Liver and Intrahepatic Bile Duct NeoplasmNCT04906174
Effect of Materials for Subcuticular Suture (Quill vs. Monocryl) on Complications After Liver Resection
An observational study of Liver and Intrahepatic Bile Duct Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study investigates the effect of materials used in subcuticular suture on patients' outcomes after surgery. The prevention of surgical site wound infection is important to decrease the length of hospital stay and the post-operative risk of incisional hernia, especially in patients undergoing open hepatectomy… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver and Intrahepatic Bile Duct Neoplasm
- What is being tested?
- Electronic Health Record Review
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2021to 31 Dec 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 undergoing liver resection at MD Anderson Cancer Center from June 1, 2020 through January 31, 2021
Who may be able to join
- Patients >= 18 years of age undergoing liver resection at MD Anderson Cancer Center from June 1, 2020 through January 31, 2021
Who cannot join
- Patients who have a history of previous abdominal surgery will be excluded
- Pregnant women will not be included in this chart review
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Jean-Nicolas Vauthey, 713-792-6940, jvauthey@mdanderson.org
Jean-Nicolas Vauthey
About this study
Official title: Effect of Materials for Subcuticular Suture (Quill® vs. Monocryl®) on Complications After Liver Resection
This study investigates the effect of materials used in subcuticular suture on patients' outcomes after surgery. The prevention of surgical site wound infection is important to decrease the length of hospital stay and the post-operative risk of incisional hernia, especially in patients undergoing open hepatectomy (surgical removal of the liver). The purpose of this study is to compare the impact of the use of Quill versus Monocryl for subcuticular suture on patients' outcomes after surgery.
Read the detailed description
PRIMARY OBJECTIVE:
- To investigate the impact of materials for subcuticular suture (Quill versus [vs.] Monocryl) on complications after liver resection.
OUTLINE:
Patients' medical records are reviewed retrospectively.
- Being tested
- Electronic Health Record Review
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Medical records are reviewed
| Study group | Role | What they receive |
|---|---|---|
| Observational (medical record review) | Patients' medical records are reviewed retrospectively. Receives: Other: Electronic Health Record Review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of complications after liver resection
The impact of materials for subcuticular suture (Quill versus Monocryl) on complications after liver resection will be evaluated.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start10 Apr 2021
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver and Intrahepatic Bile Duct NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Nicolas Vauthey, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04906174
- Sponsor's protocol ID
- 2021-0258
- Other IDs
- NCI-2021-03485, 2021-0258
- Status last verified
- Apr 2023
- First submitted
- 12 May 2021
- Last updated
- 12 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Materials for Subcuticular Suture (Quill® vs. Monocryl®) on Complications After Liver Resection
- ClinicalTrials.gov ID
- NCT04906174
- Acronym / sponsor ID
- 2021-0258
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 10 Apr 2021 (actual)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 28 May 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.
This study investigates the effect of materials used in subcuticular suture on patients' outcomes after surgery. The prevention of surgical site wound infection is important to decrease the length of hospital stay and the post-operative risk of incisional hernia, especially in patients undergoing open hepatectomy (surgical removal of the liver). The purpose of this study is to compare the impact of the use of Quill versus Monocryl for subcuticular suture on patients' outcomes after surgery.
Detailed description
PRIMARY OBJECTIVE:
- To investigate the impact of materials for subcuticular suture (Quill versus [vs.] Monocryl) on complications after liver resection.
OUTLINE:
Patients' medical records are reviewed retrospectively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (medical record review) | – | Other: Electronic Health Record ReviewPatients' medical records are reviewed retrospectively. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing liver resection at MD Anderson Cancer Center from June 1, 2020 through January 31, 2021
Key inclusion criteria (1 listed)
- Patients >= 18 years of age undergoing liver resection at MD Anderson Cancer Center from June 1, 2020 through January 31, 2021
Key exclusion criteria (2 listed)
- Patients who have a history of previous abdominal surgery will be excluded
- Pregnant women will not be included in this chart review
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 |
|---|---|---|
| Electronic Health Record ReviewMedical records are reviewed | Other | Observational (medical record review) |
Primary outcome
Incidence of complications after liver resection
Time frame: 1 year
The impact of materials for subcuticular suture (Quill versus Monocryl) on complications after liver resection will be evaluated.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2023.
- MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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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.
Jean-Nicolas Vauthey principal investigator
M.D. Anderson Cancer Center
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 Liver and Intrahepatic Bile Duct Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
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 2 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 12 Apr 2023. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of complications after liver resection (time frame: 1 year). 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 12 Apr 2023.