Postoperative Nausea and VomitingNCT05894408
Portal Vein Occlusion is a Valuable Predictor for Postoperative Nausea and Vomiting
An observational study of Postoperative Nausea and Vomiting, run by Shanghai Zhongshan Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- How many people
- 380 participants
- Where
- 1 siteChina
- Study dates
- 15 Jun 2023to 1 Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who are diagnosed with liver cancer and underwent hepatectomy are eligible.
Who may be able to join
- older than 18 years, planned admissions and elective surgery, and staying at least 24 hours in the surgical unit
Who cannot join
- patients with cognitive impairment and patients who have nausea and vomiting related to other existing diseases, such as gastroesophageal reflux disease.
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Fudan University
Shanghai, Shanghai Municipality, 200032
About this study
Official title: Portal Vein Occlusion is a Valuable Predictor for Postoperative Nausea and Vomiting in Patients With Liver Cancer: A Prospective Cohort Study
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
Read the detailed description
- Design This is a single-centre, prospective cohort study performed at a tertiary teaching hospital in Shanghai, China.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- this is no intervention
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
this is no interventionOther
this is no intervention
| Study group | Role | What they receive |
|---|---|---|
| patients with portal vein occlusion | Not described Receives: Other: this is no intervention | |
| patients without portal vein occlusion | Not described Receives: Other: this is no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative nausea and vomiting
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).
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start15 Jun 2023
- Primary completion1 Aug 2023
- Study completion1 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05894408
- Sponsor's protocol ID
- SHDC22020204
- Status last verified
- Apr 2024
- First submitted
- 30 May 2023
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chen X, Zhao WJ, Yu J, Zhou H, Shi Y, Gao J, Zhang Y. Duration of hepatic portal occlusion is a valuable predictor for postoperative nausea and vomiting in patients underwent liver resection for liver cancer. BMC Cancer. 2025 Jul 16;25(1):1177. doi: 10.1186/s12885-025-14592-0.
PubMed 40670918
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Portal Vein Occlusion is a Valuable Predictor for Postoperative Nausea and Vomiting in Patients With Liver Cancer: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT05894408
- Acronym / sponsor ID
- SHDC22020204
- Conditions
- Postoperative Nausea and Vomiting
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 15 Jun 2023 (actual)
- Primary completion
- 1 Aug 2023 (actual)
- Study completion
- 1 Aug 2023 (actual)
- First posted
- 8 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
- Design This is a single-centre, prospective cohort study performed at a tertiary teaching hospital in Shanghai, China.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with portal vein occlusion | – | Other: this is no intervention |
| patients without portal vein occlusion | – | Other: this is no intervention |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who are diagnosed with liver cancer and underwent hepatectomy are eligible.
Key inclusion criteria (1 listed)
- older than 18 years, planned admissions and elective surgery, and staying at least 24 hours in the surgical unit
Key exclusion criteria (1 listed)
- patients with cognitive impairment and patients who have nausea and vomiting related to other existing diseases, such as gastroesophageal reflux disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| this is no interventionthis is no intervention | Other | patients with portal vein occlusion, patients without portal vein occlusion |
Primary outcome
Postoperative nausea and vomiting
Time frame: up to 24 hours
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2024.
- Derived from this study: PubMed 40670918Chen X, Zhao WJ, Yu J, Zhou H, Shi Y, Gao J, Zhang Y. Duration of hepatic portal occlusion is a valuable predictor for postoperative nausea and vomiting in patients underwent liver resection for liver cancer. BMC Cancer. 2025 Jul 16;25(1):1177. doi: 10.1186/s12885-025-14592-0.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postoperative Nausea and Vomiting, run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative nausea and vomiting (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05894408, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2024.