CRP, Length of Stay, Postoperative Complications
Conditions
Keywords
Fast-track surgery, Gynecological oncology, Hospitalization post-operation, Complication
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.
Interventions
PROCEDUREpre-operative assessment, counseling and education
pre-operative assessment, counseling and FT management education
PROCEDUREPreoperative nutritional drink up to 4 h prior to surgery
Preoperative nutritional drink up to 4 h prior to surgery mechanical bowl preparation should not be used
PROCEDUREbowel preparation
patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool
PROCEDUREpreoperative treatment with carbohydrates
preoperative treatment with carbohydrates (patients without diabetes).
PROCEDUREfast solid
fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia;
PROCEDUREavoiding hypothermia
avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.
PROCEDUREPostoperative glycaemic control
Postoperative glycaemic control;
PROCEDUREpostoperative nausea and vomiting (PONV) control;
PROCEDUREearly postoperative diet
early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet).
PROCEDUREpre-operative fasting at least 8h
PROCEDUREbowel preparation for traditional surgery
Oral bowel preparations or mechanical bowl until liquid stool
PROCEDUREbegan to take solid diet after anal exhaust
6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust
Sponsors
Ling Cui
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Patients were randomly divided into two groups（ FTS group/traditional group）, after that doctors and patients were aware of the grouping situation.
Intervention model description
prospective randomised controlled trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Length of Hospitalization Post-operation | up to 12 months | days from operation date to discharge date |
| The Total Cost (RMB) | 12 month | The total cost from hospitalization |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Infection, | up to 12 months | infection(wound infection, lung infection, intraperitoneal infection, operation space infection) |
| Number of Participants With Postoperative Nausea and Vomiting (PONV) | up to 12 months | it was recognized that nausea and vomiting are common side effects of surgical recovery |
| Number of Participants With Ileus | up to 12 months | is a disruption of the normal propulsive ability of the gastrointestinal tract |
| CRP | up to 12 months | C-Reactive protein mg/L |
| Number of Participants With Postoperative Thrombosis | up to 12 months | Evidence of blood thrombosis of participants after surgery |
| PCT Calcitonin Postoperative | 12 month | value of calcitonin postoperative |
| Cost of Surgical Therapy | 12 month | Cost of surgical therapy (RMB) |
| Number of Participants With Postoperative Haemorrhage | up to 12 months | Evidence of blood loss from drains or based on ultrasonography |
| Number of Participants With Complications | up to 12 months | Count of patients with 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. |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Fast-track Surgery Pre-operative: pre-operative assessment, counseling and FT management education; preoperative nutritional drink up to 4 h prior to surgery; mechanical bowl preparation should not be used; patients are not received mechanical bowel preparation, only oral intestinal cleaner 12 h pre-operation can be accepted, but no need of liquid stool; antimicrobial prophylaxis and skin preparation; preoperative treatment with carbohydrates (patients without diabetes).
Intraoperative : fast solid food before 6 h and liquid food Intake of clear fluids 2 h before anaesthesia; avoiding hypothermia, keeping the intra-operative lowtemperature at 36 ±0.5 degree centigrade; antiemetics at end of anaesthesia.
Post-operative : Postoperative glycaemic control; postoperative nausea and vomiting (PONV) control; early postoperative diet(3-6 h after surgery, patients resumed a liquid diet, 12 h after surgery patients began to take solid diet). | 50 |
| Traditional Surgery pre-operative assessment：pre-operative fasting at least 8h, oral bowel preparation or, Antimicrobial prophylaxis and skin preparation or mechanical bowl until liquid stool Intraoperative: keeping the intra-operative lowtemperature at 34.7±0.6 degree centigrade.
Post-operative: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust
pre-operative fasting at least 8h
Oral bowel preparations: Oral bowel preparations or mechanical bowl until liquid stool
intra-operative lowtemperature at 34.7 ±0.6 degree centigrade: keeping the intra-operative lowtemperature at 34.7 ±0.6 degree centigrade
began to take solid diet after anal exhaust: 6 h after surgery, patients resumed a liquid diet, patients began to take solid diet after anal exhaust | 57 |
| Total | 107 |
Baseline characteristics
| Characteristic | Fast-track Surgery | Traditional Surgery | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 4 Participants | 7 Participants |
| Age, Categorical Between 18 and 65 years | 47 Participants | 53 Participants | 100 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 9.7 | 50 years STANDARD_DEVIATION 10.52 | 49 years STANDARD_DEVIATION 10.1 |
| Body Mass Index | 22.681 kg/m^2 STANDARD_DEVIATION 4.1774 | 23.165 kg/m^2 STANDARD_DEVIATION 3.2728 | 22.939 kg/m^2 STANDARD_DEVIATION 3.7722 |
| Body surface area | 1.5462 m^2 STANDARD_DEVIATION 0.11873 | 1.5362 m^2 STANDARD_DEVIATION 0.1155 | 1.5409 m^2 STANDARD_DEVIATION 0.11658 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment China | 50 participants | 57 participants | 107 participants |
| Sex: Female, Male Female | 50 Participants | 57 Participants | 107 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 50 | 0 / 57 |
| other Total, other adverse events | 0 / 50 | 0 / 57 |
| serious Total, serious adverse events | 0 / 50 | 0 / 57 |
Outcome results
Primary
Length of Hospitalization Post-operation
days from operation date to discharge date
Time frame: up to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast-track Surgery | Length of Hospitalization Post-operation | 8.92 days | Standard Deviation 2.029 |
| Traditional Surgery | Length of Hospitalization Post-operation | 9.67 days | Standard Deviation 3.119 |
p-value: 0.141t-test, 2 sided
Primary
The Total Cost (RMB)
The total cost from hospitalization
Time frame: 12 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast-track Surgery | The Total Cost (RMB) | 38882.44 RMB | Standard Deviation 8557.8 |
| Traditional Surgery | The Total Cost (RMB) | 42864.12 RMB | Standard Deviation 10166.535 |
p-value: 0.02995% CI: [-7672.301, -411.065]t-test, 2 sided
Secondary
Cost of Surgical Therapy
Cost of surgical therapy (RMB)
Time frame: 12 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast-track Surgery | Cost of Surgical Therapy | 9703.22 RMB | Standard Deviation 1739.157 |
| Traditional Surgery | Cost of Surgical Therapy | 9538.47 RMB | Standard Deviation 1548.385 |
p-value: 0.60595% CI: [-465, 794]t-test, 2 sided
Secondary
CRP
C-Reactive protein mg/L
Time frame: up to 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast-track Surgery | CRP | 42.125 mg/L | Standard Deviation 28.4284 |
| Traditional Surgery | CRP | 62.499 mg/L | Standard Deviation 37.787 |
p-value: 0.00295% CI: [7.6414, 33.1065]t-test, 2 sided
Secondary
Number of Participants With Complications
Count of patients with 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.
Time frame: up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fast-track Surgery | Number of Participants With Complications | 3 Participants |
| Traditional Surgery | Number of Participants With Complications | 13 Participants |
p-value: 0.014Chi-squared
Secondary
Number of Participants With Ileus
is a disruption of the normal propulsive ability of the gastrointestinal tract
Time frame: up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fast-track Surgery | Number of Participants With Ileus | 1 Participants |
| Traditional Surgery | Number of Participants With Ileus | 1 Participants |
p-value: 1Chi-squared
Secondary
Number of Participants With Infection,
infection(wound infection, lung infection, intraperitoneal infection, operation space infection)
Time frame: up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fast-track Surgery | Number of Participants With Infection, | 2 Participants |
| Traditional Surgery | Number of Participants With Infection, | 12 Participants |
p-value: 0.034Chi-squared
Secondary
Number of Participants With Postoperative Haemorrhage
Evidence of blood loss from drains or based on ultrasonography
Time frame: up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fast-track Surgery | Number of Participants With Postoperative Haemorrhage | 0 Participants |
| Traditional Surgery | Number of Participants With Postoperative Haemorrhage | 0 Participants |
p-value: 1Chi-squared
Secondary
Number of Participants With Postoperative Nausea and Vomiting (PONV)
it was recognized that nausea and vomiting are common side effects of surgical recovery
Time frame: up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fast-track Surgery | Number of Participants With Postoperative Nausea and Vomiting (PONV) | 0 Participants |
| Traditional Surgery | Number of Participants With Postoperative Nausea and Vomiting (PONV) | 0 Participants |
p-value: 1Chi-squared
Secondary
Number of Participants With Postoperative Thrombosis
Evidence of blood thrombosis of participants after surgery
Time frame: up to 12 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Fast-track Surgery | Number of Participants With Postoperative Thrombosis | 0 Participants |
| Traditional Surgery | Number of Participants With Postoperative Thrombosis | 0 Participants |
p-value: 1Chi-squared
Secondary
PCT Calcitonin Postoperative
value of calcitonin postoperative
Time frame: 12 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Fast-track Surgery | PCT Calcitonin Postoperative | 0.6275 μg/L | Standard Deviation 0.90827 |
| Traditional Surgery | PCT Calcitonin Postoperative | 0.7280 μg/L | Standard Deviation 0.89083 |
p-value: 0.60195% CI: [-0.4819, 0.2817]t-test, 2 sided