Laparoscopic SurgeryNCT05145205
Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass
An observational study of Laparoscopic Surgery, run by Al-Azhar University at 1 site in Egypt.
Trial summary
This is a retrospective work on 200 morbid obese patients randomized and categorized into 2 groups according to the treatment method: the laparoscopic sleeve gastrectomy (LSG) and LRYGB groups, within the period from 2014 to 2019 and matched weight dissipation, complications, life quality, and negative events Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Laparoscopic Surgery
- What is being tested?
- Sleeve gastrectomy and Laparoscopic Roux-en-Y gastric bypass
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2020to 31 Dec 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 18 to 70 years
- All sexes
- Adult, Older adult
Study population: Study included Egyptian patients with age ranging from 18 to 70 seeking surgical operation for obesity.
Who may be able to join
- All patients of (Body Mass Index) more than 40, with at least 1 comorbidity
Who cannot join
- All patients of (Body Mass Index) less than 40,
- No comorbidities
- Patients who refused the surgical procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity
This is a retrospective work on 200 morbid obese patients randomized and categorized into 2 groups according to the treatment method: the laparoscopic sleeve gastrectomy (LSG) and LRYGB groups, within the period from 2014 to 2019 and matched weight dissipation, complications, life quality, and negative events
- Conditions
- Laparoscopic Surgery
- Being tested
- Sleeve gastrectomy, Laparoscopic Roux-en-Y gastric bypass
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sleeve gastrectomyProcedure or surgery
Bougie was applied over the lower curvature to adjust the gastric tube then longitudinal amputation of the stomach was performed for about 4 to 6 cm per pecker of the pylorus to the corner of His. No supportive materials were used, and over-suturing of the basic line performed only over the points of bleeding.
All resected specimens were sent to histopathology laboratory for examination.
Laparoscopic Roux-en-Y gastric bypassProcedure or surgery
An antecolic and antegastric RYGB become executed with a 150 cm alimentary limb with both a linearly or circularly kink (25 mm) gastrojejunostomy in step with the desire of the surgeon. A 50-cm-lengthy biliopancreati
| Study group | Role | What they receive |
|---|---|---|
| LSG | Not described Receives: Procedure: Sleeve gastrectomy | |
| RYGB | Not described Receives: Procedure: Laparoscopic Roux-en-Y gastric bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight dissipation
decrease the body mass index by 1 or more
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2021
- Study start1 Jan 2020
- Primary completion31 Dec 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdulkarim Hasan, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05145205
- Sponsor's protocol ID
- AUH210021
- Status last verified
- Nov 2021
- First submitted
- 23 Nov 2021
- Last updated
- 6 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass on Weight Loss in Patients With Morbid Obesity
- ClinicalTrials.gov ID
- NCT05145205
- Acronym / sponsor ID
- AUH210021
- Conditions
- Laparoscopic Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 6 Dec 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 is a retrospective work on 200 morbid obese patients randomized and categorized into 2 groups according to the treatment method: the laparoscopic sleeve gastrectomy (LSG) and LRYGB groups, within the period from 2014 to 2019 and matched weight dissipation, complications, life quality, and negative events
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LSG | – | Procedure: Sleeve gastrectomy |
| RYGB | – | Procedure: Laparoscopic Roux-en-Y gastric bypass |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Study included Egyptian patients with age ranging from 18 to 70 seeking surgical operation for obesity.
Key inclusion criteria (1 listed)
- All patients of (Body Mass Index) more than 40, with at least 1 comorbidity
Key exclusion criteria (3 listed)
- All patients of (Body Mass Index) less than 40,
- No comorbidities
- Patients who refused the surgical procedures.
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 |
|---|---|---|
| Sleeve gastrectomyBougie was applied over the lower curvature to adjust the gastric tube then longitudinal amputation of the stomach was performed for about 4 to 6 cm per pecker of the pylorus to the corner of His. No supportive materials were used, and over-suturing of the basic line performed only over the points of bleeding. All resected specimens were sent to histopathology laboratory for examination. | Procedure or surgery | LSG |
| Laparoscopic Roux-en-Y gastric bypassAn antecolic and antegastric RYGB become executed with a 150 cm alimentary limb with both a linearly or circularly kink (25 mm) gastrojejunostomy in step with the desire of the surgeon. A 50-cm-lengthy biliopancreati | Procedure or surgery | RYGB |
Primary outcome
weight dissipation
Time frame: 12 months
decrease the body mass index by 1 or more
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 6 Dec 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Laparoscopic Surgery, run by Al-Azhar 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 3 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 6 Dec 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 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?
weight dissipation (time frame: 12 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 6 Dec 2021.