Clinical trial NCT02687412: Fast-track Surgery After Gynecological Oncology Surgery
Official title: Fast-track Surgery After Gynaecological Oncological Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Length of Stay
Postoperative Complications
CRP
Keywords: Fast-track surgery
Gynecological oncology
Hospitalization post-operation
Complication
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2016-02-22
Enrollment: 107
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomised controlled trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: Methods/Design

Comparison of Fast-Track (FT) and traditional management protocols. the primary endpoints is length of hospitalization post-operation (d, mean±SD). It was calculated by the difference between date of discharge and date of surgery. The secondary endpoints are complications in both groups are assessed during the first 21 days postoperatively. Including infection(wound infection, lung infection, intraperitoneal infection, operation space infection), postoperative nausea and vomiting (PONV) , ileus, postoperative hemorrhage, postoperative thrombosis and APACHE II score.

The advantages of fast-track most likely extend to gynecology, although so far have scarcely been reported. NO randomised controlled trials for now. The aim of this study is to compare the LOS (Length of hospitalization post-operation) after the major gynaecological/gynaecological oncologic surgery and analyze the complication after surgery. This trial can show whether the FTS program can achieve early hospital discharge after gynaecological surgery meanwhile with low levels of complications.

Eligibility criteria: Inclusion Criteria:

1. Patients scheduled for gynecological oncology surgery(including radical hysterectomy add lymphadenectomy, hysterectomy add lymphadenectomy and cytoreductive)
2. Aged 18 years or older
3. Signed informed consent provided

Exclusion Criteria:

1. Patients with a documented infection at the time of operation
2. Aged 71 years or older
3. Patients with ileus at the time of operation
4. Patients with hypocoagulability
5. Patients with psychosis, Alcohol dependence or drug abuse history
6. Patients with primary nephrotic or hepatic disease
7. Patients with severe hypertension systolic pressure≥160mmHg, diastolic pressure\>90mmHg

Primary outcomes:
measure: Length of Hospitalization Post-operation
timeFrame: up to 12 months
measure: The Total Cost (RMB)
timeFrame: 12 month
Secondary outcomes:
measure: CRP
timeFrame: up to 12 months
measure: Number of Participants With Complications
timeFrame: up to 12 months
measure: Number of Participants With Infection,
timeFrame: up to 12 months
measure: Number of Participants With Postoperative Nausea and Vomiting (PONV)
timeFrame: up to 12 months
measure: Number of Participants With Ileus
timeFrame: up to 12 months
measure: Number of Participants With Postoperative Haemorrhage
timeFrame: up to 12 months
measure: Number of Participants With Postoperative Thrombosis
timeFrame: up to 12 months
measure: PCT Calcitonin Postoperative
timeFrame: 12 month
measure: Cost of Surgical Therapy
timeFrame: 12 month
Other outcomes:
Locations:
city: Leshan
country: China
facility: LinShuangfeng
state: Sichuan
Study officials:
affiliation: Sichuan Cancer Hospital and Research Institute
name: Ling Cui, MD
role: STUDY_CHAIR
affiliation: Sichuan Cancer Hospital and Research Institute
name: Yu Shi
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Cancer Hospital and Research Institute
name: Hong Liu
role: PRINCIPAL_INVESTIGATOR
affiliation: Sichuan Cancer Hospital and Research Institute
name: Dengfeng Wang
role: PRINCIPAL_INVESTIGATOR
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