Internal HerniasNCT01595230
Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
A study testing Closing the mesenteric defects with clips during opration in people with Internal Hernias, run by Region Zealand at 2 sites in Denmark.
Trial summary
The purpose of this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Internal Hernias
- What is being tested?
- Closing the mesenteric defects with clips during opration
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 405 participants
- Where
- 2 sitesDenmark
- Study dates
- May 2012to Jan 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who meet the requirements for a Gastric Bypass at Køge Hospital.
Who cannot join
- Patients who do not meet the inclusion criteria
- Patients who converted to open surgeon
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Department of Surgery;Bariatric Clinic, Køge Hospital
Køge, Sealand, 4600
Bariatric clinic, Department of Surgery, Køge hospital
Køge, 4600
About this study
Official title: Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
The purpose of this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias
- Conditions
- Internal Hernias
- Being tested
- Closing the mesenteric defects with clips during opration
- Keywords
- Internal Hernias, Clips, Gastric Bypass, Avoid
- Medical subject headings
- Internal Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closing the mesenteric defects with clips during oprationProcedure or surgery
Also called Clips, Herniestapler, Internal hernia, Gastric bypass
The laparoscopic Roux-en-Y gastric bypass surgery will be performed as usual. The patient will receive the closing of the mesenteric defects (the Petersen´s space and the entero-enterostomy site).The closing will happen at the end of the operation, using clips (herniestapler).
| Study group | Role | What they receive |
|---|---|---|
| Inertervention group_Clips to avoid internal herniation | Experimental | LRYGB with closure of the defects with simple hernia stapler clips. Aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass in order to avoid internal herniation. Receives: Procedure: Closing the mesenteric defects with clips during opration |
| Control group | No intervention | conventional LRYGB without closure of the mesenteric defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
To avoid the risk of Internal Hernias in patient with a Gastric bypass
Measured: 5 year
Secondary outcomes (2)
Postoperative pain score (VAS)
Measured: 5 years
Operative time consumption, the amount of clips, trocar and sutures used
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2012 (estimated)
- Study startMay 2012
- Primary completionJan 2023 (estimated)
- Study completionJan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Internal HerniasStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 405 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Zealand
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Kristensen, Region Zealand
- Investigators
- Sara Kristensen, Doctor, Principal investigator, Department of Surgery, Bariatric Clinic, Koge Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01595230
- Sponsor's protocol ID
- SJ-284
- Status last verified
- Mar 2020
- First submitted
- 9 May 2012
- Last updated
- 1 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Kristensen SD, Gormsen J, Naver L, Helgstrand F, Floyd AK. Randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery. Br J Surg. 2021 Mar 12;108(2):145-151. doi: 10.1093/bjs/znaa055.
PubMed 33711136Kristensen SD, Naver L, Jess P, Floyd AK. Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia. Dan Med J. 2014 Jun;61(6):A4854.
PubMed 24947625
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial: Internal Hernias After Gastric Bypass Can be Prevented Safely With Primary Closure of All Mesenteric Defects With Clips
- ClinicalTrials.gov ID
- NCT01595230
- Acronym / sponsor ID
- SJ-284
- Conditions
- Internal Hernias
- Keywords
- Internal Hernias, Clips, Gastric Bypass, Avoid
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 405 participants (actual)
- Lead sponsor
- Region ZealandUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jan 2023 (estimated)
- First posted
- 10 May 2012 (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 this study is to determine whether closure of all mesenteric defects with clips at the time of Gastric bypass, can avoid the complication of late bowel obstruction- internal hernias
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inertervention group_Clips to avoid internal herniation | Experimental | Procedure: Closing the mesenteric defects with clips during oprationLRYGB with closure of the defects with simple hernia stapler clips. Aim of this study is to evaluate the benefits and disadvantages of closing the mesenteric defects during gastric bypass in order to avoid internal herniation. |
| Control group | No intervention | –conventional LRYGB without closure of the mesenteric defects |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who meet the requirements for a Gastric Bypass at Køge Hospital.
Key exclusion criteria (2 listed)
- Patients who do not meet the inclusion criteria
- Patients who converted to open surgeon
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 |
|---|---|---|
| Closing the mesenteric defects with clips during oprationAlso: Clips, Herniestapler, Internal hernia, Gastric bypassThe laparoscopic Roux-en-Y gastric bypass surgery will be performed as usual. The patient will receive the closing of the mesenteric defects (the Petersen´s space and the entero-enterostomy site).The closing will happen at the end of the operation, using clips (herniestapler). | Procedure or surgery | Inertervention group_Clips to avoid internal herniation |
Primary outcome
To avoid the risk of Internal Hernias in patient with a Gastric bypass
Time frame: 5 year
2 secondary outcomes
Postoperative pain score (VAS)
Time frame: 5 years
Operative time consumption, the amount of clips, trocar and sutures used
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2020.
- Derived from this study: PubMed 33711136Kristensen SD, Gormsen J, Naver L, Helgstrand F, Floyd AK. Randomized clinical trial on closure versus non-closure of mesenteric defects during laparoscopic gastric bypass surgery. Br J Surg. 2021 Mar 12;108(2):145-151. doi: 10.1093/bjs/znaa055.
- Derived from this study: PubMed 24947625Kristensen SD, Naver L, Jess P, Floyd AK. Effect of closure of the mesenteric defect during laparoscopic gastric bypass and prevention of internal hernia. Dan Med J. 2014 Jun;61(6):A4854.
Related trials for Internal Hernias
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Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
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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.
Sara Kristensen, Doctor principal investigator
Department of Surgery, Bariatric Clinic, Koge Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closing the mesenteric defects with clips during opration in people with Internal Hernias, run by Region Zealand at 2 sites 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 1 inclusion and 2 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 1 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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?
To avoid the risk of Internal Hernias in patient with a Gastric bypass (time frame: 5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01595230, which also lists 2 linked publications.
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 Apr 2020.