Gastric Bypass ComplicationNCT07038148
Single-Stage Stapled Conversion of Gastric Bypass to Sleeve Gastrectomy
A study testing Single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy in people with Gastric Bypass Complication and Obesity, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
Some patients who have had a gastric bypass (Roux-en-Y gastric bypass or one anastomosis gastric bypass) develop long-term problems such as nutritional deficiencies, intractable dumping syndrome, retrograde intussusception or weight regain, and some cannot afford the lifelong vitamin supplements the bypass requires. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastric Bypass Complication, Obesity, Bariatric Surgery Candidate
- What is being tested?
- Single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteEgypt
- Study dates
- 18 Feb 2025to 1 Oct 2026
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 to 70 years
- Adult patients with a previous gastric bypass undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy
Who cannot join
- Reversal of gastric bypass to normal anatomy
- Uncontrolled systemic disease
- Active psychological disorder
- Intraoperative technical difficulties preventing conversion of gastric bypass to sleeve gastrectomy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Exploring the Efficacy of Single Stage Stapled Conversion of Gastric Bypass to Sleeve Gastrectomy, More Leak?
Some patients who have had a gastric bypass (Roux-en-Y gastric bypass or one anastomosis gastric bypass) develop long-term problems such as nutritional deficiencies, intractable dumping syndrome, retrograde intussusception or weight regain, and some cannot afford the lifelong vitamin supplements the bypass requires. When these problems do not respond to non-surgical treatment, the bypass can be reversed to normal anatomy, but many patients refuse reversal because they fear regaining weight. Converting the bypass to a sleeve gastrectomy is an alternative that restores food passage through the duodenum while keeping a restrictive operation.
This single-arm study evaluates the efficacy, safety and patient outcomes of single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy in adults at Kasr Al-Ainy hospitals, Cairo University. Patients are followed for 6 months after surgery for nutritional status, weight regain, quality of life, reflux (GERD) symptoms and postoperative complications, including leak.
Read the detailed description
Background: Laparoscopic gastric bypass, including Roux-en-Y gastric bypass (RYGB) and one anastomosis gastric bypass (OAGB), is one of the most frequently performed metabolic bariatric procedures. As the number of bypass operations increases, complications are reported more often. Most can be managed non-surgically, but a small number of persistent cases require reversal to normal anatomy or conversion to another procedure. Complications that may require conversion include retrograde intussusception, weight regain, intractable dumping syndrome and nutritional deficiencies; the high cost of obligatory postoperative vitamins is a further reason for conversion in low-income countries. Conversion is technically demanding, carries a relatively higher rate of postoperative complications, and data on its outcomes are limited.
Design: Prospective, single-arm interventional study.
Preoperative assessment: Patients attending the bariatric outpatient clinic who meet the eligibility criteria are enrolled after patient education. History, anthropometric measures, chronic diseases and previous surgeries are recorded. Routine preoperative laboratory tests and imaging are performed, together with a preoperative 3D CT gastric volumetry.
Surgical technique: After pneumoperitoneum and laparoscopic port placement, the previous gastrojejunostomy is closed with an endostapler applied across the anastomosis and fired on the jejunal side. The end of the gastric pouch is then anastomosed to the remnant stomach with an endostapler. A 36 Fr orogastric tube is passed through the anastomosis as a guide, and a sleeve gastrectomy is performed by resecting the stomach along the greater curvature with endostaplers. An intraoperative methylene blue leak test is performed, hemostasis along the staple line is confirmed, and all ports are closed.
Postoperative care and follow-up: Patients stay in hospital for about 24 hours for monitoring of vital signs and the feeding regimen. Nutritional laboratory parameters (hemoglobin, ferritin, vitamin D, zinc, magnesium, serum albumin and calcium), quality of life (Bariatric Quality of Life Index) and GERD symptoms (GERD-HRQL questionnaire) are assessed at 3 and 6 months after surgery. Body weight is recorded monthly to assess weight regain.
Sample size: Calculated with the ClinCalc sample size calculator (alpha 0.05, power 0.80) as 11 patients, including 10% to cover loss to follow-up. A convenience sample of eligible patients is enrolled until this number is reached.
Statistical analysis: SPSS version 21. Categorical data as number and percentage; quantitative data as mean and standard deviation or median and interquartile range. Chi-square, Student t and Mann-Whitney tests, with correlation and regression analysis. Significance at p of 0.05 or less.
- Being tested
- Single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy
- Keywords
- Conversion of gastric bypass, Revisional metabolic bariatric surgery, Sleeve gastrectomy, Roux-en-Y gastric bypass, One anastomosis gastric bypass, Staple line leak, Dumping syndrome, Weight regain
- Medical subject headings
- Obesity, Dumping Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomyProcedure or surgery
Stapled closure of the previous gastrojejunostomy on the jejunal side, stapled anastomosis of the gastric pouch to the remnant stomach, then sleeve gastrectomy along the greater curvature over a 36 Fr orogastric tube, with an intraoperative methylene blue leak test.
| Study group | Role | What they receive |
|---|---|---|
| Conversion to sleeve gastrectomy | Experimental | Adults with a previous gastric bypass (RYGB or OAGB) undergoing single-stage laparoscopic stapled conversion to sleeve gastrectomy. Receives: Procedure: Single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative leak
Number of participants with a staple-line or anastomotic leak after single-stage stapled conversion of gastric bypass to sleeve gastrectomy.
Measured: From surgery up to 6 months after surgery
Change in nutritional status
Nutritional status assessed with laboratory parameters: hemoglobin, serum ferritin, vitamin D, zinc, magnesium, serum albumin and calcium.
Measured: Preoperatively, and at 3 and 6 months after surgery
Weight regain
Body weight (kg) recorded monthly after conversion to assess weight regain.
Measured: Monthly from surgery up to 6 months after surgery
Secondary outcomes (3)
Quality of life (Bariatric Quality of Life Index)
Quality of life assessed with the Bariatric Quality of Life (BQL) Index.
Measured: 3 and 6 months after surgery
GERD symptoms (GERD-Health Related Quality of Life questionnaire)
Gastroesophageal reflux symptoms assessed with the GERD-Health Related Quality of Life (GERD-HRQL) questionnaire.
Measured: 3 and 6 months after surgery
Other postoperative complications
Number of participants with postoperative complications other than leak, including bleeding and stricture.
Measured: From surgery up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start18 Feb 2025
- Primary completion1 Oct 2026
- Study completion1 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric Bypass ComplicationStudies 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
- Not applicable
- Intervention model
- Single group
- Model description
- All participants undergo single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy and are followed for 6 months.
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelsalam M, Cairo University
- Investigators
- Ahmed Mohamed Abdelsalam, MD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038148
- Sponsor's protocol ID
- N-8-2025
- Status last verified
- Oct 2026
- First submitted
- 25 Jan 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- 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 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Efficacy of Single Stage Stapled Conversion of Gastric Bypass to Sleeve Gastrectomy, More Leak?
- ClinicalTrials.gov ID
- NCT07038148
- Acronym / sponsor ID
- N-8-2025
- Keywords
- Conversion of gastric bypass, Revisional metabolic bariatric surgery, Sleeve gastrectomy, Roux-en-Y gastric bypass, One anastomosis gastric bypass, Staple line leak, Dumping syndrome, Weight regain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 18 Feb 2025 (actual)
- Primary completion
- 1 Oct 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 26 Jun 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.
Some patients who have had a gastric bypass (Roux-en-Y gastric bypass or one anastomosis gastric bypass) develop long-term problems such as nutritional deficiencies, intractable dumping syndrome, retrograde intussusception or weight regain, and some cannot afford the lifelong vitamin supplements the bypass requires. When these problems do not respond to non-surgical treatment, the bypass can be reversed to normal anatomy, but many patients refuse reversal because they fear regaining weight. Converting the bypass to a sleeve gastrectomy is an alternative that restores food passage through the duodenum while keeping a restrictive operation.
This single-arm study evaluates the efficacy, safety and patient outcomes of single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy in adults at Kasr Al-Ainy hospitals, Cairo University. Patients are followed for 6 months after surgery for nutritional status, weight regain, quality of life, reflux (GERD) symptoms and postoperative complications, including leak.
Detailed description
Background: Laparoscopic gastric bypass, including Roux-en-Y gastric bypass (RYGB) and one anastomosis gastric bypass (OAGB), is one of the most frequently performed metabolic bariatric procedures. As the number of bypass operations increases, complications are reported more often. Most can be managed non-surgically, but a small number of persistent cases require reversal to normal anatomy or conversion to another procedure. Complications that may require conversion include retrograde intussusception, weight regain, intractable dumping syndrome and nutritional deficiencies; the high cost of obligatory postoperative vitamins is a further reason for conversion in low-income countries. Conversion is technically demanding, carries a relatively higher rate of postoperative complications, and data on its outcomes are limited.
Design: Prospective, single-arm interventional study.
Preoperative assessment: Patients attending the bariatric outpatient clinic who meet the eligibility criteria are enrolled after patient education. History, anthropometric measures, chronic diseases and previous surgeries are recorded. Routine preoperative laboratory tests and imaging are performed, together with a preoperative 3D CT gastric volumetry.
Surgical technique: After pneumoperitoneum and laparoscopic port placement, the previous gastrojejunostomy is closed with an endostapler applied across the anastomosis and fired on the jejunal side. The end of the gastric pouch is then anastomosed to the remnant stomach with an endostapler. A 36 Fr orogastric tube is passed through the anastomosis as a guide, and a sleeve gastrectomy is performed by resecting the stomach along the greater curvature with endostaplers. An intraoperative methylene blue leak test is performed, hemostasis along the staple line is confirmed, and all ports are closed.
Postoperative care and follow-up: Patients stay in hospital for about 24 hours for monitoring of vital signs and the feeding regimen. Nutritional laboratory parameters (hemoglobin, ferritin, vitamin D, zinc, magnesium, serum albumin and calcium), quality of life (Bariatric Quality of Life Index) and GERD symptoms (GERD-HRQL questionnaire) are assessed at 3 and 6 months after surgery. Body weight is recorded monthly to assess weight regain.
Sample size: Calculated with the ClinCalc sample size calculator (alpha 0.05, power 0.80) as 11 patients, including 10% to cover loss to follow-up. A convenience sample of eligible patients is enrolled until this number is reached.
Statistical analysis: SPSS version 21. Categorical data as number and percentage; quantitative data as mean and standard deviation or median and interquartile range. Chi-square, Student t and Mann-Whitney tests, with correlation and regression analysis. Significance at p of 0.05 or less.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants undergo single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy and are followed for 6 months.
| Arm | Type | Receives |
|---|---|---|
| Conversion to sleeve gastrectomy | Experimental | Procedure: Single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomyAdults with a previous gastric bypass (RYGB or OAGB) undergoing single-stage laparoscopic stapled conversion to sleeve gastrectomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 to 70 years
- Adult patients with a previous gastric bypass undergoing single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy
Key exclusion criteria (4 listed)
- Reversal of gastric bypass to normal anatomy
- Uncontrolled systemic disease
- Active psychological disorder
- Intraoperative technical difficulties preventing conversion of gastric bypass to sleeve gastrectomy
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 |
|---|---|---|
| Single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomyStapled closure of the previous gastrojejunostomy on the jejunal side, stapled anastomosis of the gastric pouch to the remnant stomach, then sleeve gastrectomy along the greater curvature over a 36 Fr orogastric tube, with an intraoperative methylene blue leak test. | Procedure or surgery | Conversion to sleeve gastrectomy |
Primary outcome
Postoperative leak
Time frame: From surgery up to 6 months after surgery
Number of participants with a staple-line or anastomotic leak after single-stage stapled conversion of gastric bypass to sleeve gastrectomy.
Change in nutritional status
Time frame: Preoperatively, and at 3 and 6 months after surgery
Nutritional status assessed with laboratory parameters: hemoglobin, serum ferritin, vitamin D, zinc, magnesium, serum albumin and calcium.
Weight regain
Time frame: Monthly from surgery up to 6 months after surgery
Body weight (kg) recorded monthly after conversion to assess weight regain.
3 secondary outcomes
Quality of life (Bariatric Quality of Life Index)
Time frame: 3 and 6 months after surgery
GERD symptoms (GERD-Health Related Quality of Life questionnaire)
Time frame: 3 and 6 months after surgery
Other postoperative complications
Time frame: From surgery up to 6 months after surgery
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 3 Nov 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.
Ahmed Mohamed Abdelsalam, MD principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Single-stage laparoscopic stapled conversion of gastric bypass to sleeve gastrectomy in people with Gastric Bypass Complication and Obesity, run by Kasr El Aini Hospital 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 2 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 3 Nov 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?
Postoperative leak (time frame: From surgery up to 6 months after surgery). The study lists 3 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 3 Nov 2026.