N/A
Completed N=107
Fast-track Surgery After Gynecological Oncology Surgery
Length of Stay · Postoperative Complications · CRP
Source: ClinicalTrials.gov NCT02687412 ↗
Enrolled (actual)
107
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Length of Hospitalization Post-operation — 8.92; 9.67 days — p=0.141
Summary
Fast-track surgery (FTS) pathway, also known as enhanced recovery after surgery (ERAS), FTS is a multidisciplinary approach aiming to accelerate recovery, reduce complications, minimize hospital stay without an increased readmission rate and reduce healthcare costs, all without compromising patient safety. It has been used successfully in non-malignant gynecological surgery, but it has been proven to be especially effective in elective colorectal surgery. However, no consensus guideline has been developed for gynecological oncology surgery although surgeons have attempted to introduce slightly modified FTS programmes for patients undergoing such surgery. NO randomised controlled trials for now.
The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. There is a existing research showed FTS in gynecological oncology provide early hospital discharge after gynaecological surgery meanwhile with high levels of patient satisfaction.
The aim of this study is to identify patients following a FTS program who have been discharged earlier than anticipated after major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Length of Hospitalization Post-operation |
8.92; 9.67 | 0.141 |
| PRIMARY The Total Cost (RMB) |
38882.44; 42864.12 | 0.029 sig |
| SECONDARY CRP |
42.125; 62.499 | 0.002 sig |
| SECONDARY Number of Participants With Complications |
3; 13 | 0.014 sig |
| SECONDARY Number of Participants With Infection, |
2; 12 | 0.034 sig |
| SECONDARY Number of Participants With Postoperative Nausea and Vomiting (PONV) |
0; 0 | 1 |
| SECONDARY Number of Participants With Ileus |
1; 1 | 1 |
| SECONDARY Number of Participants With Postoperative Haemorrhage |
0; 0 | 1 |
| SECONDARY Number of Participants With Postoperative Thrombosis |
0; 0 | 1 |
| SECONDARY PCT Calcitonin Postoperative |
0.6275; 0.7280 | 0.601 |
| SECONDARY Cost of Surgical Therapy |
9703.22; 9538.47 | 0.605 |
Eligibility Criteria
Inclusion Criteria
- Patients scheduled for gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, hysterectomy add lymphadenectomy and cytoreductive)
- Aged 18 years or older
- Signed informed consent provided
Exclusion Criteria
- Patients with a documented infection at the time of operation
- Aged 71 years or older
- Patients with ileus at the time of operation
- Patients with hypocoagulability
- Patients with psychosis, Alcohol dependence or drug abuse history
- Patients with primary nephrotic or hepatic disease
- Patients with severe hypertension systolic pressure≥160mmHg, diastolic pressure>90mmHg
Data sourced from ClinicalTrials.gov (NCT02687412). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.