Obesity and Obesity-related Medical ConditionsNCT06599489
Management of Obese Patients With Gastroesophageal Reflux Disease .
A study testing surgery ..operation in people with Obesity and Obesity-related Medical Conditions, run by Hossam Mahmoud Ibrahim.
Trial summary
The aim of this study is to evaluate the efficacy Sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping for management of morbidly obese patients with concomitant reflux symptoms. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity and Obesity-related Medical Conditions
- What is being tested?
- surgery ..operation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2024to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-60 years.
- Both sexes.
- BMI ≥ 40 or ≥ 35 with co-morbidity.with reflux symptoms .
- Failure of non-surgical treatment.
- Patients with hiatus hernia .
- Absence of endocrinal or psychological disorders.
Show all 9Show fewer
- Failure of non surgical treatment
- Non sweat eaters
- Patients with no previous upper GIT surgeries
Who cannot join
- Presence of endocrinal or psychological disorders.
- Morbidly obese patients with no reflux symptoms
- sweat eaters
- Patients with barrett,s oesophagus ,
- Patient with bad general condition
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Ahmed mo abdallah contact
About this study
Official title: Sleeve Gastrectomy With Crural Repair With or Without Ligamentum Teres Wrapping in Obese Patients With Gastroesophageal Reflux Disease .Arandomized Controlled Trial
The aim of this study is to evaluate the efficacy Sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping for management of morbidly obese patients with concomitant reflux symptoms.
Read the detailed description
All patients underwent a preoperative work-up including history and physical examination, routine laboratory investigations, ECG, chest radiography, pulmonary function tests, abdominal ultrasonography, and barium swallow, upper GIT endos¬copy, 24 hours PH monitoring, nutritional, and psychiat¬ric evaluation. Further exams and/or consultations were performed when indicated. The study design was a pro¬spective randomized controlled study that received ap¬proval from the ethics committee in relevant hospitals. All the patients gave an informed written consent All patients had a written informed consent of the two types laparoscopic procedures of obesity, Prophylactic anticoagulant medications will be given to all patients in the form of subcutaneous Clexane 0.5 unit/Kg/24. An Intensive care unit (ICU) bed will be reserved for all patients the night of operation with the decision of transfer left to the postoperative recovery assessment.
According to the patient selection, all patients will be divided into two groups as follows:
Group (A): Patients will do Laparoscopic sleeve gastrectomy with crural repair. Under a general anesthesia, the patient was placed in the split-leg position with the surgeon standing between the legs and the assistant on the left-hand side of the pa¬tient. A veress needle was used to create the pneumoperi-toneum. Three 12-mm trocars were inserted in the upper abdomen (one on the right, two on the left side) and one 5-mm trocar was inserted laterally in the left-upper quad¬rant. Retractor was inserted through the subxyphoid 10 mm trocar site to re¬tract the liver (five to seven Trocars always used) The hiatal hernia sac containing the proximal stomach was reduced. Distal esophagus and gastroesophageal junction were mobilized by using a laparoscopic Harmon¬ic Scalpel (Ethicon Endo-Surgery Inc., Cincinnati, OH) to get a 4-cm tension-free intra-abdominal esophagus. Pos¬terior crural
- Being tested
- surgery ..operation
- Keywords
- obesity and reflux
- Medical subject headings
- Obesity, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgery ..operationProcedure or surgery
Also called sleeve gastrectomy and cruroplasty, ligamentum teres wrapping
sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping
| Study group | Role | What they receive |
|---|---|---|
| sleeve gastrectomy and cruroplasty | Other | Under a general anesthesia. Three 12-mm trocars were inserted in the upper abdomen and one 5-mm trocar was inserted laterally in the left-upper quad¬rant. Retractor was inserted through the subxyphoid 10 mm trocar site to re¬tract the liver (five to seven Trocars always used) . The hiatal hernia sac containing the proximal stomach was reduced. Distal esophagus and gastroesophageal junction were mobilized by using a laparoscopic Harmon¬ic Scalpelto get a 4-cm tension-free intra-abdominal esophagus. Pos¬terior crural repair was performed with three interrupt¬ed Receives: Procedure: surgery ..operation |
| sleeve gastrectomy and cruroplasty with ligamentum teres wrapping | Other | sleeve gastrectomy and cruroplasty with ligamentum teres wrapping for cardiopexy for morbidly obese patients with reflux symptomspatients will Laparoscopic sleeve gastrectomy with crural repair with ligamentum teres wrapping .the same as in group (A) in addition to ligamentum teres wrapping behind lower end of oesophagus and fixed to anterior wall of stomach with interrupted sutures .
The mean follow up period was eight months .clinical outcomes were also evaluated in term of GERD symptoms improvement or resolution .interruption of anti reflux medications and xray evidence of HH recurrence. Receives: Procedure: surgery ..operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight loss and improvement of BMI
BMI from above 35 kg/m2 to less,than 30. kg /m2to be less than 35 kg /m2
Measured: 6 momths
Reflux symptoms
Improvement of all symptoms of reflux disease
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 posted19 Sep 2024
- Study start1 Oct 2024 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity and Obesity-related Medical ConditionsStudies 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
- Model description
- operation surgical intervention
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hossam Mahmoud Ibrahim
- Sponsor type
- University, hospital or other
- Collaborators
- Assiut University
- Responsible party
- Sponsor-investigator, Hossam Mahmoud Ibrahim, Assiut University
- Investigators
- Assiut university, Study chair, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06599489
- Sponsor's protocol ID
- obesity and GERD
- Status last verified
- Sep 2024
- First submitted
- 30 Aug 2024
- Last updated
- 19 Sep 2024
- Results posted
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleeve Gastrectomy With Crural Repair With or Without Ligamentum Teres Wrapping in Obese Patients With Gastroesophageal Reflux Disease .Arandomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06599489
- Acronym / sponsor ID
- obesity and GERD
- Keywords
- obesity and reflux
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hossam Mahmoud IbrahimUniversity, hospital or other
- Collaborators
- Assiut University
- Study start
- 1 Oct 2024 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (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 aim of this study is to evaluate the efficacy Sleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping for management of morbidly obese patients with concomitant reflux symptoms.
Detailed description
All patients underwent a preoperative work-up including history and physical examination, routine laboratory investigations, ECG, chest radiography, pulmonary function tests, abdominal ultrasonography, and barium swallow, upper GIT endos¬copy, 24 hours PH monitoring, nutritional, and psychiat¬ric evaluation. Further exams and/or consultations were performed when indicated. The study design was a pro¬spective randomized controlled study that received ap¬proval from the ethics committee in relevant hospitals. All the patients gave an informed written consent All patients had a written informed consent of the two types laparoscopic procedures of obesity, Prophylactic anticoagulant medications will be given to all patients in the form of subcutaneous Clexane 0.5 unit/Kg/24. An Intensive care unit (ICU) bed will be reserved for all patients the night of operation with the decision of transfer left to the postoperative recovery assessment.
According to the patient selection, all patients will be divided into two groups as follows:
Group (A): Patients will do Laparoscopic sleeve gastrectomy with crural repair. Under a general anesthesia, the patient was placed in the split-leg position with the surgeon standing between the legs and the assistant on the left-hand side of the pa¬tient. A veress needle was used to create the pneumoperi-toneum. Three 12-mm trocars were inserted in the upper abdomen (one on the right, two on the left side) and one 5-mm trocar was inserted laterally in the left-upper quad¬rant. Retractor was inserted through the subxyphoid 10 mm trocar site to re¬tract the liver (five to seven Trocars always used) The hiatal hernia sac containing the proximal stomach was reduced. Distal esophagus and gastroesophageal junction were mobilized by using a laparoscopic Harmon¬ic Scalpel (Ethicon Endo-Surgery Inc., Cincinnati, OH) to get a 4-cm tension-free intra-abdominal esophagus. Pos¬terior crural
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- operation surgical intervention
| Arm | Type | Receives |
|---|---|---|
| sleeve gastrectomy and cruroplasty | Other | Procedure: surgery ..operationUnder a general anesthesia. Three 12-mm trocars were inserted in the upper abdomen and one 5-mm trocar was inserted laterally in the left-upper quad¬rant. Retractor was inserted through the subxyphoid 10 mm trocar site to re¬tract the liver (five to seven Trocars always used) . The hiatal hernia sac containing the proximal stomach was reduced. Distal esophagus and gastroesophageal junction were mobilized by using a laparoscopic Harmon¬ic Scalpelto get a 4-cm tension-free intra-abdominal esophagus. Pos¬terior crural repair was performed with three interrupt¬ed |
| sleeve gastrectomy and cruroplasty with ligamentum teres wrapping | Other | Procedure: surgery ..operationsleeve gastrectomy and cruroplasty with ligamentum teres wrapping for cardiopexy for morbidly obese patients with reflux symptomspatients will Laparoscopic sleeve gastrectomy with crural repair with ligamentum teres wrapping .the same as in group (A) in addition to ligamentum teres wrapping behind lower end of oesophagus and fixed to anterior wall of stomach with interrupted sutures . The mean follow up period was eight months .clinical outcomes were also evaluated in term of GERD symptoms improvement or resolution .interruption of anti reflux medications and xray evidence of HH recurrence. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Age 18-60 years.
- Both sexes.
- BMI ≥ 40 or ≥ 35 with co-morbidity.with reflux symptoms .
- Failure of non-surgical treatment.
- Patients with hiatus hernia .
Key exclusion criteria (5 listed)
- Presence of endocrinal or psychological disorders.
- Morbidly obese patients with no reflux symptoms
- sweat eaters
- Patients with barrett,s oesophagus ,
- Patient with bad general condition
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 |
|---|---|---|
| surgery ..operationAlso: sleeve gastrectomy and cruroplasty, ligamentum teres wrappingsleeve gastrectomy with cruroplasty with or without ligamentum teres wrapping | Procedure or surgery | sleeve gastrectomy and cruroplasty, sleeve gastrectomy and cruroplasty with ligamentum teres wrapping |
Primary outcome
Weight loss and improvement of BMI
Time frame: 6 momths
BMI from above 35 kg/m2 to less,than 30. kg /m2to be less than 35 kg /m2
Reflux symptoms
Time frame: 6 months
Improvement of all symptoms of reflux disease
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- 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.
Ahmed mo abdallah contact
Assiut university study chair
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing surgery ..operation in people with Obesity and Obesity-related Medical Conditions, run by Hossam Mahmoud Ibrahim.
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 9 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: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hossam Mahmoud Ibrahim (800-555-5555, Hh093579@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight loss and improvement of BMI (time frame: 6 momths). The study lists 2 primary outcomes in all. 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 19 Sep 2024.