Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05894408 |
| Other study ID # |
SHDC22020204 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
June 15, 2023 |
| Est. completion date |
August 1, 2023 |
Study information
| Verified date |
April 2024 |
| Source |
Shanghai Zhongshan Hospital |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
Postoperative nausea and vomiting (PONV) is one of the most common and distressing
postoperative complications. PONV risk assessment is recommanded to determine the number of
medications or strategies for prophylaxis. Many well-known risk factors have been determined.
However, no study has explored liver surgery-specific risk factors. This study aims to
identify whether there was an association between portal vein occlusion and PONV among
patients after liver surgery. Patients diagnosed with liver cancer and undergoing hepatectomy
will be prospectively consecutively recruited. All enrolled patients receive PONV assessments
within the first 24 postoperative hours. Logistic regression models will be used to
investigate the effects of portal vein occlusion and the other variables on the occurrence of
PONV in both univariate and multivariate analyses
Description:
1. Design This is a single-centre, prospective cohort study performed at a tertiary
teaching hospital in Shanghai, China.
2. Participants We calculated the sample size based on the rule-of-thumb method from
logistic modelling as follows: a minimum of 10 events per predictor variable should be
achieved based on simulation studies. The reported incidence of PONV among patients
undergoing general surgery ranged from 30% to 50%. We used the lowest incidence of 30%
to estimate the sample size. The expected variable number included in the logistic model
was 9, and adjusting for a 10% of loss to follow-up, the sample size was 330.
Patients will be prospectively consecutively recruited. Patients who are diagnosed with
liver cancer and underwent hepatectomy are eligible. Inclusion criteria are age older
than 18 years, planned admissions and elective surgery, and staying at least 24 hours in
the surgical unit. We exclude patients with cognitive impairment and patients who had
nausea and vomiting related to other existing diseases, such as gastroesophageal reflux
disease. We also exclude patients who have severe postoperative complications, including
massive abdominal hemorrhage, hepatic encephalopathy and portal vein thrombosis.
3. Setting The study will be conducted in the liver disease department in Zhongshan
Hospital, Shanghai, China, which is the largest liver surgery department in eastern
China. In 2018, the department performs nearly 3000 liver surgeries. The liver surgical
department has 240 beds, and the department staff includes 106 nurses and physicians.
4. Data collection 4.1 Preoperative assessment All enrolled patients will receive
preoperative assessments by trained investigators. The baseline demographic data and
medical history will be recorded. We define smoking history as nicotine use before
surgery, and history of motion sickness as nausea or vomiting when travelling in a
car/boat/train/plane. Nonsmoking and history of motion sickness or PONV will be
collected by interviewing patients and family members.
4.2 Postoperative assessment All enrolled patients receive postoperative assessments by
trained nurses. The use of postoperative opioids and the length of surgery are
determined by checking the hospital information system to review surgery records and
anaesthetic protocols within 24 hours after surgery. The time of portal vein occlusion
will be recorded by the surgeon.
5. Surgery and postoperative management A standard general anaesthesia technique is used
for all patients. Different operations are performed according to the preoperative
conditions of each patient. S
6. Outcome measures Postoperative nausea and vomiting will be assessed hourly during the
first two hours, every two hours for the following four hours and every four hours until
the 24th hour by the first and the second authors to ensure high-quality data
collection. PONV will be evaluated on a four-grade scale from 0 (no nausea and no
vomiting), 1 (having nausea but no vomiting), 2 (having vomiting without stomach
contents ) to 3 (having vomiting with stomach contents). A patient will be considered to
have PONV if his or her PONV grade is 2 or more within the first 24 postoperative hours.
PONV will be assessed by the first author, who is blinded to the result of portal vein
occlusion.
7. Statistical analysis Statistical analyses are conducted using IBM-SPSS software version
22 (IBM Corp., Armonk, NY, USA), Empower (R) (www.empowerstats.com, X&Y solutions, Inc.,
Boston, MA), and R statistical software. Data are presented as the mean and standard
deviation for continuous variables and as percentages for categorical variables.
Normally distributed continuous variables are compared using one-way analysis of
variance. The Pearson χ2 test is applied to all categorical variables. Logistic
regression models are used to investigate the effects of portal vein occlusion and the
other variables on the occurrence of PONV in both univariate and multivariate analyses.
Independent variables are selected based on evidence from previous studies showing a
significant relation to PONV and we also include other variables based on our clinical
experience.
