Strangulated HerniaNCT01411397
Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection
A study testing SURGERY and mesh repair in people with Strangulated Hernia, run by Mansoura University at 1 site in Egypt.
Trial summary
Primary suture repair increases the risk for recurrence, the fact of benefit of mesh repair in elective situations is documented, and many studies have reported beneficial outcomes of mesh hernioplasty in emergency situations. Still there is controversy of using such grafts in presence of intestinal resection. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Strangulated Hernia
- What is being tested?
- SURGERY and mesh repair
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 1 siteEgypt
- Study dates
- Jun 2005to Jan 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- strangulated hernias
Who cannot join
- above 75, under 18
- recurrent hernia
- peritonitis
- pure omentum contents ASA above 3
Trial locations and contacts
1 site in 1 country.
About this study
Primary suture repair increases the risk for recurrence, the fact of benefit of mesh repair in elective situations is documented, and many studies have reported beneficial outcomes of mesh hernioplasty in emergency situations. Still there is controversy of using such grafts in presence of intestinal resection.
Read the detailed description
Patients with acutely incarcerated hernias (with small intestine contents) who underwent polypropylene mesh hernioplasty were included in this prospective study from June 2005 through Jan. 2011, patients were categorized into 2 groups who required intestinal resection anastomosis (group I)or not (group II).
- Conditions
- Strangulated Hernia
- Being tested
- SURGERY, mesh repair
- Keywords
- Infection, Prosthesis, Recurrence, Strangulation
- Medical subject headings
- Infections, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURGERYOther
Also called mesh hernioplasty
REPAIR OF STRANGULATED HERNIA with intestinal resection
mesh repairOther
Also called mesh hernioplasty without resection
mesh repair of strangulated hernia without resection
| Study group | Role | What they receive |
|---|---|---|
| mesh repair | Active comparator | MESH HERNIA REPAIR WHEN REqUIRE INTESTINAL RESECTION Receives: Other: SURGERY |
| mesh repair without intestinal resection | Active comparator | mesh repair of strangulated hernia without resection Receives: Other: mesh repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
wound infection
Measured: 5 weeks
Secondary outcomes (3)
operative time
the time from skin incision up to skin closure
Measured: 3hours
morbidity
the perioperative complications
Measured: 5 months
recurrence of the hernia
Recurrence of the hernia was defined as an apparent swelling or a palpable defect at the previous surgery site detected clinically or radiologically by ultrasound if needed
Measured: 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2011 (estimated)
- Study startJun 2005
- Primary completionJan 2011
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Strangulated HerniaStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Investigators
- ramadan ellithy, md, Study director, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01411397
- Sponsor's protocol ID
- strangulated hernia
- Status last verified
- Jun 2005
- First submitted
- 4 Aug 2011
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Hernioplasty Of Strangulated Hernias With Intestinal Resection
- ClinicalTrials.gov ID
- NCT01411397
- Acronym / sponsor ID
- strangulated hernia
- Conditions
- Strangulated Hernia
- Keywords
- Infection, Prosthesis, Recurrence, Strangulation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Jun 2005
- Primary completion
- Jan 2011 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 8 Aug 2011 (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.
Primary suture repair increases the risk for recurrence, the fact of benefit of mesh repair in elective situations is documented, and many studies have reported beneficial outcomes of mesh hernioplasty in emergency situations. Still there is controversy of using such grafts in presence of intestinal resection.
Detailed description
Patients with acutely incarcerated hernias (with small intestine contents) who underwent polypropylene mesh hernioplasty were included in this prospective study from June 2005 through Jan. 2011, patients were categorized into 2 groups who required intestinal resection anastomosis (group I)or not (group II).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesh repair | Active comparator | Other: SURGERYMESH HERNIA REPAIR WHEN REqUIRE INTESTINAL RESECTION |
| mesh repair without intestinal resection | Active comparator | Other: mesh repairmesh repair of strangulated hernia without resection |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- strangulated hernias
Key exclusion criteria (4 listed)
- above 75, under 18
- recurrent hernia
- peritonitis
- pure omentum contents ASA above 3
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 |
|---|---|---|
| SURGERYAlso: mesh hernioplastyREPAIR OF STRANGULATED HERNIA with intestinal resection | Other | mesh repair |
| mesh repairAlso: mesh hernioplasty without resectionmesh repair of strangulated hernia without resection | Other | mesh repair without intestinal resection |
Primary outcome
wound infection
Time frame: 5 weeks
3 secondary outcomes
operative time
Time frame: 3hours
morbidity
Time frame: 5 months
recurrence of the hernia
Time frame: 6months
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 8 Aug 2011.
Related trials for Strangulated Hernia
Not yet recruiting
Bassini Repair Versus Desarda Technique in Urgent Complicated Inguinal Hernia Repair
Inguinal Hernia, Incarcerated Inguinal Hernia
Not yet recruitingObservational study
Development of Taxi Teaching for Strangled Inguinal Hernias in Children
Pediatric Inguinal Hernia
Not yet recruitingObservational study
Outcomes of Different Surgical Procedures After High Level Resection for Patients With Small Intestinal Gangrene
Small Bowel Gangrene, Mesenteric Artery Ischemia
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.
ramadan ellithy, md study director
Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SURGERY and mesh repair in people with Strangulated Hernia, run by Mansoura University at 1 site in Egypt.
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 4 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 8 Aug 2011. 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 Egypt. 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?
wound infection (time frame: 5 weeks). 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 8 Aug 2011.