Parastomal HerniaNCT04187235
Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia
An observational study of Parastomal Hernia, run by Aalborg University Hospital at 1 site in Denmark.
Trial summary
This is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parastomal Hernia
- What is being tested?
- Laparascopic repair of parastomal hernia
- Type of treatment
- Surgery or procedure
- How many people
- 135 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 1997to 30 Dec 2015
- 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 with parastomal hernia referred to Aarhus University Hospital
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia: A Long Term Case-controlled Prospective Study of Consecutive Patients.
This is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair.
Read the detailed description
Objective: To compare the laparoscopic Keyhole repair with the modified Sugarbaker repair in a nonrandomised case-controlled prospective study of consecutive patients with parastomal hernia.
Summary Background Data: Two reviews of uncontrolled studies concluded that the Sugarbaker repair is superior to the Keyhole repair. The present study challenges the claim.
Methods: In two time periods 135 patients with a parastomal hernia were repaired with the Keyhole technique (74 patients, using a two-layer mesh of polypropylene and ePTFE with a self-cut slit, 1997- 2009) or the Sugarbaker technique (61 patients, using a coated polypropylene mesh, 2009-2015). The patients in the two groups matched with regard to age, gender, ASA score, colostomy or ileostomy hernia, previous repairs, size of fascial defect and simultaneous repair of a concurrent incisional hernia. Observation time was defined as time to recurrence, stoma re-siting, mesh removal, death, or last non-event visit
- Conditions
- Parastomal Hernia
- Being tested
- Laparascopic repair of parastomal hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparascopic repair of parastomal herniaProcedure or surgery
Laparascopic repair of parastomal hernia
| Study group | Role | What they receive |
|---|---|---|
| Keyhole rapair | 74 patients who undervent parastomal hernia repair with keyhole technique 1997-2009 Receives: Procedure: Laparascopic repair of parastomal hernia | |
| Sugarbaker repair | 61 patients who undervent parastomal henia repair a.m. Sugarbaker 2009-2015 Receives: Procedure: Laparascopic repair of parastomal hernia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence
Recurrence of parastomal hernia
Measured: 3 years
Secondary outcomes (2)
Mesh-related morbidity
Late mesh-related morbidity
Measured: 3 years
Postoperative complications
Early postoperative complication
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2019
- Study start1 Jan 1997
- Primary completion30 Dec 2015
- Study completion30 Dec 2015
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.
- More trials run by Aalborg University 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vitaly Alexandrovich Gameza, Aalborg University Hospital
- Investigators
- Paul Wara, DMSc, Study chair, Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04187235
- Sponsor's protocol ID
- Keyhole vs Sugarbaker
- Status last verified
- Dec 2019
- First submitted
- 3 Dec 2019
- Last updated
- 5 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have no permission to share individual participant data with 3rd parties
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparascopic Keyhole vs Sugarbaker Repair in Parastomal Hernia: A Long Term Case-controlled Prospective Study of Consecutive Patients.
- ClinicalTrials.gov ID
- NCT04187235
- Acronym / sponsor ID
- Keyhole vs Sugarbaker
- Conditions
- Parastomal Hernia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Study start
- 1 Jan 1997 (actual)
- Primary completion
- 30 Dec 2015 (actual)
- Study completion
- 30 Dec 2015 (actual)
- First posted
- 5 Dec 2019 (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 is a non-randomised case-controlled prospective study of consecutive patients with parastomal hernia, comparing the laparoscopic Keyhole repair with the modified Sugarbaker repair.
Detailed description
Objective: To compare the laparoscopic Keyhole repair with the modified Sugarbaker repair in a nonrandomised case-controlled prospective study of consecutive patients with parastomal hernia.
Summary Background Data: Two reviews of uncontrolled studies concluded that the Sugarbaker repair is superior to the Keyhole repair. The present study challenges the claim.
Methods: In two time periods 135 patients with a parastomal hernia were repaired with the Keyhole technique (74 patients, using a two-layer mesh of polypropylene and ePTFE with a self-cut slit, 1997- 2009) or the Sugarbaker technique (61 patients, using a coated polypropylene mesh, 2009-2015). The patients in the two groups matched with regard to age, gender, ASA score, colostomy or ileostomy hernia, previous repairs, size of fascial defect and simultaneous repair of a concurrent incisional hernia. Observation time was defined as time to recurrence, stoma re-siting, mesh removal, death, or last non-event visit
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Keyhole rapair | – | Procedure: Laparascopic repair of parastomal hernia74 patients who undervent parastomal hernia repair with keyhole technique 1997-2009 |
| Sugarbaker repair | – | Procedure: Laparascopic repair of parastomal hernia61 patients who undervent parastomal henia repair a.m. Sugarbaker 2009-2015 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with parastomal hernia referred to Aarhus University Hospital
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Laparascopic repair of parastomal herniaLaparascopic repair of parastomal hernia | Procedure or surgery | Keyhole rapair, Sugarbaker repair |
Primary outcome
Recurrence
Time frame: 3 years
Recurrence of parastomal hernia
2 secondary outcomes
Mesh-related morbidity
Time frame: 3 years
Postoperative complications
Time frame: 30 days after 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 5 Dec 2019.
- Individual participant dataSharing planned: No. We have no permission to share individual participant data with 3rd parties
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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.
Paul Wara, DMSc study chair
Aarhus University Hospital
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 Parastomal Hernia, run by Aalborg University Hospital at 1 site in Denmark.
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 0 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 5 Dec 2019. 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 Denmark. 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?
Recurrence (time frame: 3 years). 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 5 Dec 2019.