HerniaNCT00138957
Study of a New Laparoscopic Technique for Parastomal Hernia Repair With Mesh
A study testing Laparoscopic parastomal hernia repair with mesh in people with Hernia and Abdominal Hernia, run by University Hospital, Gentofte, Copenhagen.
Trial summary
The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia repair using an intraperitoneally placed Proceed mesh, looking at postoperative complications, recurrence rate and postoperative pain and quality of life. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hernia, Abdominal Hernia
- What is being tested?
- Laparoscopic parastomal hernia repair with mesh
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Sep 2005to Dec 2007
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 80 years
- Indication for laparoscopic parastomal hernia repair in general anaesthesia.
- Danish speaking
- ASA group I-III
- No remaining malignancy after former primary radical operation for colorectal cancer
Who cannot join
- Former operation (open/lap) for parastomal hernia with insertion of mesh, or other mesh operation in the area of herniation
- Incarcerated hernia (acute operation)
- History of abuse or permanent morphine use
- Expected bad compliance
- Current systemic steroid use or other immuno-suppressive treatment
- HIV-positive, pregnant or breast feeding
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- Medical conditions contraindicating general anaesthesia
- Simultaneous operation for other ventral, inguinal or umbilical hernia
- Epidural or spinal anaesthesia
- Conversion to open procedure
About this study
Official title: Laparoscopic Parastomal Hernia Repair Using an Innovative Composite Polypropylene Mesh - A Prospective Study
The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia repair using an intraperitoneally placed Proceed mesh, looking at postoperative complications, recurrence rate and postoperative pain and quality of life.
Read the detailed description
Parastomal hernia affects up to 50% of all patients following formation of a stoma, most often in patients with a colostomy. About 20% of the patients need surgical correction of their parastomal hernia. Symptoms associated with parastomal hernias goes from mild physical (pain) and cosmetic discomfort to life threatening conditions with obstruction, strangulation and perforation. Parastomal hernias have big socioeconomic consequences and remain a considerable clinical problem.
The surgical treatment of parastomal hernias is controversial. The best way to treat it is to restore the continuity of the intestine, but in permanent stomas, this is not an option. Many surgical techniques have been described when intervention is required, but the results are unacceptable. The traditional open techniques are local simple suturing of the fascia defect, stoma relocation, or repair with a prosthetic material either intraperitoneally or extraperitoneally (subfascial or onlay). Overall, the results of all methods are poor with high recurrence rates and high morbidity and mortality. Mesh repair has the lowest recurrence rate (0-39%) and stoma relocation and simple suture has reported recurrence rates on 0-76% and 46-100%, respectively. Laparoscopic repair of parastomal hernias with a prosthetic mesh inserted intraperitoneally is a new method described in a few small series. The results so far are encouraging, but the follow-up period is short.
Looking at the disappointing results from the traditional open techniques in the treatment of parastomal hernias together with the enormous success in laparoscopic ventral hernia repair and laparoscopy overall, we believe that laparoscopic parastomal hernia repair with mesh will be an effective treatment option in the future. Therefore, we find it interesting to investigate the technique in a prospective study
- Conditions
- Hernia, Abdominal Hernia
- Being tested
- Laparoscopic parastomal hernia repair with mesh
- Keywords
- Laparoscopic parastomal hernia repair, Intraperitoneally, Mesh, Quality of life, Postoperative pain, Recurrence
- Medical subject headings
- Hernia, Hernia, Abdominal, Pain, Postoperative, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic parastomal hernia repair with meshProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence of parastomal hernia after 6 months (ultrasound and clinical)
Postoperative pain (Visual Analog Scale, VAS 0-100, Verbal Rating Scale, VRS 0-3)
Stricture of stoma (Bougie, mm)
Quality of life (SF-36 and Ostomy Adjustment Scale (OAS))
General well-being (VAS 0-100)
Postoperative ileus/paralysis > 24 hours
Patient's satisfaction (VAS 0-100)
Bandage problems (VRS 0-3)
Secondary outcomes (1)
Medical and surgical complications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2005 (estimated)
- Study startSep 2005
- Study completionDec 2007 (estimated)
Why it stopped: too few patients included
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Ethicon, Inc.
- Investigators
- Jacob Rosenberg, Prof, MD, Principal investigator, Gentofte University Hospital, Dept. of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00138957
- Sponsor's protocol ID
- KA05102m
- Status last verified
- Jul 2008
- First submitted
- 29 Aug 2005
- Last updated
- 11 Jul 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Parastomal Hernia Repair Using an Innovative Composite Polypropylene Mesh - A Prospective Study
- ClinicalTrials.gov ID
- NCT00138957
- Acronym / sponsor ID
- KA05102m
- Conditions
- Hernia, Abdominal Hernia
- Keywords
- Laparoscopic parastomal hernia repair, Intraperitoneally, Mesh, Quality of life, Postoperative pain, Recurrence
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: too few patients included
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Collaborators
- Ethicon, Inc.
- Study start
- Sep 2005
- Study completion
- Dec 2007 (estimated)
- First posted
- 30 Aug 2005 (estimated)
- 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.
The purpose of the study is to evaluate a new laparoscopic technique for parastomal hernia repair using an intraperitoneally placed Proceed mesh, looking at postoperative complications, recurrence rate and postoperative pain and quality of life.
Detailed description
Parastomal hernia affects up to 50% of all patients following formation of a stoma, most often in patients with a colostomy. About 20% of the patients need surgical correction of their parastomal hernia. Symptoms associated with parastomal hernias goes from mild physical (pain) and cosmetic discomfort to life threatening conditions with obstruction, strangulation and perforation. Parastomal hernias have big socioeconomic consequences and remain a considerable clinical problem.
The surgical treatment of parastomal hernias is controversial. The best way to treat it is to restore the continuity of the intestine, but in permanent stomas, this is not an option. Many surgical techniques have been described when intervention is required, but the results are unacceptable. The traditional open techniques are local simple suturing of the fascia defect, stoma relocation, or repair with a prosthetic material either intraperitoneally or extraperitoneally (subfascial or onlay). Overall, the results of all methods are poor with high recurrence rates and high morbidity and mortality. Mesh repair has the lowest recurrence rate (0-39%) and stoma relocation and simple suture has reported recurrence rates on 0-76% and 46-100%, respectively. Laparoscopic repair of parastomal hernias with a prosthetic mesh inserted intraperitoneally is a new method described in a few small series. The results so far are encouraging, but the follow-up period is short.
Looking at the disappointing results from the traditional open techniques in the treatment of parastomal hernias together with the enormous success in laparoscopic ventral hernia repair and laparoscopy overall, we believe that laparoscopic parastomal hernia repair with mesh will be an effective treatment option in the future. Therefore, we find it interesting to investigate the technique in a prospective study
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18 - 80 years
- Indication for laparoscopic parastomal hernia repair in general anaesthesia.
- Danish speaking
- ASA group I-III
- No remaining malignancy after former primary radical operation for colorectal cancer
Key exclusion criteria (10 listed)
- Former operation (open/lap) for parastomal hernia with insertion of mesh, or other mesh operation in the area of herniation
- Incarcerated hernia (acute operation)
- History of abuse or permanent morphine use
- Expected bad compliance
- Current systemic steroid use or other immuno-suppressive treatment
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 |
|---|---|---|
| Laparoscopic parastomal hernia repair with mesh | Procedure or surgery | – |
Primary outcome
Recurrence of parastomal hernia after 6 months (ultrasound and clinical)
Postoperative pain (Visual Analog Scale, VAS 0-100, Verbal Rating Scale, VRS 0-3)
Stricture of stoma (Bougie, mm)
Quality of life (SF-36 and Ostomy Adjustment Scale (OAS))
General well-being (VAS 0-100)
Postoperative ileus/paralysis > 24 hours
Patient's satisfaction (VAS 0-100)
Bandage problems (VRS 0-3)
1 secondary outcome
Medical and surgical complications
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2008.
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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.
Jacob Rosenberg, Prof, MD principal investigator
Gentofte University Hospital, Dept. of Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic parastomal hernia repair with mesh in people with Hernia and Abdominal Hernia, run by University Hospital, Gentofte, Copenhagen.
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 5 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: withdrawn, as of the sponsor's last update on 11 Jul 2008. 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 was withdrawn before enrolling participants, so there are no results.
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 of parastomal hernia after 6 months (ultrasound and clinical). The study lists 8 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 11 Jul 2008.