Obesity, MorbidNCT07560787
Impact of Crural Repair and Gastropexy During Laparoscopic Sleeve Gastrectomy
A study testing Laparoscopic Sleeve Gastrectomy with Crural Repair and Gastropexy and Standard Laparoscopic Sleeve Gastrectomy in people with Obesity, Morbid and Gastroesophageal Reflux Disease, run by Van Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
This prospective, randomized comparative controlled study evaluated the impact of concomitant posterior crural repair and posterior gastropexy on postoperative reflux outcomes in patients undergoing laparoscopic sleeve gastrectomy (LSG). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity, Morbid, Gastroesophageal Reflux Disease
- What is being tested?
- Laparoscopic Sleeve Gastrectomy with Crural Repair and Gastropexy and Standard Laparoscopic 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 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2022to 31 Jul 2024
- 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
- Age between 18 and 65 years
- Diagnosis of severe obesity for at least five years, defined as body mass index (BMI) > 40 kg/m², or BMI > 35 kg/m² in the presence of obesity-related comorbidities
- Temporary or inadequate weight-loss response to a dietitian-supervised medical weight-management programme
- Absence of hiatal hernia on preoperative upper gastrointestinal endoscopy
- Willingness to participate and ability to provide written informed consent
Who cannot join
- Refusal to provide informed consent
- History of upper gastrointestinal surgery
- Presence of gastric ulcer, esophagitis, or hiatal hernia on preoperative upper gastrointestinal endoscopy
- Known allergy to any of the planned postoperative medications (proton pump inhibitors, H2-receptor antagonists, paracetamol, or tramadol)
- Known coagulopathy
- Peripheral vascular disease
- History of cerebrovascular accident
- Intraoperative conversion to a bariatric procedure other than laparoscopic sleeve gastrectomy (LSG)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Concomitant Crural Repair and Gastropexy on Gastroesophageal Reflux and Postoperative Outcomes During Laparoscopic Sleeve Gastrectomy
This prospective, randomized comparative controlled study evaluated the impact of concomitant posterior crural repair and posterior gastropexy on postoperative reflux outcomes in patients undergoing laparoscopic sleeve gastrectomy (LSG). The study was completed with a total of 50 patients, with 25 patients in each group. Participants were allocated to either the control group, which received standard LSG, or the study group, which underwent LSG combined with systematic hiatal dissection, posterior crural repair, and posterior gastropexy. No patient had evidence of hiatal hernia on preoperative upper gastrointestinal endoscopy. The primary endpoint was postoperative reflux symptom burden at one-year follow-up, assessed using the Frequency Scale for the Symptoms of GERD (F-Scale) and the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS). Secondary endpoints included operative time, postoperative complications, length of hospital stay, proton pump inhibitor use, postoperative weight loss, and concordance between preoperative endoscopy and intraoperative hiatal assessment.
Read the detailed description
Laparoscopic sleeve gastrectomy (LSG) is a highly effective and widely performed bariatric procedure; however, postoperative gastroesophageal reflux disease (GERD) remains a significant and challenging complication. The mechanisms underlying reflux post-LSG are multifactorial, including disruption of the gastroesophageal junction, decreased lower esophageal sphincter pressure, and intrathoracic migration of the gastric sleeve.
This prospective, randomized, comparative controlled study aims to evaluate the efficacy of incorporating systematic hiatal dissection, posterior crural repair, and posterior gastropexy into the standard LSG procedure to mitigate postoperative reflux. A total of 50 patients with severe obesity completed the study, with 25 patients in each of the following groups:
- Control Group (n=25): Underwent standard LSG.
- Study Group (n=25): Underwent standard LSG combined with systematic intraoperative hiatal dissection, posterior crural repair to approximate the crura, and posterior gastropexy by anchoring the gastric corpus to the prepancreatic fascia.
These additional steps aim to preserve normal gastric anatomy, maintain the anatomical position of the sleeve, and prevent intrathoracic migration. Patients were evaluated preoperatively and at a one-year postoperative follow-up. The primary outcome is the assessment of postoperative reflux symptom burden using two questionnaires: the Frequency Scale for the Symptoms of GERD (F-Scale) and the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS). Secondary outcomes include a comparison of operative time, 30-day postoperative complications, length of hospital stay, postoperative weight loss (%EWL and %TWL), and changes in proton pump inhibitor (PPI) use. Additionally, the study assesses the concordance between preoperative endoscopic findings and intraoperative hiatal assessments in the study group.
- Conditions
- Obesity, Morbid, Gastroesophageal Reflux Disease
- Being tested
- Laparoscopic Sleeve Gastrectomy with Crural Repair and Gastropexy, Standard Laparoscopic Sleeve Gastrectomy
- Keywords
- Laparoscopic sleeve gastrectomy, Gastropexy, Crural repair, Bariatric surgery, GERD
- Medical subject headings
- Obesity, Morbid, Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic Sleeve Gastrectomy with Crural Repair and GastropexyProcedure or surgery
Laparoscopic sleeve gastrectomy (LSG) with systematic hiatal dissection, posterior crural repair using two interrupted 2-0 polypropylene sutures, and posterior gastropexy anchoring the gastric corpus to the prepancreatic fascia at two points using 3-0 V-Loc sutures.
Standard Laparoscopic Sleeve GastrectomyProcedure or surgery
Standard laparoscopic sleeve gastrectomy without hiatal dissection, crural repair, or gastropexy.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Active comparator | Standard laparoscopic sleeve gastrectomy (LSG) without crural repair or gastropexy. Receives: Procedure: Standard Laparoscopic Sleeve Gastrectomy |
| Study Group | Experimental | Laparoscopic sleeve gastrectomy (LSG) combined with systematic hiatal dissection, posterior crural repair, and posterior gastropexy. Receives: Procedure: Laparoscopic Sleeve Gastrectomy with Crural Repair and Gastropexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS)
The Gastrointestinal Symptom Assessment Scale (GSAS) is a validated self-administered questionnaire that assesses the severity and frequency of upper gastrointestinal symptoms over the preceding week. Each item is rated on a 4-point Likert scale, and reflux, dyspepsia, and total domain scores are calculated as the mean of their respective items, yielding scores ranging from 0 to 3. Higher scores indicate a greater symptom burden and a worse outcome; lower scores indicate a better outcome. The outcome is the change in GSAS reflux, dyspepsia, and total scores from the preoperative baseline to one year postoperatively, calculated as (postoperative score - preoperative score). Negative change values indicate symptomatic improvement.
Measured: Baseline within 4 weeks before surgery and 12 months postoperatively
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Frequency Scale for the Symptoms of GERD (F-Scale)
The Frequency Scale for the Symptoms of GERD (F-Scale; also known as the FSSG) is a validated 12-item self-administered questionnaire that evaluates the frequency of gastroesophageal reflux disease symptoms. Each item is scored on a 5-point Likert scale ranging from 0 (never) to 4 (always). The instrument yields three scores: a reflux subscale score (7 items; range 0-28), a dyspepsia/dysmotility subscale score (5 items; range 0-20), and a total score (range 0-48). Higher scores indicate a greater symptom burden and a worse outcome; lower scores indicate a better outcome. The outcome is the change in F-Scale total, reflux subscale, and dyspepsia subscale scores from the preoperative baseline to one year postoperatively, calculated as (postoperative score - preoperative score). Negative change values indicate symptomatic improvement.
Measured: Baseline within 4 weeks before surgery and 12 months postoperatively
Secondary outcomes (6)
Operative Time
Total duration of the surgical procedure in minutes, compared between standard LSG and LSG with crural repair and gastropexy groups.
Measured: Day 1
Incidence of Postoperative Complications
The number of participants experiencing early postoperative complications
Measured: Up to 30 days postoperatively
Length of Hospital Stay (LOS)
The total number of days the patient remained in the hospital following surgery, measured from the day of surgery to the day of hospital discharge.
Measured: Up to 30 days postoperatively
Change in Regular Proton Pump Inhibitor (PPI) Use
The number of patients reporting regular use of PPI medication, comparing their preoperative status to their postoperative status.
Measured: Baseline within 4 weeks before surgery and 12 months postoperatively
Postoperative Weight Loss
The magnitude of weight reduction, evaluated by calculating the percent excess weight loss (%EWL) and percent total weight loss (%TWL) from baseline to 12 months postoperatively. Higher values indicate greater weight reduction.
Measured: Baseline within 4 weeks before surgery and 12 months postoperatively
Concordance of Hiatal Assessment
The percentage of agreement between the findings of the preoperative upper gastrointestinal endoscopy and the actual intraoperative assessment regarding the presence or absence of a hiatal hernia.
Measured: Preoperative endoscopy performed within 4 weeks before surgery, and intraoperative hiatal assessment on Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start1 Nov 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, MorbidStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Van Training and Research Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Berk Topaloğlu, Van Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560787
- Sponsor's protocol ID
- FSMEAH-KAEK-2022/119
- Status last verified
- Apr 2026
- First submitted
- 19 Apr 2026
- Last updated
- 1 May 2026
- 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 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Concomitant Crural Repair and Gastropexy on Gastroesophageal Reflux and Postoperative Outcomes During Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT07560787
- Acronym / sponsor ID
- FSMEAH-KAEK-2022/119
- Conditions
- Obesity, Morbid, Gastroesophageal Reflux Disease
- Keywords
- Laparoscopic sleeve gastrectomy, Gastropexy, Crural repair, Bariatric surgery, GERD
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Van Training and Research HospitalOther government
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 1 May 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 prospective, randomized comparative controlled study evaluated the impact of concomitant posterior crural repair and posterior gastropexy on postoperative reflux outcomes in patients undergoing laparoscopic sleeve gastrectomy (LSG). The study was completed with a total of 50 patients, with 25 patients in each group. Participants were allocated to either the control group, which received standard LSG, or the study group, which underwent LSG combined with systematic hiatal dissection, posterior crural repair, and posterior gastropexy. No patient had evidence of hiatal hernia on preoperative upper gastrointestinal endoscopy. The primary endpoint was postoperative reflux symptom burden at one-year follow-up, assessed using the Frequency Scale for the Symptoms of GERD (F-Scale) and the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS). Secondary endpoints included operative time, postoperative complications, length of hospital stay, proton pump inhibitor use, postoperative weight loss, and concordance between preoperative endoscopy and intraoperative hiatal assessment.
Detailed description
Laparoscopic sleeve gastrectomy (LSG) is a highly effective and widely performed bariatric procedure; however, postoperative gastroesophageal reflux disease (GERD) remains a significant and challenging complication. The mechanisms underlying reflux post-LSG are multifactorial, including disruption of the gastroesophageal junction, decreased lower esophageal sphincter pressure, and intrathoracic migration of the gastric sleeve.
This prospective, randomized, comparative controlled study aims to evaluate the efficacy of incorporating systematic hiatal dissection, posterior crural repair, and posterior gastropexy into the standard LSG procedure to mitigate postoperative reflux. A total of 50 patients with severe obesity completed the study, with 25 patients in each of the following groups:
- Control Group (n=25): Underwent standard LSG.
- Study Group (n=25): Underwent standard LSG combined with systematic intraoperative hiatal dissection, posterior crural repair to approximate the crura, and posterior gastropexy by anchoring the gastric corpus to the prepancreatic fascia.
These additional steps aim to preserve normal gastric anatomy, maintain the anatomical position of the sleeve, and prevent intrathoracic migration. Patients were evaluated preoperatively and at a one-year postoperative follow-up. The primary outcome is the assessment of postoperative reflux symptom burden using two questionnaires: the Frequency Scale for the Symptoms of GERD (F-Scale) and the Gastroesophageal Reflux Disease Symptom Assessment Scale (GSAS). Secondary outcomes include a comparison of operative time, 30-day postoperative complications, length of hospital stay, postoperative weight loss (%EWL and %TWL), and changes in proton pump inhibitor (PPI) use. Additionally, the study assesses the concordance between preoperative endoscopic findings and intraoperative hiatal assessments in the study group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Active comparator | Procedure: Standard Laparoscopic Sleeve GastrectomyStandard laparoscopic sleeve gastrectomy (LSG) without crural repair or gastropexy. |
| Study Group | Experimental | Procedure: Laparoscopic Sleeve Gastrectomy with Crural Repair and GastropexyLaparoscopic sleeve gastrectomy (LSG) combined with systematic hiatal dissection, posterior crural repair, and posterior gastropexy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 65 years
- Diagnosis of severe obesity for at least five years, defined as body mass index (BMI) > 40 kg/m², or BMI > 35 kg/m² in the presence of obesity-related comorbidities
- Temporary or inadequate weight-loss response to a dietitian-supervised medical weight-management programme
- Absence of hiatal hernia on preoperative upper gastrointestinal endoscopy
- Willingness to participate and ability to provide written informed consent
Key exclusion criteria (8 listed)
- Refusal to provide informed consent
- History of upper gastrointestinal surgery
- Presence of gastric ulcer, esophagitis, or hiatal hernia on preoperative upper gastrointestinal endoscopy
- Known allergy to any of the planned postoperative medications (proton pump inhibitors, H2-receptor antagonists, paracetamol, or tramadol)
- Known coagulopathy
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 Crural Repair and GastropexyLaparoscopic sleeve gastrectomy (LSG) with systematic hiatal dissection, posterior crural repair using two interrupted 2-0 polypropylene sutures, and posterior gastropexy anchoring the gastric corpus to the prepancreatic fascia at two points using 3-0 V-Loc sutures. | Procedure or surgery | Study Group |
| Standard Laparoscopic Sleeve GastrectomyStandard laparoscopic sleeve gastrectomy without hiatal dissection, crural repair, or gastropexy. | Procedure or surgery | Control Group |
Primary outcome
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS)
Time frame: Baseline within 4 weeks before surgery and 12 months postoperatively
The Gastrointestinal Symptom Assessment Scale (GSAS) is a validated self-administered questionnaire that assesses the severity and frequency of upper gastrointestinal symptoms over the preceding week. Each item is rated on a 4-point Likert scale, and reflux, dyspepsia, and total domain scores are calculated as the mean of their respective items, yielding scores ranging from 0 to 3. Higher scores indicate a greater symptom burden and a worse outcome; lower scores indicate a better outcome. The outcome is the change in GSAS reflux, dyspepsia, and total scores from the preoperative baseline to one year postoperatively, calculated as (postoperative score - preoperative score). Negative change values indicate symptomatic improvement.
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Frequency Scale for the Symptoms of GERD (F-Scale)
Time frame: Baseline within 4 weeks before surgery and 12 months postoperatively
The Frequency Scale for the Symptoms of GERD (F-Scale; also known as the FSSG) is a validated 12-item self-administered questionnaire that evaluates the frequency of gastroesophageal reflux disease symptoms. Each item is scored on a 5-point Likert scale ranging from 0 (never) to 4 (always). The instrument yields three scores: a reflux subscale score (7 items; range 0-28), a dyspepsia/dysmotility subscale score (5 items; range 0-20), and a total score (range 0-48). Higher scores indicate a greater symptom burden and a worse outcome; lower scores indicate a better outcome. The outcome is the change in F-Scale total, reflux subscale, and dyspepsia subscale scores from the preoperative baseline to one year postoperatively, calculated as (postoperative score - preoperative score). Negative change values indicate symptomatic improvement.
6 secondary outcomes
Operative Time
Time frame: Day 1
Incidence of Postoperative Complications
Time frame: Up to 30 days postoperatively
Length of Hospital Stay (LOS)
Time frame: Up to 30 days postoperatively
Change in Regular Proton Pump Inhibitor (PPI) Use
Time frame: Baseline within 4 weeks before surgery and 12 months postoperatively
Postoperative Weight Loss
Time frame: Baseline within 4 weeks before surgery and 12 months postoperatively
Concordance of Hiatal Assessment
Time frame: Preoperative endoscopy performed within 4 weeks before surgery, and intraoperative hiatal assessment on Day 1
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 1 May 2026.
- 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.
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 Crural Repair and Gastropexy and Standard Laparoscopic Sleeve Gastrectomy in people with Obesity, Morbid and Gastroesophageal Reflux Disease, run by Van Training and Research Hospital at 1 site in Turkey (Türkiye).
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 5 inclusion and 8 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 1 May 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 Turkey (Türkiye). 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?
Change in Gastroesophageal Reflux Symptom Burden Assessed by the Gastrointestinal Symptom Assessment Scale (GSAS) (time frame: Baseline within 4 weeks before surgery and 12 months 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 1 May 2026.