Gastro Esophageal RefluxSLEEVE-GERDNCT07158008
Comparison of Nissen-Sleeve and Gastric Bypass for GERD in Obese Patients
A study testing Nissen-Sleeve Gastrectomy (N-SG), Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) in people with Gastro Esophageal Reflux and Severe Obesity, run by Jagiellonian University at 1 site in Poland.
Trial summary
This randomized clinical trial aims to compare two surgical techniques for the treatment of obesity in patients who also have symptoms of gastroesophageal reflux disease (GERD). The study will compare Nissen-Sleeve Gastrectomy (N-SG)-a sleeve gastrectomy combined with a reflux-preventing procedure-to the Roux-en-Y… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gastro Esophageal Reflux, Severe Obesity, Bariatric Surgery
- What is being tested?
- Nissen-Sleeve Gastrectomy (N-SG), Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 560 participants
- Where
- 1 sitePoland
- Study dates
- 31 Jul 2025to Sep 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For N-Sleeve Gastrectomy (N-SG) and Roux-en-Y Gastric Bypass (RYGB) arms:
- Age ≥ 18 years
- Written informed consent provided
- Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with obesity-related comorbidities)
- Presence of symptomatic gastroesophageal reflux disease (GERD), defined by at least one of the following:
- Regular use of proton pump inhibitors (PPIs)
Show all 13Show fewer
- GerdQ score > 6
- Endoscopic evidence of esophagitis (Los Angeles classification grade B or higher)
- For Sleeve Gastrectomy (SG) observational control group:
- Age ≥ 18 years
- Written informed consent provided
- Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with obesity-related comorbidities)
- No symptoms or history of GERD
Who cannot join
- History of prior anti-reflux surgery
- History of upper gastrointestinal tract surgery
- Active smoking or history of nicotine use
- Severe cardiac insufficiency (New York Heart Association Class III or IV)
- Pregnancy or planned pregnancy during the study period (if applicable based on future additions)
- Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with the study protocol or would pose additional risk
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Szpital Uniwersytecki w Krakowie
Krakow, 30-688
Piotr Małczak, PhD, MD, 0048124002600, piotr.malczak@uj.edu.pl
About this study
Official title: The SLEEVE-GERD Trial: A Comparative Study of Nissen-Sleeve and Roux-en-Y Gastric Bypass in Obese Patients With GERD
This randomized clinical trial aims to compare two surgical techniques for the treatment of obesity in patients who also have symptoms of gastroesophageal reflux disease (GERD). The study will compare Nissen-Sleeve Gastrectomy (N-SG)-a sleeve gastrectomy combined with a reflux-preventing procedure-to the Roux-en-Y Gastric Bypass (RYGB), which is the current standard surgical option for obese patients with GERD.
Both procedures are widely used to treat severe obesity, but they differ in how they affect the digestive system and the potential for reflux control, nutritional outcomes, and future surgical options. N-SG is a newer technique that preserves the natural pathway of the gastrointestinal tract and allows standard endoscopic access to the bile ducts, which may be beneficial for long-term patient care. RYGB, on the other hand, bypasses part of the stomach and small intestine, which may lead to better reflux resolution but carries risks of nutritional deficiencies and altered anatomy.
Read more
Eligible participants with obesity and GERD symptoms will be randomly assigned to receive either N-SG or RYGB. The primary goal is to evaluate whether N-SG is not inferior to RYGB in reducing GERD symptoms one year after surgery. Secondary outcomes include weight loss, quality of life, surgical complications, and changes in the hormone ghrelin, which is involved in appetite regulation.
In addition, a larger control group of patients without GERD undergoing standard sleeve gastrectomy will be recruited to allow further comparisons. All participants will be followed for one year after surgery, with blood samples, questionnaires, and clinical data collected to assess both metabolic and reflux-related outcomes.
This study is being conducted at the University Hospital in Kraków, Poland, and aims to improve the personalization of bariatric treatment for patients suffering from both obesity and reflux.
Read the detailed description
This randomized clinical trial is designed to compare the safety and effectiveness of Nissen-Sleeve Gastrectomy (N-SG) versus Roux-en-Y Gastric Bypass (RYGB) in patients with obesity and symptoms of gastroesophageal reflux disease (GERD). N-SG is a modified sleeve gastrectomy procedure that incorporates an anti-reflux mechanism based on the Nissen fundoplication technique, while RYGB is a well-established bariatric procedure with proven anti-reflux efficacy.
Background and Rationale:
Severe obesity (BMI ≥ 40 or ≥ 35 with comorbidities) is a growing health problem and is frequently associated with GERD. While sleeve gastrectomy (SG) is currently the most widely performed bariatric procedure globally, it has been associated with the development or worsening of GERD in a significant number of cases. RYGB has become the standard surgical approach in obese patients with pre-existing GERD due to its high rate of reflux symptom resolution. However, RYGB involves more complex anatomical changes, carries a risk of nutritional deficiencies, and limits future endoscopic access to the biliary tract.
The Nissen-Sleeve Gastrectomy (N-SG), first described by David Nocca in 2016, combines SG with a 360-degree gastric fundoplication wrap (similar to that used in traditional Nissen fundoplication). This technique preserves gastrointestinal continuity and potentially maintains endoscopic access to the duodenum, while adding a reflux barrier. Early observational studies suggest favorable outcomes in terms of GERD resolution while retaining the benefits of SG. However, no large-scale randomized controlled trial has compared N-SG with RYGB in this specific patient population.
Study Design:
This is a prospective, single-center, randomized controlled non-inferiority trial conducted at the University Hospital in Kraków, Poland. Patients with obesity and clinically confirmed GERD will be randomized in a 1:1 ratio to receive either N-SG or RYGB. Randomization is performed using a computer-generated block randomization schedule. Allocation will be concealed in sealed envelopes and opened immediately prior to surgery. The estimated sample size for the randomized arms is 140 patients (70 per group), accounting for an assumed 15% dropout rate, and powered to detect non-inferiority with a margin of 10%.
In addition to the randomized comparison, a non-randomized observational control group of approximately 420 patients undergoing standard SG without GERD symptoms will be enrolled. This group will allow propensity-matched analyses and further comparisons of outcomes.
Surgical Techniques:
Nissen-Sleeve Gastrectomy (N-SG): The greater curvature of the stomach is mobilized, short gastric vessels are divided, and the fundus is used to create a posterior wrap around the distal esophagus. A 360-degree fundoplication (Nissen) is performed laparoscopically. This is followed by longitudinal gastric resection using a 40Fr bougie to calibrate the sleeve.
Roux-en-Y Gastric Bypass (RYGB): A small proximal gastric pouch is created. A 100 cm alimentary (Roux) limb is anastomosed to the pouch. A biliopancreatic limb of 150 cm is created via jejunojejunostomy, and the continuity of the gastrointestinal tract is restored. The stomach remnant and duodenum are excluded from the alimentary flow.
Follow-Up and Data Collection:
All patients will be followed for at least 12 months postoperatively. Clinical data will be collected at baseline, postoperatively, and at follow-up visits. Blood samples will be obtained at four time points: (1) day of surgery, (2) first postoperative day, (3) one week post-discharge (during suture removal), and (4) at 12-month follow-up. Blood will be analyzed for serum ghrelin levels using ELISA-based testing.
GERD symptoms will be assessed pre- and postoperatively using the validated GerdQ questionnaire. A score below 5 at 12 months, along with discontinuation of proton pump inhibitor (PPI) therapy for at least 60 days, will be considered remission of GERD.
Outcomes:
Primary outcome: GERD symptom resolution at 12 months post-op, comparing N-SG to RYGB.
Secondary outcomes: Weight loss (measured as %EWL, %TWL, and BMI change), serum ghrelin levels, incidence of postoperative complications (Clavien-Dindo scale), and quality of life metrics.
Control Group:
Patients without GERD undergoing standard SG will serve as an observational control cohort. This group will provide comparative data on weight loss and metabolic changes without the influence of pre-existing reflux disease. Their data will be used for secondary analyses and matched comparisons.
Ethical Considerations:
The study has received approval from the Bioethics Committee of Jagiellonian University Medical College. Written informed consent will be obtained from all participants. Participation is voluntary, and subjects may withdraw at any time. The N-SG technique is investigational in Poland and may only be offered within this trial framework. Patients declining randomization will receive the standard of care (RYGB or SG based on clinical indication).
Potential Risks and Complications:
Both RYGB and SG are well-established surgical procedures. N-SG may be associated with additional risks specific to fundoplication, such as cuff leak or stenosis. These complications will be managed with standard endoscopic or surgical protocols as needed. All participants will be closely monitored throughout the study.
This trial seeks to evaluate whether N-SG can offer equivalent reflux control to RYGB while avoiding the anatomical disruption and long-term risks associated with bypass surgery. The results may support broader adoption of N-SG as a tailored option for obese patients with GERD.
- Conditions
- Gastro Esophageal Reflux, Severe Obesity, Bariatric Surgery
- Being tested
- Nissen-Sleeve Gastrectomy (N-SG), Roux-en-Y Gastric Bypass (RYGB), Sleeve Gastrectomy (SG)
- Keywords
- Nissen-Sleeve, Gastric Bypass, GERD
- Medical subject headings
- Gastroesophageal Reflux, Obesity, Morbid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nissen-Sleeve Gastrectomy (N-SG)Procedure or surgery
Laparoscopic Nissen-Sleeve Gastrectomy is a modification of standard sleeve gastrectomy that incorporates an anti-reflux procedure. The greater curvature of the stomach is mobilized and short gastric vessels are divided. A segment of the gastric fundus is preserved and passed behind the distal esophagus to create a 360-degree wrap (Nissen fundoplication) around the lower esophageal sphincter. The crura of the diaphragm are approximated if necessary. Following fundoplication, the remainder of the stomach is resected longitudinally over a 40 French bougie using a linear stapling device, creating a tubular gastric conduit. This approach aims to achieve weight loss while providing a functional anti-reflux barrier and maintaining gastrointestinal continuity.
Roux-en-Y Gastric Bypass (RYGB)Procedure or surgery
Laparoscopic Roux-en-Y Gastric Bypass is a standard bariatric procedure that combines gastric restriction with intestinal bypass. A small proximal gastric pouch is created using linear staplers, completely separating it from the gastric remnant. A 100 cm alimentary (Roux) limb of jejunum is measured from the ligament of Treitz and anastomosed to the gastric pouch (gastrojejunostomy) using a linear stapler. A jejunojejunostomy is then performed 150 cm distal to the gastrojejunostomy to connect the biliopancreatic limb to the alimentary limb, restoring intestinal continuity. The mesenteric defects are closed to reduce the risk of internal hernia. This procedure promotes weight loss and has established effectiveness in reducing gastroesophageal reflux symptoms.
Sleeve Gastrectomy (SG)Procedure or surgery
Laparoscopic Sleeve Gastrectomy is a restrictive bariatric procedure involving longitudinal resection of the stomach to create a tubular gastric conduit. The greater curvature is mobilized and short gastric vessels are divided. Using a bougie as a guide, the stomach is divided with a linear stapling device from the antrum to the angle of His, removing approximately 75-80% of gastric volume, including most of the fundus. This reduces stomach capacity and ghrelin production, promoting weight loss while maintaining gastrointestinal continuity.
| Study group | Role | What they receive |
|---|---|---|
| Nissen-Sleeve Gastrectomy (N-SG) | Experimental | Participants in this arm will undergo laparoscopic sleeve gastrectomy combined with Nissen fundoplication. The procedure includes partial preservation of the gastric fundus to form a 360-degree wrap around the distal esophagus, followed by sleeve resection of the remaining stomach. This technique aims to provide both weight loss and reflux control while maintaining gastrointestinal continuity. Receives: Procedure: Nissen-Sleeve Gastrectomy (N-SG) |
| Roux-en-Y Gastric Bypass (RYGB) | Active comparator | Participants in this arm will undergo standard laparoscopic Roux-en-Y gastric bypass. The procedure includes the creation of a small gastric pouch, a 100 cm alimentary (Roux) limb, and a 150 cm biliopancreatic limb. The bypass alters the gastrointestinal anatomy to promote weight loss and has established effectiveness in reducing GERD symptoms. Receives: Procedure: Roux-en-Y Gastric Bypass (RYGB) |
| Sleeve Gastrectomy - Control (No GERD) | Other | This non-randomized observational group includes patients without GERD symptoms undergoing standard sleeve gastrectomy. Data from this group will be used for secondary matched analyses to evaluate weight loss and hormonal changes, serving as a control for comparative evaluation with the randomized arms. Receives: Procedure: Sleeve Gastrectomy (SG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
GERD Symptom Remission
Resolution of GERD symptoms, defined as:
No need for proton pump inhibitors (PPIs) for at least 60 consecutive days, and
GerdQ questionnaire score < 7 at 12-month follow-up. Comparison between Nissen-Sleeve Gastrectomy (N-SG) and Roux-en-Y Gastric Bypass (RYGB) arms.
Measured: 12 months post-surgery
Secondary outcomes (7)
Percent Excess Weight Loss (%EWL)
Percentage of excess weight loss, calculated based on initial excess body weight. Compared across all three study arms.
Measured: 12 months post-surgery
Percent Total Weight Loss (%TWL)
Percentage of total body weight loss from baseline. Compared across all three study arms.
Measured: 12 months post-surgery
Change in Body Mass Index (BMI)
12 months post-surgery
Measured: Difference in BMI from baseline to 12 months. Compared across all three study arms.
Change in Serum Ghrelin Levels
Change in fasting plasma ghrelin concentration measured by ELISA assay. Compared across N-SG, RYGB, and SG (control) arms.
Measured: Baseline (day of surgery), postoperative day 1, day 7 after discharge, and 12 months post-surgery
Postoperative Complication Rate (Clavien-Dindo Classification ≥ Grade III)
Number and percentage of serious postoperative complications classified as Clavien-Dindo grade III or higher.
Measured: Up to 30 days post-surgery
Quality of Life (QoL) Score
Quality of life assessed using validated tools (BAROS) Comparison between N-SG and RYGB arms.
Measured: 12 months post-surgery
GERD Related Quality of Life
Assesment of changes in quality of life associated with GERD using GERD-HRQL questionnaire comparing N-SG with RYGB before surgery and 12 months after
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2025
- Study start31 Jul 2025
- Primary completion31 Jul 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastro Esophageal RefluxStudies 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
- Participants with obesity and gastroesophageal reflux disease (GERD) symptoms are randomly assigned in a 1:1 ratio to undergo either Nissen-Sleeve Gastrectomy (N-SG) or Roux-en-Y Gastric Bypass (RYGB). Randomization is stratified and block-based, with allocation concealed using sealed envelopes. A third, non-randomized observational cohort of patients without GERD undergoing standard sleeve gastrectomy (SG) is included to allow matched secondary analyses. The primary comparison is between the two randomized arms (N-SG vs. RYGB).
- Masking
- None (open label)
- Enrolment
- 560 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michał Pędziwiatr, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07158008
- Sponsor's protocol ID
- SLEEVE-GERD Trial
- Acronym
- SLEEVE-GERD
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2025
- Last updated
- 5 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD to Be Shared: De-identified individual-level data related to primary and secondary outcomes, including weight loss metrics, GERD scores, and hormone levels. When Available: 12 months after publication of primary results How Long Available: For 3 years after results publication With Whom: Qualified researchers upon request Access Criteria: Requests must include a methodologically sound proposal and data use agreement. Data will be shared via institutional data-sharing platform or secure transfer. For What Types of Analyses: For academic, non-commercial research related to obesity, bariatric surgery, and GERD outcomes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The SLEEVE-GERD Trial: A Comparative Study of Nissen-Sleeve and Roux-en-Y Gastric Bypass in Obese Patients With GERD
- ClinicalTrials.gov ID
- NCT07158008
- Acronym / sponsor ID
- SLEEVE-GERD / SLEEVE-GERD Trial
- Conditions
- Gastro Esophageal Reflux, Severe Obesity, Bariatric Surgery
- Keywords
- Nissen-Sleeve, Gastric Bypass, GERD
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 560 participants (estimated)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Study start
- 31 Jul 2025 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 5 Sep 2025 (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 clinical trial aims to compare two surgical techniques for the treatment of obesity in patients who also have symptoms of gastroesophageal reflux disease (GERD). The study will compare Nissen-Sleeve Gastrectomy (N-SG)-a sleeve gastrectomy combined with a reflux-preventing procedure-to the Roux-en-Y Gastric Bypass (RYGB), which is the current standard surgical option for obese patients with GERD.
Both procedures are widely used to treat severe obesity, but they differ in how they affect the digestive system and the potential for reflux control, nutritional outcomes, and future surgical options. N-SG is a newer technique that preserves the natural pathway of the gastrointestinal tract and allows standard endoscopic access to the bile ducts, which may be beneficial for long-term patient care. RYGB, on the other hand, bypasses part of the stomach and small intestine, which may lead to better reflux resolution but carries risks of nutritional deficiencies and altered anatomy.
Eligible participants with obesity and GERD symptoms will be randomly assigned to receive either N-SG or RYGB. The primary goal is to evaluate whether N-SG is not inferior to RYGB in reducing GERD symptoms one year after surgery. Secondary outcomes include weight loss, quality of life, surgical complications, and changes in the hormone ghrelin, which is involved in appetite regulation.
In addition, a larger control group of patients without GERD undergoing standard sleeve gastrectomy will be recruited to allow further comparisons. All participants will be followed for one year after surgery, with blood samples, questionnaires, and clinical data collected to assess both metabolic and reflux-related outcomes.
This study is being conducted at the University Hospital in Kraków, Poland, and aims to improve the personalization of bariatric treatment for patients suffering from both obesity and reflux.
Detailed description
This randomized clinical trial is designed to compare the safety and effectiveness of Nissen-Sleeve Gastrectomy (N-SG) versus Roux-en-Y Gastric Bypass (RYGB) in patients with obesity and symptoms of gastroesophageal reflux disease (GERD). N-SG is a modified sleeve gastrectomy procedure that incorporates an anti-reflux mechanism based on the Nissen fundoplication technique, while RYGB is a well-established bariatric procedure with proven anti-reflux efficacy.
Background and Rationale:
Severe obesity (BMI ≥ 40 or ≥ 35 with comorbidities) is a growing health problem and is frequently associated with GERD. While sleeve gastrectomy (SG) is currently the most widely performed bariatric procedure globally, it has been associated with the development or worsening of GERD in a significant number of cases. RYGB has become the standard surgical approach in obese patients with pre-existing GERD due to its high rate of reflux symptom resolution. However, RYGB involves more complex anatomical changes, carries a risk of nutritional deficiencies, and limits future endoscopic access to the biliary tract.
The Nissen-Sleeve Gastrectomy (N-SG), first described by David Nocca in 2016, combines SG with a 360-degree gastric fundoplication wrap (similar to that used in traditional Nissen fundoplication). This technique preserves gastrointestinal continuity and potentially maintains endoscopic access to the duodenum, while adding a reflux barrier. Early observational studies suggest favorable outcomes in terms of GERD resolution while retaining the benefits of SG. However, no large-scale randomized controlled trial has compared N-SG with RYGB in this specific patient population.
Study Design:
This is a prospective, single-center, randomized controlled non-inferiority trial conducted at the University Hospital in Kraków, Poland. Patients with obesity and clinically confirmed GERD will be randomized in a 1:1 ratio to receive either N-SG or RYGB. Randomization is performed using a computer-generated block randomization schedule. Allocation will be concealed in sealed envelopes and opened immediately prior to surgery. The estimated sample size for the randomized arms is 140 patients (70 per group), accounting for an assumed 15% dropout rate, and powered to detect non-inferiority with a margin of 10%.
In addition to the randomized comparison, a non-randomized observational control group of approximately 420 patients undergoing standard SG without GERD symptoms will be enrolled. This group will allow propensity-matched analyses and further comparisons of outcomes.
Surgical Techniques:
Nissen-Sleeve Gastrectomy (N-SG): The greater curvature of the stomach is mobilized, short gastric vessels are divided, and the fundus is used to create a posterior wrap around the distal esophagus. A 360-degree fundoplication (Nissen) is performed laparoscopically. This is followed by longitudinal gastric resection using a 40Fr bougie to calibrate the sleeve.
Roux-en-Y Gastric Bypass (RYGB): A small proximal gastric pouch is created. A 100 cm alimentary (Roux) limb is anastomosed to the pouch. A biliopancreatic limb of 150 cm is created via jejunojejunostomy, and the continuity of the gastrointestinal tract is restored. The stomach remnant and duodenum are excluded from the alimentary flow.
Follow-Up and Data Collection:
All patients will be followed for at least 12 months postoperatively. Clinical data will be collected at baseline, postoperatively, and at follow-up visits. Blood samples will be obtained at four time points: (1) day of surgery, (2) first postoperative day, (3) one week post-discharge (during suture removal), and (4) at 12-month follow-up. Blood will be analyzed for serum ghrelin levels using ELISA-based testing.
GERD symptoms will be assessed pre- and postoperatively using the validated GerdQ questionnaire. A score below 5 at 12 months, along with discontinuation of proton pump inhibitor (PPI) therapy for at least 60 days, will be considered remission of GERD.
Outcomes:
Primary outcome: GERD symptom resolution at 12 months post-op, comparing N-SG to RYGB.
Secondary outcomes: Weight loss (measured as %EWL, %TWL, and BMI change), serum ghrelin levels, incidence of postoperative complications (Clavien-Dindo scale), and quality of life metrics.
Control Group:
Patients without GERD undergoing standard SG will serve as an observational control cohort. This group will provide comparative data on weight loss and metabolic changes without the influence of pre-existing reflux disease. Their data will be used for secondary analyses and matched comparisons.
Ethical Considerations:
The study has received approval from the Bioethics Committee of Jagiellonian University Medical College. Written informed consent will be obtained from all participants. Participation is voluntary, and subjects may withdraw at any time. The N-SG technique is investigational in Poland and may only be offered within this trial framework. Patients declining randomization will receive the standard of care (RYGB or SG based on clinical indication).
Potential Risks and Complications:
Both RYGB and SG are well-established surgical procedures. N-SG may be associated with additional risks specific to fundoplication, such as cuff leak or stenosis. These complications will be managed with standard endoscopic or surgical protocols as needed. All participants will be closely monitored throughout the study.
This trial seeks to evaluate whether N-SG can offer equivalent reflux control to RYGB while avoiding the anatomical disruption and long-term risks associated with bypass surgery. The results may support broader adoption of N-SG as a tailored option for obese patients with GERD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Participants with obesity and gastroesophageal reflux disease (GERD) symptoms are randomly assigned in a 1:1 ratio to undergo either Nissen-Sleeve Gastrectomy (N-SG) or Roux-en-Y Gastric Bypass (RYGB). Randomization is stratified and block-based, with allocation concealed using sealed envelopes. A third, non-randomized observational cohort of patients without GERD undergoing standard sleeve gastrectomy (SG) is included to allow matched secondary analyses. The primary comparison is between the two randomized arms (N-SG vs. RYGB).
| Arm | Type | Receives |
|---|---|---|
| Nissen-Sleeve Gastrectomy (N-SG) | Experimental | Procedure: Nissen-Sleeve Gastrectomy (N-SG)Participants in this arm will undergo laparoscopic sleeve gastrectomy combined with Nissen fundoplication. The procedure includes partial preservation of the gastric fundus to form a 360-degree wrap around the distal esophagus, followed by sleeve resection of the remaining stomach. This technique aims to provide both weight loss and reflux control while maintaining gastrointestinal continuity. |
| Roux-en-Y Gastric Bypass (RYGB) | Active comparator | Procedure: Roux-en-Y Gastric Bypass (RYGB)Participants in this arm will undergo standard laparoscopic Roux-en-Y gastric bypass. The procedure includes the creation of a small gastric pouch, a 100 cm alimentary (Roux) limb, and a 150 cm biliopancreatic limb. The bypass alters the gastrointestinal anatomy to promote weight loss and has established effectiveness in reducing GERD symptoms. |
| Sleeve Gastrectomy - Control (No GERD) | Other | Procedure: Sleeve Gastrectomy (SG)This non-randomized observational group includes patients without GERD symptoms undergoing standard sleeve gastrectomy. Data from this group will be used for secondary matched analyses to evaluate weight loss and hormonal changes, serving as a control for comparative evaluation with the randomized arms. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Age ≥ 18 years
- Written informed consent provided
- Eligible for bariatric surgery according to national guidelines (BMI ≥ 40 kg/m² or BMI ≥ 35 kg/m² with obesity-related comorbidities)
- Presence of symptomatic gastroesophageal reflux disease (GERD), defined by at least one of the following:
- Regular use of proton pump inhibitors (PPIs)
Key exclusion criteria (6 listed)
- History of prior anti-reflux surgery
- History of upper gastrointestinal tract surgery
- Active smoking or history of nicotine use
- Severe cardiac insufficiency (New York Heart Association Class III or IV)
- Pregnancy or planned pregnancy during the study period (if applicable based on future additions)
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 |
|---|---|---|
| Nissen-Sleeve Gastrectomy (N-SG)Laparoscopic Nissen-Sleeve Gastrectomy is a modification of standard sleeve gastrectomy that incorporates an anti-reflux procedure. The greater curvature of the stomach is mobilized and short gastric vessels are divided. A segment of the gastric fundus is preserved and passed behind the distal esophagus to create a 360-degree wrap (Nissen fundoplication) around the lower esophageal sphincter. The crura of the diaphragm are approximated if necessary. Following fundoplication, the remainder of the stomach is resected longitudinally over a 40 French bougie using a linear stapling device, creating a tubular gastric conduit. This approach aims to achieve weight loss while providing a functional anti-reflux barrier and maintaining gastrointestinal continuity. | Procedure or surgery | Nissen-Sleeve Gastrectomy (N-SG) |
| Roux-en-Y Gastric Bypass (RYGB)Laparoscopic Roux-en-Y Gastric Bypass is a standard bariatric procedure that combines gastric restriction with intestinal bypass. A small proximal gastric pouch is created using linear staplers, completely separating it from the gastric remnant. A 100 cm alimentary (Roux) limb of jejunum is measured from the ligament of Treitz and anastomosed to the gastric pouch (gastrojejunostomy) using a linear stapler. A jejunojejunostomy is then performed 150 cm distal to the gastrojejunostomy to connect the biliopancreatic limb to the alimentary limb, restoring intestinal continuity. The mesenteric defects are closed to reduce the risk of internal hernia. This procedure promotes weight loss and has established effectiveness in reducing gastroesophageal reflux symptoms. | Procedure or surgery | Roux-en-Y Gastric Bypass (RYGB) |
| Sleeve Gastrectomy (SG)Laparoscopic Sleeve Gastrectomy is a restrictive bariatric procedure involving longitudinal resection of the stomach to create a tubular gastric conduit. The greater curvature is mobilized and short gastric vessels are divided. Using a bougie as a guide, the stomach is divided with a linear stapling device from the antrum to the angle of His, removing approximately 75-80% of gastric volume, including most of the fundus. This reduces stomach capacity and ghrelin production, promoting weight loss while maintaining gastrointestinal continuity. | Procedure or surgery | Sleeve Gastrectomy - Control (No GERD) |
Primary outcome
GERD Symptom Remission
Time frame: 12 months post-surgery
Resolution of GERD symptoms, defined as: No need for proton pump inhibitors (PPIs) for at least 60 consecutive days, and GerdQ questionnaire score < 7 at 12-month follow-up. Comparison between Nissen-Sleeve Gastrectomy (N-SG) and Roux-en-Y Gastric Bypass (RYGB) arms.
7 secondary outcomes
Percent Excess Weight Loss (%EWL)
Time frame: 12 months post-surgery
Percent Total Weight Loss (%TWL)
Time frame: 12 months post-surgery
Change in Body Mass Index (BMI)
Time frame: Difference in BMI from baseline to 12 months. Compared across all three study arms.
Change in Serum Ghrelin Levels
Time frame: Baseline (day of surgery), postoperative day 1, day 7 after discharge, and 12 months post-surgery
Postoperative Complication Rate (Clavien-Dindo Classification ≥ Grade III)
Time frame: Up to 30 days post-surgery
Quality of Life (QoL) Score
Time frame: 12 months post-surgery
GERD Related Quality of Life
Time frame: 12 months post-surgery
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 5 Sep 2025.
- Individual participant dataSharing planned: Yes. IPD to Be Shared: De-identified individual-level data related to primary and secondary outcomes, including weight loss metrics, GERD scores, and hormone levels. When Available: 12 months after publication of primary results How Long Available: For 3 years after results publication With Whom: Qualified researchers upon request Access Criteria: Requests must include a methodologically sound proposal and data use agreement. Data will be shared via institutional data-sharing platform or secure transfer. For What Types of Analyses: For academic, non-commercial research related to obesity, bariatric surgery, and GERD outcomes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nissen-Sleeve Gastrectomy (N-SG), Roux-en-Y Gastric Bypass (RYGB) and Sleeve Gastrectomy (SG) in people with Gastro Esophageal Reflux and Severe Obesity, run by Jagiellonian University at 1 site in Poland.
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 13 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 5 Sep 2025. 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 Poland. 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?
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 Piotr Małczak, PhD, MD (0048124002600, piotr.malczak@uj.edu.pl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD Symptom Remission (time frame: 12 months post-surgery). 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 5 Sep 2025.