Laparoscopic SurgeryNCT04935216
Predictors of Postoperative Complications and Readmissions in Laparoscopic Pancreas Resection
An observational study of Laparoscopic Surgery and Pancreas, run by Clinica Universidad de Navarra, Universidad de Navarra.
Trial summary
Laparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy. The objective of this study is to analyze the factors that predict postoperative complications and hospital readmission in a series of laparoscopic pancreatectomies. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Laparoscopic Surgery, Pancreas
- What is being tested?
- Laparoscopic
- Type of treatment
- Surgery or procedure
- How many people
- 105 participants
- Where
- No sites listed yet
- Study dates
- Jan 2000to Dec 2020
- 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: All consecutive patients undergoing laparoscopic resection of the pancreas between 2000 and 2020 in the Clínica Universidad de Navarra
Who may be able to join
- A retrospective study was carried out using data from a prospective database of all consecutive patients undergoing laparoscopic resection of the pancreas between 2000 and 2020 in the Clínica Universidad de Navarra
Who cannot join
- n/a
About this study
Official title: Predictors of Postoperative Complications and Readmissions in Laparoscopic Pancreas Resection: Results of 105 Consecutive Cases
Laparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy. The objective of this study is to analyze the factors that predict postoperative complications and hospital readmission in a series of laparoscopic pancreatectomies.
Read the detailed description
The investigators conducted a retrospective study using a prospective database of laparoscopic resections performed between 2000 and 2020. Data were collected on age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, type of surgery, histologic type, operative time, hospital stay, postoperative complications, degree of severity and hospital readmission
- Conditions
- Laparoscopic Surgery, Pancreas
- Being tested
- Laparoscopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LaparoscopicProcedure or surgery
Laparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation of Gender, Age, body mass index with the outcomes
The investigators evaluate multiple variables in relation in the designed outcomes: Gender, Age, body mass index (weight and height will be combined to report BMI in kg/m^2)
Measured: 20 years
Readmission
Readmission defined as an admission to any hospital for 24 hours or more for any reason within 60 days of surgery
Measured: 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2021
- Study startJan 2000
- Primary completionOct 2020
- Study completionDec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de Navarra
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935216
- Sponsor's protocol ID
- LAPAN
- Status last verified
- Jun 2021
- First submitted
- 7 May 2021
- Last updated
- 22 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- 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 22 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictors of Postoperative Complications and Readmissions in Laparoscopic Pancreas Resection: Results of 105 Consecutive Cases
- ClinicalTrials.gov ID
- NCT04935216
- Acronym / sponsor ID
- LAPAN
- Conditions
- Laparoscopic Surgery, Pancreas
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Clinica Universidad de Navarra, Universidad de NavarraUniversity, hospital or other
- Study start
- Jan 2000 (actual)
- Primary completion
- Oct 2020 (actual)
- Study completion
- Dec 2020 (actual)
- First posted
- 22 Jun 2021 (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.
Laparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy. The objective of this study is to analyze the factors that predict postoperative complications and hospital readmission in a series of laparoscopic pancreatectomies.
Detailed description
The investigators conducted a retrospective study using a prospective database of laparoscopic resections performed between 2000 and 2020. Data were collected on age, gender, body mass index (BMI), American Society of Anesthesiology (ASA) score, type of surgery, histologic type, operative time, hospital stay, postoperative complications, degree of severity and hospital readmission
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients undergoing laparoscopic resection of the pancreas between 2000 and 2020 in the Clínica Universidad de Navarra
Key inclusion criteria (1 listed)
- A retrospective study was carried out using data from a prospective database of all consecutive patients undergoing laparoscopic resection of the pancreas between 2000 and 2020 in the Clínica Universidad de Navarra
Key exclusion criteria (1 listed)
- n/a
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 |
|---|---|---|
| LaparoscopicLaparoscopic resection of the pancreas has become widely accepted in the treatment of lesions which are benign or of low-grade malignancy | Procedure or surgery | – |
Primary outcome
Correlation of Gender, Age, body mass index with the outcomes
Time frame: 20 years
The investigators evaluate multiple variables in relation in the designed outcomes: Gender, Age, body mass index (weight and height will be combined to report BMI in kg/m^2)
Readmission
Time frame: 60 days
Readmission defined as an admission to any hospital for 24 hours or more for any reason within 60 days of surgery
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 22 Jun 2021.
- 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Surgery and Pancreas, run by Clinica Universidad de Navarra, Universidad de Navarra.
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 22 Jun 2021. 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?
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?
Correlation of Gender, Age, body mass index with the outcomes (time frame: 20 years). The study lists 2 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 22 Jun 2021.