Bariatric SurgeryNCT04788199
Novel Technique in Closure of Mesenteric Defects After Laparoscopic Roux-en-Y Gastric Bypass and Its Effect on Internal Hernia: a Case-control Study
An observational study of Bariatric Surgery, run by Mansoura University at 1 site in United Kingdom.
Trial summary
This study is to investigate the rate of internal hernia after laparoscopic Rox-en-Y gastric bypass when the defects are closed using cyano-acrylate glue. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bariatric Surgery
- What is being tested?
- Closure of mesenteric defects using glue
- How many people
- 928 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Jun 2018to 31 Jan 2020
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients with morbid obesity who were qualified to receive LRYGB in the period between September 2007 and January 2020
Who may be able to join
- All patients who underwent antecolic LRYGB without closure of mesenteric defects using cyanoacrylate glue or without closure of the mesenteric defects.
Who cannot join
- Open RYGB, laparoscopic converted to open RYGB, laparoscopic retro-colic RYGB, laparoscopic ante-colic RYGB with closure of the defect using sutures or RYGB done for non-bariatric purposes e.g. idiopathic gastroparesis.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St. Mary's Hospital, Imperial College Healthcare NHS Trust
London
About this study
Official title: Analytical Study of Internal Hernia Following Laparoscopic Roux-eny Gastric Bypass
This study is to investigate the rate of internal hernia after laparoscopic Rox-en-Y gastric bypass when the defects are closed using cyano-acrylate glue.
Read the detailed description
Background Internal hernia complicated by bowel obstruction is a well-recognized complication of laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study aims to investigate the role of cyanoacrylate glue in the prevention of internal hernia (IH) after LRYGB and compare it with the open technique of managing mesenteric defects by leaving the mesentery intact without closure of mesenteric defects. Data from six UK hospitals have been involved in this study. Operations were done under the supervision of a single senior consultant surgeon of bariatric surgery.
Methods The prospectively collected data of 813 patients with morbid obesity who underwent LRYGB were retrospectively analyzed. Patients were subdivided into two groups: group I comprising 185 patients who had the mesenteric defects closed with cyanoacrylate glue and group II comprising 628 patients who were managed by the open technique of leaving the mesentery intact without closure of the mesenteric defects.
- Conditions
- Bariatric Surgery
- Being tested
- Closure of mesenteric defects using glue
- Keywords
- Bypass, Gastric; Obesity, Morbid; Glue. Internal hernia; Laparoscopy.
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closure of mesenteric defects using glueOther
Cyano-acrylate glue is a glue known to be used in surgery as tissue adhesive.
| Study group | Role | What they receive |
|---|---|---|
| Non-closure group | Group in which mesenteric defects were not closed after laparoscopic Roux-en-Y gastric bypass. | |
| Closure group | Group in which mesenteric defects were closed using cyano-acrylate glue after laparoscopic Roux-en-Y gastric bypass. Receives: Other: Closure of mesenteric defects using glue |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with internal hernia after Laparoscopic Roux-en-Y gastric bypass
Measured: September 2007 to January 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2021
- Study start15 Jun 2018
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bariatric SurgeryStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 928 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ghanem, Mansoura University
- Investigators
- Ahmed Ghanem, Principal investigator, Mansoura Faculty of Medicine, Imperial College Healthcare NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04788199
- Sponsor's protocol ID
- R / 17.11.105
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 9 Mar 2021
- 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 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analytical Study of Internal Hernia Following Laparoscopic Roux-eny Gastric Bypass
- ClinicalTrials.gov ID
- NCT04788199
- Acronym / sponsor ID
- R / 17.11.105
- Conditions
- Bariatric Surgery
- Keywords
- Bypass, Gastric; Obesity, Morbid; Glue. Internal hernia; Laparoscopy.
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 928 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jun 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (actual)
- First posted
- 9 Mar 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.
This study is to investigate the rate of internal hernia after laparoscopic Rox-en-Y gastric bypass when the defects are closed using cyano-acrylate glue.
Detailed description
Background Internal hernia complicated by bowel obstruction is a well-recognized complication of laparoscopic Roux-en-Y gastric bypass (LRYGB). The present study aims to investigate the role of cyanoacrylate glue in the prevention of internal hernia (IH) after LRYGB and compare it with the open technique of managing mesenteric defects by leaving the mesentery intact without closure of mesenteric defects. Data from six UK hospitals have been involved in this study. Operations were done under the supervision of a single senior consultant surgeon of bariatric surgery.
Methods The prospectively collected data of 813 patients with morbid obesity who underwent LRYGB were retrospectively analyzed. Patients were subdivided into two groups: group I comprising 185 patients who had the mesenteric defects closed with cyanoacrylate glue and group II comprising 628 patients who were managed by the open technique of leaving the mesentery intact without closure of the mesenteric defects.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-closure group | – | –Group in which mesenteric defects were not closed after laparoscopic Roux-en-Y gastric bypass. |
| Closure group | – | Other: Closure of mesenteric defects using glueGroup in which mesenteric defects were closed using cyano-acrylate glue after laparoscopic Roux-en-Y gastric bypass. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients with morbid obesity who were qualified to receive LRYGB in the period between September 2007 and January 2020
Key inclusion criteria (1 listed)
- All patients who underwent antecolic LRYGB without closure of mesenteric defects using cyanoacrylate glue or without closure of the mesenteric defects.
Key exclusion criteria (1 listed)
- Open RYGB, laparoscopic converted to open RYGB, laparoscopic retro-colic RYGB, laparoscopic ante-colic RYGB with closure of the defect using sutures or RYGB done for non-bariatric purposes e.g. idiopathic gastroparesis.
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 |
|---|---|---|
| Closure of mesenteric defects using glueCyano-acrylate glue is a glue known to be used in surgery as tissue adhesive. | Other | Closure group |
Primary outcome
Number of participants with internal hernia after Laparoscopic Roux-en-Y gastric bypass
Time frame: September 2007 to January 2020
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 9 Mar 2021.
- 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.
Ahmed Ghanem principal investigator
Mansoura Faculty of Medicine, Imperial College Healthcare NHS Trust
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 Bariatric Surgery, run by Mansoura University at 1 site in United Kingdom.
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 1 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 9 Mar 2021. 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 United Kingdom. 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?
Number of participants with internal hernia after Laparoscopic Roux-en-Y gastric bypass (time frame: September 2007 to January 2020). 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 9 Mar 2021.