Gastrointestinal DysfunctionNCT03383562
Daytime Variation of Complication in Gastric and Pancreatic Surgery
An observational study of Gastrointestinal Dysfunction and Hemorrhage, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
Trial summary
Evaluate the daytime variation of complications in gastric and pancreatic surgery Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastrointestinal Dysfunction, Hemorrhage, Infection
- What is being tested?
- operation in different stages of the day
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Jun 2018
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who meet the inclusion criteria will be enrolled in this study and then will be arranged at morning ,afternoon or night group at random.
Who may be able to join
- Patients who will undergo gastric or pancreatic surgery in our department.
- Voluntary participation, Signing informed consent and have good compliance.
Who cannot join
- Patient who attended other clinical trials in the last two months.
- Patient who will undergo multiple organs resection.
- Patient who has been taken anticoagulant recently.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Daytime Variation of Complication in Gastric and Pancreatic Surgery : a Single Center Randomized Study
Evaluate the daytime variation of complications in gastric and pancreatic surgery
Read the detailed description
The trial is funded by Cancer Foundation of China. The trial is prepared to be registered on the clinicaltrails.gov. Quality assurance plan: every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences. Data check: the investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.
Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 200 participants to take part in the trail.
The investigators can recruit about 600 participants every year according to previous experiences, so the investigators should recruit at least for half a year. Plan for missing data: the investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results. Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of complications between the three groups, and the local control rate of the three groups would be compared by chi square test. Statistical analyses would be performed by using International Business Machine Statistical Product and Service Solutions Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P < 0.05.
- Conditions
- Gastrointestinal Dysfunction, Hemorrhage, Infection, Fistula
- Being tested
- operation in different stages of the day
- Medical subject headings
- Hemorrhage, Infections, Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
operation in different stages of the dayProcedure or surgery
operation was arranged in the morning ,afternoon or at night
| Study group | Role | What they receive |
|---|---|---|
| morning group | patients in the morning group are operated during 8:30 a.m. to 2:00 p.m. Receives: Procedure: operation in different stages of the day | |
| afternoon group | patients in the morning group are operated during 2:00 p.m. to 8:00 p.m. Receives: Procedure: operation in different stages of the day | |
| night group | patients in the morning group are operated during 8:00 p.m. to 12:00 p.m. Receives: Procedure: operation in different stages of the day |
What is being measured
The primary outcome is the main question the study is designed to answer.
gastrointestinal dysfunction
using clinical symptoms to evaluate the gastrointestinal function after surgery
Measured: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first,up to 24 weeks
hemorrhage
using clinical symptoms to evaluate the gastrointestinal function after surgery
Measured: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first, up to 24 weeks
infection
using clinical symptoms to evaluate the gastrointestinal function after surgery
Measured: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first, up to 24 weeks
anastomotic fistula
using clinical symptoms to evaluate the gastrointestinal function after surgery
Measured: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first,up to 24 weeks
test rating
collecting blood sample to evaluate change of test after surgery
Measured: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first, up to 24 weeks
Secondary outcomes (1)
Physical fitness index
The recovery of physical fitness index
Measured: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first,up to 24 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jun 2018 (estimated)
- Study completion1 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DysfunctionStudies of the same condition, open and under way.
- More trials run by Cancer Institute and Hospital, Chinese Academy of Medical SciencesThe 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
- 200 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chengfeng Wang, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
- Investigators
- Chengfeng Wang, B.A., Principal investigator, Cancer Institute and Hospital, Chinese Academy of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03383562
- Sponsor's protocol ID
- CT20180101
- Status last verified
- Dec 2017
- First submitted
- 11 Dec 2017
- Last updated
- 26 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Daytime Variation of Complication in Gastric and Pancreatic Surgery : a Single Center Randomized Study
- ClinicalTrials.gov ID
- NCT03383562
- Acronym / sponsor ID
- CT20180101
- Conditions
- Gastrointestinal Dysfunction, Hemorrhage, Infection, Fistula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Cancer Institute and Hospital, Chinese Academy of Medical SciencesUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jun 2018 (estimated)
- Study completion
- 1 Jun 2018 (estimated)
- First posted
- 26 Dec 2017 (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.
Evaluate the daytime variation of complications in gastric and pancreatic surgery
Detailed description
The trial is funded by Cancer Foundation of China. The trial is prepared to be registered on the clinicaltrails.gov. Quality assurance plan: every participant is enrolled or excluded by two practiced investigators. And two investigators participated in all steps of the trail, including the record of the data, and the investigators will compare the data. If the data is consistent, the investigators would record the data; if not, the data would be checked and decided by the two investigators. All the steps and data are site monitored and audited by the workers of research and financial department of National Cancer Center/ Cancer Hospital, Chinese Academy of Medical Sciences. Data check: the investigators compare data entered into the registry against predefined rules for range or consistency with other data fields in the registry. Source data verification to assess the accuracy, completeness, or representativeness of registry data by comparing the data to external data sources, including medical records and electronic case report forms. Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, coding information, and normal ranges if relevant.
Standard Operating Procedures to address registry operations and analysis activities, such as participants recruitment, data collection, data management, data analysis, reporting for adverse events, and change management. All registry operations would be done according to specific steps, and by two practiced investigators. Sample size assessment to specify the number of participants or participant years necessary to demonstrate an effect. According to the formula to differ advantages and disadvantages, the investigators need at least 200 participants to take part in the trail.
The investigators can recruit about 600 participants every year according to previous experiences, so the investigators should recruit at least for half a year. Plan for missing data: the investigators would collect as much data as possible, and the investigators exclude the participants who cannot cooperate on recruitment. And the investigators manage situations according to statistical principles where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results. Statistical analysis plan: Kaplan-Meier method would be used to analyze the difference of complications between the three groups, and the local control rate of the three groups would be compared by chi square test. Statistical analyses would be performed by using International Business Machine Statistical Product and Service Solutions Statistics(version 20; IBM, Chicago, USA). The level of significance is defined as P < 0.05.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| morning group | – | Procedure: operation in different stages of the daypatients in the morning group are operated during 8:30 a.m. to 2:00 p.m. |
| afternoon group | – | Procedure: operation in different stages of the daypatients in the morning group are operated during 2:00 p.m. to 8:00 p.m. |
| night group | – | Procedure: operation in different stages of the daypatients in the morning group are operated during 8:00 p.m. to 12:00 p.m. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who meet the inclusion criteria will be enrolled in this study and then will be arranged at morning ,afternoon or night group at random.
Key inclusion criteria (2 listed)
- Patients who will undergo gastric or pancreatic surgery in our department.
- Voluntary participation, Signing informed consent and have good compliance.
Key exclusion criteria (3 listed)
- Patient who attended other clinical trials in the last two months.
- Patient who will undergo multiple organs resection.
- Patient who has been taken anticoagulant recently.
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 |
|---|---|---|
| operation in different stages of the dayoperation was arranged in the morning ,afternoon or at night | Procedure or surgery | afternoon group, morning group, night group |
Primary outcome
gastrointestinal dysfunction
Time frame: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first,up to 24 weeks
using clinical symptoms to evaluate the gastrointestinal function after surgery
hemorrhage
Time frame: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first, up to 24 weeks
using clinical symptoms to evaluate the gastrointestinal function after surgery
infection
Time frame: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first, up to 24 weeks
using clinical symptoms to evaluate the gastrointestinal function after surgery
anastomotic fistula
Time frame: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first,up to 24 weeks
using clinical symptoms to evaluate the gastrointestinal function after surgery
test rating
Time frame: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first, up to 24 weeks
collecting blood sample to evaluate change of test after surgery
1 secondary outcome
Physical fitness index
Time frame: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first,up to 24 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2017.
- 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.
Chengfeng Wang, B.A. principal investigator
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Dysfunction and Hemorrhage, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 26 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chengfeng Wang, B.A. (861013811370062, lifeofwater@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
gastrointestinal dysfunction (time frame: after operation from date of randomization until the date of first documented complications or date of death from any cause, whichever came first,up to 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Dec 2017.