The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure.NCT01137201
Internal Hernia After Laparoscopic Gastric Bypass
A study testing Suturing of mesenteric defects in people with The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure., run by Region Örebro County at 1 site in Sweden.
Trial summary
To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure.
- What is being tested?
- Suturing of mesenteric defects
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,507 participants
- Where
- 1 siteSweden
- Study dates
- May 2010to Nov 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Any patient accepted for a Laparoscopic Gastric Bypass that has given a written consent
Who cannot join
- Conversion to open surgery prior to the randomization
- Patients not giving a written consent
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Department of Surgery, Örebro University Hospital
Örebro, Örebro County, 701 85
About this study
To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.
Read the detailed description
When the patients who has undergone a Laparoscopic Gastric Bypass lose weight, the mesenteric defects that are inevitable to cause, gets bigger and can cause an internal hernia (IH). This study will observe whether it is better to close the defects or leave them open. The patients will be randomized into two groups. One, where the defects are closed with sutures and one where the defects are left alone. The primary endpoint of the study is the prevalence of surgery for obstruction. Information about this will be gathered through the national register for obesity surgery in Sweden, SOReg. Each arm in the study will include 1200 patients and the follow up period will be three years. Since the register mentioned above is an ongoing register, the results can be studied over a longer period if wanted. The national hospital registry will further improve the follow-up.
- Being tested
- Suturing of mesenteric defects
- Keywords
- Small bowel obstruction, Laparoscopic gastric bypass, Internal Hernia, Mesenteric defect, Morbid obesity
- Medical subject headings
- Internal Hernia, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Suturing of mesenteric defectsProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Mesenteric defects sutured | Experimental | Closure of the mesenteric defects using running, non-absorbable suture Receives: Procedure: Suturing of mesenteric defects |
| Mesenteric defects not sutured | No intervention | Non-closure of the mesenteric defects |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgery for small bowel obstruction after a LGBP procedure.
Measured: 2 years
Secondary outcomes (1)
Serious Complications
Defined as Clavien grade 3b or more
Measured: within 2 years after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2010 (estimated)
- Study startMay 2010
- Primary completionDec 2013
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure.Studies 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
- None (open label)
- Enrolment
- 2,507 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Erik Stenberg, MD, Region Örebro County
- Investigators
- Ingmar Näslund, MD, PhD, Study director, Scandinavian Obesity Surgery Registry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01137201
- Sponsor's protocol ID
- EPN 2009/415
- Status last verified
- Dec 2015
- First submitted
- 2 Jun 2010
- Last updated
- 3 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Stenberg E, Ottosson J, Magnuson A, Szabo E, Wallen S, Naslund E, Thorell A, Naslund I. Long-term Safety and Efficacy of Closure of Mesenteric Defects in Laparoscopic Gastric Bypass Surgery: A Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):709-717. doi: 10.1001/jamasurg.2023.1042.
PubMed 37163240Stenberg E, Szabo E, Ottosson J, Thorell A, Naslund I. Health-Related Quality-of-Life after Laparoscopic Gastric Bypass Surgery with or Without Closure of the Mesenteric Defects: a Post-hoc Analysis of Data from a Randomized Clinical Trial. Obes Surg. 2018 Jan;28(1):31-36. doi: 10.1007/s11695-017-2798-z.
PubMed 28676957Stenberg E, Szabo E, Agren G, Ottosson J, Marsk R, Lonroth H, Boman L, Magnuson A, Thorell A, Naslund I. Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial. Lancet. 2016 Apr 2;387(10026):1397-1404. doi: 10.1016/S0140-6736(15)01126-5. Epub 2016 Feb 16.
PubMed 26895675
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Hernia After Laparoscopic Gastric Bypass
- ClinicalTrials.gov ID
- NCT01137201
- Acronym / sponsor ID
- EPN 2009/415
- Keywords
- Small bowel obstruction, Laparoscopic gastric bypass, Internal Hernia, Mesenteric defect, Morbid obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,507 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 4 Jun 2010 (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.
To see if closing the mesenteric defects created at a Laparoscopic Gastric Bypass is better than leaving them open.
Detailed description
When the patients who has undergone a Laparoscopic Gastric Bypass lose weight, the mesenteric defects that are inevitable to cause, gets bigger and can cause an internal hernia (IH). This study will observe whether it is better to close the defects or leave them open. The patients will be randomized into two groups. One, where the defects are closed with sutures and one where the defects are left alone. The primary endpoint of the study is the prevalence of surgery for obstruction. Information about this will be gathered through the national register for obesity surgery in Sweden, SOReg. Each arm in the study will include 1200 patients and the follow up period will be three years. Since the register mentioned above is an ongoing register, the results can be studied over a longer period if wanted. The national hospital registry will further improve the follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenteric defects sutured | Experimental | Procedure: Suturing of mesenteric defectsClosure of the mesenteric defects using running, non-absorbable suture |
| Mesenteric defects not sutured | No intervention | –Non-closure of the mesenteric defects |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient accepted for a Laparoscopic Gastric Bypass that has given a written consent
Key exclusion criteria (2 listed)
- Conversion to open surgery prior to the randomization
- Patients not giving a written consent
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 |
|---|---|---|
| Suturing of mesenteric defects | Procedure or surgery | Mesenteric defects sutured |
Primary outcome
Surgery for small bowel obstruction after a LGBP procedure.
Time frame: 2 years
1 secondary outcome
Serious Complications
Time frame: within 2 years 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 3 Dec 2015.
- Derived from this study: PubMed 37163240Stenberg E, Ottosson J, Magnuson A, Szabo E, Wallen S, Naslund E, Thorell A, Naslund I. Long-term Safety and Efficacy of Closure of Mesenteric Defects in Laparoscopic Gastric Bypass Surgery: A Randomized Clinical Trial. JAMA Surg. 2023 Jul 1;158(7):709-717. doi: 10.1001/jamasurg.2023.1042.
- Derived from this study: PubMed 28676957Stenberg E, Szabo E, Ottosson J, Thorell A, Naslund I. Health-Related Quality-of-Life after Laparoscopic Gastric Bypass Surgery with or Without Closure of the Mesenteric Defects: a Post-hoc Analysis of Data from a Randomized Clinical Trial. Obes Surg. 2018 Jan;28(1):31-36. doi: 10.1007/s11695-017-2798-z.
- Derived from this study: PubMed 26895675Stenberg E, Szabo E, Agren G, Ottosson J, Marsk R, Lonroth H, Boman L, Magnuson A, Thorell A, Naslund I. Closure of mesenteric defects in laparoscopic gastric bypass: a multicentre, randomised, parallel, open-label trial. Lancet. 2016 Apr 2;387(10026):1397-1404. doi: 10.1016/S0140-6736(15)01126-5. Epub 2016 Feb 16.
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.
Ingmar Näslund, MD, PhD study director
Scandinavian Obesity Surgery Registry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Suturing of mesenteric defects in people with The Prevalence of Surgery for Small Bowel Obstruction After LGBP Procedure., run by Region Örebro County at 1 site in Sweden.
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: finished, as of the sponsor's last update on 3 Dec 2015. 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 Sweden. 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?
Surgery for small bowel obstruction after a LGBP procedure. (time frame: 2 years). 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 NCT01137201, which also lists 3 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 3 Dec 2015.