Parastomal HerniaLAROPANCT04950140
Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
A study testing Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia and Laparoscopic Surgery for the Treatment of Parastomal Hernia in people with Parastomal Hernia and Oncology, run by Instituto do Cancer do Estado de São Paulo.
Trial summary
Prospective randomized prospective interventional study with 40 consecutive patients for whom surgical treatment for PH was indicated and who are in postoperative follow-up with the Oncology Surgery group of the Department of Digestive Tract Surgery and Coloproctology, Faculty of Medicine, University of São Paulo . Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Parastomal Hernia, Oncology
- What is being tested?
- Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia and Laparoscopic Surgery for the Treatment of Parastomal Hernia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- 24 Jul 2021to 24 Jul 2023
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with PH in permanent ostomy, aged between 18 and 75 years, undergoing surgery for cancer treatment at ICESP, with stable cancer disease (recurrence or metastasis without evolution) or in follow-up after treatment with curative intent, who have computed tomography with a diagnosis of HP, and who agree to participate in the study.
Who cannot join
- Patient with progressive cancer disease. Presence of disease that prevents the performance of videolaparoscopic surgical procedure such as severe heart failure, severe lung disease, etc. Clinical criteria according to the research team that may indicate the application of another specific technique that is not covered in this study.
Trial locations and contacts
No sites are listed yet.
About this study
Prospective randomized prospective interventional study with 40 consecutive patients for whom surgical treatment for PH was indicated and who are in postoperative follow-up with the Oncology Surgery group of the Department of Digestive Tract Surgery and Coloproctology, Faculty of Medicine, University of São Paulo .
The free and informed consent form will be applied to the patient by the researchers in two copies of equal content and after any doubts related to the research are resolved, the patient will sign the copies together with the researcher. At any time, the patient may opt out of the study. The contacts of the researchers and the institution will be fully available to the research subject to resolve doubts and for any eventuality that may occur.
- Conditions
- Parastomal Hernia, Oncology
- Being tested
- Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia, Laparoscopic Surgery for the Treatment of Parastomal Hernia
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal HerniaProcedure or surgery
Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
Laparoscopic Surgery for the Treatment of Parastomal HerniaProcedure or surgery
Laparoscopic Surgery for the Treatment of Parastomal Hernia in Cancer Patients
| Study group | Role | What they receive |
|---|---|---|
| Robot Assisted Laparoscopic | Experimental | Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient Receives: Procedure: Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia |
| Conventional Laparoscopic Surgery | Active comparator | Conventional Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient Receives: Procedure: Laparoscopic Surgery for the Treatment of Parastomal Hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
To study the return time of ostomy functioning of patients approached by laparoscopic assisted robot using the Sugarbaker technique using a semi-absorbable biosynthetic mesh.
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 posted6 Jul 2021
- Study start24 Jul 2021 (estimated)
- Primary completion24 Sep 2021 (estimated)
- Study completion24 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Parastomal HerniaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto do Cancer do Estado de São Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04950140
- Sponsor's protocol ID
- NP1465
- Acronym
- LAROPA
- Status last verified
- Jun 2021
- First submitted
- 25 Jun 2021
- Last updated
- 6 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Clinical Trial Comparing Conventional Laparoscopic Surgery and Robot-Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient
- ClinicalTrials.gov ID
- NCT04950140
- Acronym / sponsor ID
- LAROPA / NP1465
- Conditions
- Parastomal Hernia, Oncology
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Instituto do Cancer do Estado de São PauloUniversity, hospital or other
- Study start
- 24 Jul 2021 (estimated)
- Primary completion
- 24 Sep 2021 (estimated)
- Study completion
- 24 Jul 2023 (estimated)
- First posted
- 6 Jul 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.
Prospective randomized prospective interventional study with 40 consecutive patients for whom surgical treatment for PH was indicated and who are in postoperative follow-up with the Oncology Surgery group of the Department of Digestive Tract Surgery and Coloproctology, Faculty of Medicine, University of São Paulo .
The free and informed consent form will be applied to the patient by the researchers in two copies of equal content and after any doubts related to the research are resolved, the patient will sign the copies together with the researcher. At any time, the patient may opt out of the study. The contacts of the researchers and the institution will be fully available to the research subject to resolve doubts and for any eventuality that may occur.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robot Assisted Laparoscopic | Experimental | Procedure: Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal HerniaRobot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient |
| Conventional Laparoscopic Surgery | Active comparator | Procedure: Laparoscopic Surgery for the Treatment of Parastomal HerniaConventional Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with PH in permanent ostomy, aged between 18 and 75 years, undergoing surgery for cancer treatment at ICESP, with stable cancer disease (recurrence or metastasis without evolution) or in follow-up after treatment with curative intent, who have computed tomography with a diagnosis of HP, and who agree to participate in the study.
Key exclusion criteria (1 listed)
- Patient with progressive cancer disease. Presence of disease that prevents the performance of videolaparoscopic surgical procedure such as severe heart failure, severe lung disease, etc. Clinical criteria according to the research team that may indicate the application of another specific technique that is not covered in this study.
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 |
|---|---|---|
| Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal HerniaRobot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia of the Oncology Patient | Procedure or surgery | Robot Assisted Laparoscopic |
| Laparoscopic Surgery for the Treatment of Parastomal HerniaLaparoscopic Surgery for the Treatment of Parastomal Hernia in Cancer Patients | Procedure or surgery | Conventional Laparoscopic Surgery |
Primary outcome
To study the return time of ostomy functioning of patients approached by laparoscopic assisted robot using the Sugarbaker technique using a semi-absorbable biosynthetic mesh.
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2021.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Robot Assisted Laparoscopic Surgery for the Treatment of Parastomal Hernia and Laparoscopic Surgery for the Treatment of Parastomal Hernia in people with Parastomal Hernia and Oncology, run by Instituto do Cancer do Estado de São Paulo.
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: status not confirmed, as of the sponsor's last update on 6 Jul 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Abdalla (+551121892646, ricardo.abdalla@hc.fm.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To study the return time of ostomy functioning of patients approached by laparoscopic assisted robot using the Sugarbaker technique using a semi-absorbable biosynthetic mesh. (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 6 Jul 2021.