Group | Value | 95% CI |
|---|---|---|
| A-ERAS | 41 | |
| B-Non ERAS | 2 |
Number of participants who had their urinary catheter removed within 24 hours postoperatively
| Group | Value | 95% CI |
|---|---|---|
| ERAS Group Urinary Catheter Removal | 43 | |
| Non-ERAS Group Urinary Catheter Removal | 6 |
Number of Participants who had their drainage removal within 24 hours postoperatively
| Group | Value | 95% CI |
|---|---|---|
| A-ERAS Group | 48 | |
| B-Non ERAS Group | 16 |
Number of participants who had blood transfusion during their intraoperative and postoperative time
| Group | Value | 95% CI |
|---|---|---|
| A-ERAS | 0 | |
| B-Non ERAS | 9 |
The evaluation of postoperative complications such as bleeding, thrombosis and inflammation.
| Group | Value | 95% CI |
|---|---|---|
| Complication in ERAS Group | 16 | |
| Complications in Non-ERAS Group | 22 |
| Group | Value | 95% CI |
|---|---|---|
| Complication in ERAS Group | 9 | |
| Complications in Non-ERAS Group | 18 |
| Group | Value | 95% CI |
|---|---|---|
| Complication in ERAS Group | 4 | |
| Complications in Non-ERAS Group | 17 |
| Group | Value | 95% CI |
|---|---|---|
| Complication in ERAS Group | 2 | |
| Complications in Non-ERAS Group | 10 |
| Group | Value | 95% CI |
|---|---|---|
| Complication in ERAS Group | 1 | |
| Complications in Non-ERAS Group | 5 |
| Group | Value | 95% CI |
|---|---|---|
| Complication in ERAS Group | 1 | |
| Complications in Non-ERAS Group | 11 |
| Group | Value | 95% CI |
|---|---|---|
| Complication in ERAS Group | 0 | |
| Complications in Non-ERAS Group | 4 |
| Group | Value | 95% CI |
|---|---|---|
| Complication in ERAS Group | 1 | |
| Complications in Non-ERAS Group | 2 |
Readmission rate by 30 days after discharge from the hospital
| Group | Value | 95% CI |
|---|---|---|
| ERAS Group | 0 | |
| Non-ERAS Group | 1 |
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.
2 peer-reviewed publications reference this trial (live from Europe PMC):
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