Obesity & OverweightGP-LSGNCT07861529
Effects of Posterior Gastropexy During Sleeve Gastrectomy on Quality of Life
A study testing Laparoscopic Sleeve Gastrectomy with Posterior Gastropexy and Standard Sleeve Gastrectomy in people with Obesity & Overweight, run by Helwan University at 1 site in Egypt.
Trial summary
This randomized controlled trial evaluates the clinical outcomes and quality of life in patients undergoing laparoscopic sleeve gastrectomy with or without posterior gastropexy. The primary objective is to assess the effectiveness of posterior gastropexy in reducing postoperative reflux and improving overall patient… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity & Overweight
- What is being tested?
- Laparoscopic Sleeve Gastrectomy with Posterior Gastropexy and Standard Sleeve Gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2023to 1 Apr 2025
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 to 65 years scheduled for elective laparoscopic sleeve gastrectomy.
- Body Mass Index (BMI) of 35 kg/m² or greater.
- Presence of preoperative symptoms or documentation of gastroesophageal reflux disease (GERD).
- Able to provide informed consent.
Who cannot join
- Previous history of bariatric or upper gastrointestinal surgery.
- Large hiatal hernia requiring formal repair.
- Contraindications to general anesthesia or laparoscopy.
- Pregnant or lactating females.Inclusion Criteria:
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Posterior Gastropexy During Laparoscopic Sleeve Gastrectomy on Gastrointestinal Quality of Life: A Pilot Randomized Controlled Trial
This randomized controlled trial evaluates the clinical outcomes and quality of life in patients undergoing laparoscopic sleeve gastrectomy with or without posterior gastropexy. The primary objective is to assess the effectiveness of posterior gastropexy in reducing postoperative reflux and improving overall patient satisfaction, with a 12-month follow-up period.
Read the detailed description
This study is designed as a pilot randomized controlled trial to investigate the role and clinical impact of adding posterior gastropexy to laparoscopic sleeve gastrectomy. Gastroesophageal reflux disease (GERD) is a frequent postoperative concern following sleeve gastrectomy; therefore, this trial aims to evaluate whether a posterior gastropexy technique can effectively mitigate postoperative reflux symptoms and enhance the patient's overall quality of life.
Eligible patients undergoing sleeve gastrectomy are randomly allocated into two groups: the study group receiving sleeve gastrectomy combined with posterior gastropexy, and the control group undergoing standard sleeve gastrectomy alone. Perioperative outcomes, intraoperative details, and postoperative complications are systematically documented. Patients are monitored through scheduled postoperative visits and standardized scoring questionnaires, including quality-of-life assessments (such as the GIQLI score), over a comprehensive 12-month follow-up period to assess both short- and medium-term clinical benefits.
- Conditions
- Obesity & Overweight
- Being tested
- Laparoscopic Sleeve Gastrectomy with Posterior Gastropexy, Standard Sleeve Gastrectomy
- Keywords
- obesity
- Medical subject headings
- Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve Gastrectomy with Posterior GastropexyProcedure or surgery
Laparoscopic sleeve gastrectomy combined with posterior gastropexy to assess clinical outcomes and GERD reduction.
Standard Sleeve GastrectomyProcedure or surgery
Standard laparoscopic sleeve gastrectomy procedure without posterior gastropexy.
| Study group | Role | What they receive |
|---|---|---|
| Sleeve Gastrectomy with Posterior Gastropexy | Experimental | Patients undergo laparoscopic sleeve gastrectomy combined with posterior gastropexy technique. Receives: Procedure: Laparoscopic Sleeve Gastrectomy with Posterior Gastropexy |
| Standard Sleeve Gastrectomy | Active comparator | Patients undergo standard laparoscopic sleeve gastrectomy alone without posterior gastropexy. Receives: Procedure: Standard Sleeve Gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastrointestinal Quality of Life
Assessment of the GIQLI total score based on 36 items covering physical, emotional, and social functioning, along with gastrointestinal symptoms, scored from 0 to 144.
Measured: At 6 months and 1 year postoperatively
Body Mass Index
Measurement of the patient body mass index expressed in kilograms per meter squared (kg/m²).
Measured: At 6 months and 1 year postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start1 Mar 2023
- Primary completion1 Apr 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Helwan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Baz, Helwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861529
- Sponsor's protocol ID
- HU-IRB: 25-2023
- Acronym
- GP-LSG
- Status last verified
- Oct 2026
- First submitted
- 25 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Yes, anonymized individual participant data will be made available upon reasonable request to the corresponding author.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Posterior Gastropexy During Laparoscopic Sleeve Gastrectomy on Gastrointestinal Quality of Life: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07861529
- Acronym / sponsor ID
- GP-LSG / HU-IRB: 25-2023
- Conditions
- Obesity & Overweight
- Keywords
- obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Helwan UniversityUniversity, hospital or other
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Apr 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 6 Oct 2026 (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 randomized controlled trial evaluates the clinical outcomes and quality of life in patients undergoing laparoscopic sleeve gastrectomy with or without posterior gastropexy. The primary objective is to assess the effectiveness of posterior gastropexy in reducing postoperative reflux and improving overall patient satisfaction, with a 12-month follow-up period.
Detailed description
This study is designed as a pilot randomized controlled trial to investigate the role and clinical impact of adding posterior gastropexy to laparoscopic sleeve gastrectomy. Gastroesophageal reflux disease (GERD) is a frequent postoperative concern following sleeve gastrectomy; therefore, this trial aims to evaluate whether a posterior gastropexy technique can effectively mitigate postoperative reflux symptoms and enhance the patient's overall quality of life.
Eligible patients undergoing sleeve gastrectomy are randomly allocated into two groups: the study group receiving sleeve gastrectomy combined with posterior gastropexy, and the control group undergoing standard sleeve gastrectomy alone. Perioperative outcomes, intraoperative details, and postoperative complications are systematically documented. Patients are monitored through scheduled postoperative visits and standardized scoring questionnaires, including quality-of-life assessments (such as the GIQLI score), over a comprehensive 12-month follow-up period to assess both short- and medium-term clinical benefits.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleeve Gastrectomy with Posterior Gastropexy | Experimental | Procedure: Laparoscopic Sleeve Gastrectomy with Posterior GastropexyPatients undergo laparoscopic sleeve gastrectomy combined with posterior gastropexy technique. |
| Standard Sleeve Gastrectomy | Active comparator | Procedure: Standard Sleeve GastrectomyPatients undergo standard laparoscopic sleeve gastrectomy alone without posterior gastropexy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients aged 18 to 65 years scheduled for elective laparoscopic sleeve gastrectomy.
- Body Mass Index (BMI) of 35 kg/m² or greater.
- Presence of preoperative symptoms or documentation of gastroesophageal reflux disease (GERD).
- Able to provide informed consent.
Key exclusion criteria (4 listed)
- Previous history of bariatric or upper gastrointestinal surgery.
- Large hiatal hernia requiring formal repair.
- Contraindications to general anesthesia or laparoscopy.
- Pregnant or lactating females.Inclusion Criteria:
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 |
|---|---|---|
| Laparoscopic Sleeve Gastrectomy with Posterior GastropexyLaparoscopic sleeve gastrectomy combined with posterior gastropexy to assess clinical outcomes and GERD reduction. | Procedure or surgery | Sleeve Gastrectomy with Posterior Gastropexy |
| Standard Sleeve GastrectomyStandard laparoscopic sleeve gastrectomy procedure without posterior gastropexy. | Procedure or surgery | Standard Sleeve Gastrectomy |
Primary outcome
Gastrointestinal Quality of Life
Time frame: At 6 months and 1 year postoperatively
Assessment of the GIQLI total score based on 36 items covering physical, emotional, and social functioning, along with gastrointestinal symptoms, scored from 0 to 144.
Body Mass Index
Time frame: At 6 months and 1 year postoperatively
Measurement of the patient body mass index expressed in kilograms per meter squared (kg/m²).
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 Oct 2026.
- Individual participant dataSharing planned: Yes. Yes, anonymized individual participant data will be made available upon reasonable request to the corresponding author.
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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?
A study testing Laparoscopic Sleeve Gastrectomy with Posterior Gastropexy and Standard Sleeve Gastrectomy in people with Obesity & Overweight, run by Helwan 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 4 inclusion and 4 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 Oct 2026. 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?
Gastrointestinal Quality of Life (time frame: At 6 months and 1 year postoperatively). 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 6 Oct 2026.