Morbid ObesityNCT03428386
Single-Anastomosis Plication Ileal Bypass for Morbid Obesity
A study testing Gastric plication ileal bypass in people with Morbid Obesity, run by Mansoura University at 1 site in Egypt.
Trial summary
The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Morbid Obesity
- What is being tested?
- Gastric plication ileal bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 30 May 2019
- 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 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Adult patients of both genders aging between 18 and 60 years with morbid obesity will be included to the study
Who cannot join
- Patients with secondary obesity due to endocrine disorders
- patient unfit for general anesthesia.
- patients who had not attempted non-surgical weight loss treatment in the past
- patients with psychological conditions that influence his/her perception of the study protocol
- patients with previous surgery for morbid obesity
Trial locations and contacts
1 site in 1 country.
Sameh H Emile contact
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university hospital
Al Mansurah, Dakahlia Governorate
Sameh Emile, M.D, sameh200@hotmail.com
Sameh H Emile, M.D.
About this study
Official title: Single-Anastomosis Plication Ileal Bypass in Treatment of Morbid Obesity: a Pilot Study
The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.
Read the detailed description
The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.
- Conditions
- Morbid Obesity
- Being tested
- Gastric plication ileal bypass
- Medical subject headings
- Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gastric plication ileal bypassProcedure or surgery
laparoscopic plication of the greater curvature of the stomach then the duodeno-jejunal junction is identified and 300 cm is measured downwards. The selected loop will be ascended without division of the greater omentum, and a stapled isoperistaltic side-to-side to the anterior wall of the antrum of the stomach just 3 cm away from the pylorus with a linear stapler charged with a green cartridge, the diameter of ileal antrum anastomosis is not exceeding 3 cm in diameter. The staple defect is closed with a two-layer running 3/0 polyglactin suture
| Study group | Role | What they receive |
|---|---|---|
| Gastric plication ileal bypass | Experimental | single-anastomosis plication ileal bypass Receives: Procedure: Gastric plication ileal bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Percentage of excess weight loss at 6 months after the procedure
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2018
- Study start1 Feb 2018
- Primary completion31 Jan 2019 (estimated)
- Study completion30 May 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Morbid ObesityStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Emile, Mansoura University
- Investigators
- Sameh H Emile, M.D., Principal investigator, Mansoura University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03428386
- Sponsor's protocol ID
- mansourau46
- Status last verified
- Feb 2018
- First submitted
- 4 Feb 2018
- Last updated
- 9 Feb 2018
- 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 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Anastomosis Plication Ileal Bypass in Treatment of Morbid Obesity: a Pilot Study
- ClinicalTrials.gov ID
- NCT03428386
- Acronym / sponsor ID
- mansourau46
- Conditions
- Morbid Obesity
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 9 Feb 2018 (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.
The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.
Detailed description
The present study aims to explore the impact of combining laparoscopic greater curvature plication with a single gastro-ileal anastomosis in the same manner of single anastomosis sleeve ileal bypass on weight loss and postoperative complications. The objective of this combined procedure is to reduce the high intraluminal pressure that results after laparoscopic greater curvature plication owing to reduced intraluminal space which can lead to suture line leakage, vomiting, and gastroesophageal reflux disease. Another objective is to add a malabsorptive element to the restrictive effect of laparoscopic greater curvature plication and to induce early satiety in patients by distention of the distal bowel with nutrients immediately after meals, similar to the way that single anastomosis sleeve ileal bypass works.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gastric plication ileal bypass | Experimental | Procedure: Gastric plication ileal bypasssingle-anastomosis plication ileal bypass |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Adult patients of both genders aging between 18 and 60 years with morbid obesity will be included to the study
Key exclusion criteria (5 listed)
- Patients with secondary obesity due to endocrine disorders
- patient unfit for general anesthesia.
- patients who had not attempted non-surgical weight loss treatment in the past
- patients with psychological conditions that influence his/her perception of the study protocol
- patients with previous surgery for morbid obesity
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 |
|---|---|---|
| Gastric plication ileal bypasslaparoscopic plication of the greater curvature of the stomach then the duodeno-jejunal junction is identified and 300 cm is measured downwards. The selected loop will be ascended without division of the greater omentum, and a stapled isoperistaltic side-to-side to the anterior wall of the antrum of the stomach just 3 cm away from the pylorus with a linear stapler charged with a green cartridge, the diameter of ileal antrum anastomosis is not exceeding 3 cm in diameter. The staple defect is closed with a two-layer running 3/0 polyglactin suture | Procedure or surgery | Gastric plication ileal bypass |
Primary outcome
weight loss
Time frame: 6 months
Percentage of excess weight loss at 6 months after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2018.
- 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.
Sameh H Emile contact
Sameh H Emile, M.D. principal investigator
Mansoura University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric plication ileal bypass in people with Morbid Obesity, 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 5 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 9 Feb 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sameh H Emile, M.D. (+201006267150, sameh200@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: 6 months). 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 Feb 2018.