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Enhanced recovery programs are composed of preoperative, intraoperative and postoperative strategies combined to form a multi-modal pathway. ERAS requires a multidisciplinary team of anesthetists, surgeons and nurses for successful implementation and realization of its advantages.The aim of this study is to compare outcomes of conventional perioperative care with those of an enhanced recovery after surgery (ERAS) perioperative care plan in women undergoing surgery for gynecologic cancer or suspected gynecologic disease.
The study design is a two-arm, randomized, controlled trial. The control arm will consist of standard conventional perioperative care. The intervention arm will consist of a protocol-driven ERAS program. The investigators believe that this information will be very useful because although there is a national interest in creating ERAS protocols for gynecology, there currently is very little published on the subject. Investigators hypothesize that those patients randomized to the ERAS protocol will have shorter lengths of hospital stay and complications, without increasing readmission rates. The investigators would like to publish the investigators' results and protocol as a resource for other institutions to adopt.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Perioperative (SP) care | No Intervention | Conventional Perioperative (SP) care | |
| ERAS protocol | Experimental | preoperative / intraoperative/ postoperative management |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ERAS protocol | Procedure | preoperative management Optimization of relevant medical uncontrolled situations, avoid fasting, avoid bowel preparation, avoid premedications, nutritional assessment, stop smoking, stop alcohol and appropriate counselling intraoperative management Multimodal prevention of prophylaxis against nausea and vomiting (PONV) (according to preoperative assessment of Apfel Score) with a combination of multiple antiemetic drugs. postoperative management Postoperative pain control is obtained with opioid sparing strategies, in order to avoid Post Operative Ileus (POI) and PONV. It is proposed to chew gum three times daily , fluid therapy, early mobilization, early feeding within 2 hours postoperative for at least 15 minutes and eventually to promote a faster bowel function. |
| Measure | Description | Time Frame |
|---|---|---|
| Shorter Length Of Hospitalization (LOH) | Total amount of days spent in hospital | Up to 4 weeks after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of postoperative pain | Measurement of pain score post-operation will be obtained using clinical data gathered by the care team providing routine clinical care, and asking routine pain score questions. The scale used is the standard 1-10 pain scale, with 1 being no pain or very mild discomfort, and 10 being very severe pain. | At moment 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Beihua Kong, MD.PhD. | Qilu Hospital of Shandong University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Qilu Hospital of Shandong University | Jinan | Shandong | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37138751 | Derived | Xing N, Wang H, Huang Y, Peng J. Enhanced recovery after surgery program alleviates neutrophil-to-lymphocyte ratio and platelet-to-lymphocyte ratio in patients undergoing gynecological surgery. Front Med (Lausanne). 2023 Apr 17;10:1057923. doi: 10.3389/fmed.2023.1057923. eCollection 2023. | |
| 34103993 | Derived |
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| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| ID | Term |
|---|---|
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
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| Presence/Absence of nausea | Treatment for postoperative nausea | At moment 0, 3, 6, 12 and 24 hours after surgery |
| Presence/Absence of vomiting | Treatment for postoperative vomiting | At moment 0, 3, 6, 12 and 24 hours after surgery |
| Time to flatus | Hours elapsed to event | Up to 4 weeks after surgery |
| Time to bowel movement | Hours elapsed to event | Up to 4 weeks after surgery |
| Foley catheter removal | Time to Foley catheter removal postoperative | From 1 to 14days post surgery |
| Time to drink | Hours elapsed to event | Up to 4 weeks after surgery |
| Time to eating | Hours elapsed to event | Up to 4 weeks after surgery |
| Time to walking | Hours elapsed to event | Up to 4 weeks after surgery |
| Postoperative complications | Rate measurement | Up to 2 weeks after surgery |
| Time to adjuvant treatment | Time participant receives adjuvant treatment, if needed (chemotherapy or radiation) | 60 days |
| Readmission rates | Readmissions to the hospital | Up to 21 days post surgery |
| Peng J, Dong R, Jiao J, Liu M, Zhang X, Bu H, Dong P, Zhao S, Xing N, Feng S, Yang X, Kong B. Enhanced Recovery After Surgery Impact on the Systemic Inflammatory Response of Patients Following Gynecological Oncology Surgery: A Prospective Randomized Study. Cancer Manag Res. 2021 Jun 1;13:4383-4392. doi: 10.2147/CMAR.S294718. eCollection 2021. |