Parastomal HerniaPHARAONCT04966065
Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomies
An observational study of Parastomal Hernia, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
Short Title: PHARAOH study: LAPAROSCOPIC PARASTOMAL HERNIA REPAIR WITH A NO HOLE MESH. Objectives: Evaluation of operative complications, colostomy function, Quality of Life and recurrence rate after laparoscopic repair of parastomal hernias in end-colostomies with a ParietexTM Parastomal No Hole mesh. 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?
- Parietex Parastomal mesh
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Mar 2016to 31 Dec 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 years and older
- All sexes
- Adult, Older adult
Study population: 100 adult patients, men or women, aged above 18, planned for primary elective laparoscopic hernia repair of an end-colostomy.
Who may be able to join
- adult patients, planned for primary elective laparoscopic hernia repair of an end-colostomy.
Who cannot join
- previous repair of a parastomal hernia at the same site
- emergency operations
- open parastomal hernia repair
- parastomal hernias at an ileostomy or an ileal conduit stoma
- loop colostomies
- patients under the age of 18 years
Show all 10Show fewer
- pregnant women
- ASA score 4 or more
- no informed consent of the patient
- patients unable to complete the stoma Quality of Life assessment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomieswith a Laparoscopic Modified Sugarbaker Technique in a Prospective Multicenter International Observational Study
Short Title: PHARAOH study: LAPAROSCOPIC PARASTOMAL HERNIA REPAIR WITH A NO HOLE MESH.
Objectives:
Read more
Evaluation of operative complications, colostomy function, Quality of Life and recurrence rate after laparoscopic repair of parastomal hernias in end-colostomies with a ParietexTM Parastomal No Hole mesh.
Principle Investigators:
Prof. Dr. Frederik Berrevoet, University Hospital Ghent Dr. Filip Muysoms, AZ Maria Middelares Ghent
Patient selection:
Adult consecutive patients, men or women, aged above 18, planned for primary elective laparoscopic hernia repair of an end-colostomy. A logbook will be kept of adult patients undergoing a parastomal hernia repair in the participating centers during the study period that are not entered in the study, including the reason for non inclusion. A total of 100 patients will be included during 24 months or until the sample size has been reached.
Exclusion criteria: previous repair of a parastomal hernia at the same site, emergency operations, open parastomal hernia repair, parastomal hernias at an ileostomy or an ileal conduit stoma, loop colostomies, patients under the age of 18 years, pregnant women, ASA score 4 or more, no informed consent of the patient, patients unable to complete the stoma Quality of Life assessment.
Primary Endpoint:
Evolution of Quality of Life with the Stoma-QoL score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively.
Secondary Endpoints:
Quality of Life of the patients with the EuraHS QoL score: preoperatively, at 1 month, 12 months and 24 month postoperatively. Recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. Intra-operative and post-operative complications, post-operative hospital stay, operation time.
Read the detailed description
Primary Endpoint:
Evolution of Quality of Life with the Stoma-QoL score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively.
Secondary Endpoints:
Quality of Life of the patients with the EuraHS QoL score: preoperatively, at 1 month, 12 months and 24 month postoperatively. Recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. Intra-operative and post-operative complications, post-operative hospital stay, operation time.
- Conditions
- Parastomal Hernia
- Being tested
- Parietex Parastomal mesh
- Keywords
- ostomy, hernia, parastomal, sugarbaker
- Medical subject headings
- Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parietex Parastomal meshDevice
Laparoscopic Modified Sugarbaker technique for repair of parastomal hernias in end-colostomies
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the QoL with the Stomy-QoL score assessment
Evaluation of the QoL with the Stomy-QoL score assessment of patients preop, at 1 month, 12 months and 24 months postoperatively
Measured: 24 months
Secondary outcomes (2)
Recurrence rate
Evaluation of the recurrence rates after surgical repair
Measured: 24 months
Peri-operative complications
All intra- and postoperative complications involving the surgical procedure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2021
- Study start14 Mar 2016
- Primary completion24 Sep 2018
- Study completion31 Dec 2018
Why it stopped: too slow patiënts recruitment
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 University Hospital, GhentThe 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Algemeen Ziekenhuis Maria Middelares, University of Wuerzburg, Universitaire Ziekenhuizen KU Leuven, Bispebjerg Hospital
- Responsible party
- Sponsor
- Investigators
- Frederik Berrevoet, MD, PhD, Principal investigator, University Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04966065
- Sponsor's protocol ID
- 2015_0164
- Acronym
- PHARAO
- Status last verified
- Aug 2023
- First submitted
- 7 Jul 2021
- Last updated
- 1 Sep 2023
- 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 1 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Parietex TM Parastomal No Hole Mesh for Repair of Parastomal Hernias in End-colostomieswith a Laparoscopic Modified Sugarbaker Technique in a Prospective Multicenter International Observational Study
- ClinicalTrials.gov ID
- NCT04966065
- Acronym / sponsor ID
- PHARAO / 2015_0164
- Conditions
- Parastomal Hernia
- Keywords
- ostomy, hernia, parastomal, sugarbaker
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: too slow patiënts recruitment
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Algemeen Ziekenhuis Maria Middelares, University of Wuerzburg, Universitaire Ziekenhuizen KU Leuven, Bispebjerg Hospital
- Study start
- 14 Mar 2016 (actual)
- Primary completion
- 24 Sep 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 19 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.
Short Title: PHARAOH study: LAPAROSCOPIC PARASTOMAL HERNIA REPAIR WITH A NO HOLE MESH.
Objectives:
Evaluation of operative complications, colostomy function, Quality of Life and recurrence rate after laparoscopic repair of parastomal hernias in end-colostomies with a ParietexTM Parastomal No Hole mesh.
Principle Investigators:
Prof. Dr. Frederik Berrevoet, University Hospital Ghent Dr. Filip Muysoms, AZ Maria Middelares Ghent
Patient selection:
Adult consecutive patients, men or women, aged above 18, planned for primary elective laparoscopic hernia repair of an end-colostomy. A logbook will be kept of adult patients undergoing a parastomal hernia repair in the participating centers during the study period that are not entered in the study, including the reason for non inclusion. A total of 100 patients will be included during 24 months or until the sample size has been reached.
Exclusion criteria: previous repair of a parastomal hernia at the same site, emergency operations, open parastomal hernia repair, parastomal hernias at an ileostomy or an ileal conduit stoma, loop colostomies, patients under the age of 18 years, pregnant women, ASA score 4 or more, no informed consent of the patient, patients unable to complete the stoma Quality of Life assessment.
Primary Endpoint:
Evolution of Quality of Life with the Stoma-QoL score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively.
Secondary Endpoints:
Quality of Life of the patients with the EuraHS QoL score: preoperatively, at 1 month, 12 months and 24 month postoperatively. Recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. Intra-operative and post-operative complications, post-operative hospital stay, operation time.
Detailed description
Primary Endpoint:
Evolution of Quality of Life with the Stoma-QoL score assessment of patients: preoperatively, at 1 month, 12 months and 24 months postoperatively.
Secondary Endpoints:
Quality of Life of the patients with the EuraHS QoL score: preoperatively, at 1 month, 12 months and 24 month postoperatively. Recurrence rate at 12 and at 24 months postoperatively evaluated by clinical examination and if available computer tomography. Intra-operative and post-operative complications, post-operative hospital stay, operation time.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- 100 adult patients, men or women, aged above 18, planned for primary elective laparoscopic hernia repair of an end-colostomy.
Key inclusion criteria (1 listed)
- adult patients, planned for primary elective laparoscopic hernia repair of an end-colostomy.
Key exclusion criteria (10 listed)
- previous repair of a parastomal hernia at the same site
- emergency operations
- open parastomal hernia repair
- parastomal hernias at an ileostomy or an ileal conduit stoma
- loop colostomies
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 |
|---|---|---|
| Parietex Parastomal meshLaparoscopic Modified Sugarbaker technique for repair of parastomal hernias in end-colostomies | Device | – |
Primary outcome
Evaluation of the QoL with the Stomy-QoL score assessment
Time frame: 24 months
Evaluation of the QoL with the Stomy-QoL score assessment of patients preop, at 1 month, 12 months and 24 months postoperatively
2 secondary outcomes
Recurrence rate
Time frame: 24 months
Peri-operative complications
Time frame: 6 months
Results and safety
The study was stopped early (reason given: too slow patiënts recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2023.
- 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.
Frederik Berrevoet, MD, PhD principal investigator
University Ghent
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 University Hospital, Ghent at 1 site in Belgium.
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 10 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: stopped early, as of the sponsor's last update on 1 Sep 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 Belgium. 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 was stopped early (reason given: too slow patiënts recruitment). Results are not available in the source record.
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?
Evaluation of the QoL with the Stomy-QoL score assessment (time frame: 24 months). 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 1 Sep 2023.