Comparison of Two Surgical Techniques for Treatment of Type III Obesity (BMI 40-50 kg/m2): Single Anastomosis Duodenoileal Bypass With Sleeve Gastrectomy and Roux-en-Y Gastric Bypass.

NCT06789965 | Recruiting

• 1 other identifier: HCB/2024/0752
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief Summary

Roux-en-Y gastric bypass (RY-GBP) is one of the surgical techniques most widely used for the treatment of obesity. Long series of operated patients published in the literature have demonstrated its safety and efficacy. It consists on the reduction of the size of the stomach and joining it (anastomosis) with the small bowel to reduce the absorption of calories. Single anastomosis duodenoileal with sleeve gastrectomy is an increasingly used surgical technique that is a simplification of the duodenal switch. It consists on the reduction of the stomach to a tube (sleeve gastrectomy) and an anastomosis between the duodenum and the small bowel. It has been demonstrated as a effective technique and it is supported by the international scientific societies. There are no data that indicate a superiority of one technique over the other. The objective of this study is to analyze if there are differences between the two techniques in terms of postoperative weight control and gastroesophageal reflux at short, medium and long term.

Conditions

Obesity

Keywords

obesity; sadi-s; ry-gbp; weight loss; metabolic complications; sadis; gbp; rygbp; bariatric surgery

Outcome Measures

Primary Outcomes (4)

• % of patients with Total weight loss at 2 years > 30%

  % of patients with Total weight loss at 2 years \> 30%

  2 years after intervention

• % of patients with Total weight loss at 5 years > 30%

  % of patients with Total weight loss at 5 years \> 30%

  5 years after intervention

• Short term postoperative complications

  Complications classified as Clavien-Dindo III or IV (requiring reintervention, endoscopic or radioguided interventional treatment, or admission to the ICU).

  From intervention to the end of the short term at 30 days after surgery.

• Middle to long-term postoperative complications

  In the medium to long term, any complication that requires reintervention, endoscopic or radioguided interventional treatment, ICU admission, maintained parenteral or enteral nutrition, or specific parenteral treatment is included. This encompasses complications attributable to bariatric surgery, such as intestinal obstruction, internal hernia, diarrhea, hypoglycemia, dumping syndrome, malnutrition, ulcer, and GERD. Reintervention due to incisional hernia, cholecystectomy, or causes unrelated to bariatric surgery is excluded.

  From 30 days after intervention to the end of the study 5 years after the intervention.

Secondary Outcomes (9)

• Digestive symptoms at 2 years after surgery

  From the intervention up to 2 years after surgery

• Digestive symptoms at 5 years after surgery

  From the 2nd year until the end of the follow-up 5 years after the intervention.

• Endoscopic findings at 2 years

  From the intervention up to 2 years after surgery

• Postoperative morbidity and mortality

  From the intervention up to 90 days after surgery

• Resolution of metabolic comorbidities at 2 years

  From the intervention up to 2 years after surgery

Study Arms (2)

SADI-S

EXPERIMENTAL

The complete dissection of the antrum and the first portion of the duodenum is performed up to the limit of the gastroduodenal artery. The right gastric artery is dissected, clipped, and sectioned at its root. A vertical gastrectomy is created using a 38F Foucher tube with staplers. Next, the duodenum is sectioned with a stapler, and the resection of the greater gastric curvature is completed. Then, from the left side of the patient, 250 cm is measured from the ileocecal valve, where the duodenoileal anastomosis will be performed. This anastomosis is carried out with the surgeon positioned again between the patient's legs. A manual end-to-side anastomosis with two layers of monofilament is performed. Finally, the vertical gastrectomy and the duodenoileal anastomosis are verified using intraoperative endoscopy or a methylene blue and air test. The gastrectomy specimen is removed through the left pararectal trocar incision. A drain will only be placed in cases of special technical diff

Procedure: SADI-S

RY-GBP

ACTIVE COMPARATOR

In the case of RY-GBP, first, the lesser gastric curvature is dissected between the cardia and the angular incisura, accessing the gastric transcavity. A horizontal gastric transection is performed using the first firing of a stapler. A gastric reservoir is created through successive firings with a 38F Foucher tube stapler. Next, 100 cm of the biliopancreatic limb is measured, where the manual or semi-mechanical gastrojejunostomy will be performed, with an end-to-side anastomosis using a stapler and manual closure of the loop. Then, 150 cm of the alimentary limb is measured, and a side-to-side jejunojejunostomy is created. A section is made between the two anastomoses. The mesenteric opening and the Petersen space are closed with a continuous non-absorbable suture. The anastomosis is verified using intraoperative endoscopy or a methylene blue and air test. A drain will only be placed in cases of special technical difficulty or intraoperative complications.

Procedure: RY-GBP

Interventions

SADI-S PROCEDURE

In the case of SADI-S, the complete dissection of the antrum and the first portion of the duodenum is performed up to the limit of the gastroduodenal artery. The right gastric artery is dissected, clipped, and sectioned at its root. A vertical gastrectomy is created using a 38F Foucher tube with staplers. Next, the duodenum is sectioned with a stapler, and the resection of the greater gastric curvature is completed. Then, from the left side of the patient, 250 cm is measured from the ileocecal valve, where the duodenoileal anastomosis will be performed. This anastomosis is carried out with the surgeon positioned again between the patient's legs. A manual end-to-side anastomosis with two layers of monofilament is performed. Finally, the vertical gastrectomy and the duodenoileal anastomosis are verified using intraoperative endoscopy or a methylene blue and air test. The gastrectomy specimen is removed through the left pararectal trocar incision. A drain will only be placed in cases of s

SADI-S

RY-GBP PROCEDURE

In the case of RY-GBP, first, the lesser gastric curvature is dissected between the cardia and the angular incisura, accessing the gastric transcavity. A horizontal gastric transection is performed using the first firing of a stapler. A gastric reservoir is created through successive firings with a 38F Foucher tube stapler. Next, 100 cm of the biliopancreatic limb is measured, where the manual or semi-mechanical gastrojejunostomy will be performed, with an end-to-side anastomosis using a stapler and manual closure of the loop. Then, 150 cm of the alimentary limb is measured, and a side-to-side jejunojejunostomy is created. A section is made between the two anastomoses. The mesenteric opening and the Petersen space are closed with a continuous non-absorbable suture. The anastomosis is verified using intraoperative endoscopy or a methylene blue and air test. A drain will only be placed in cases of special technical difficulty or intraoperative complications.

RY-GBP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• BMI 40 - 50 Kg/m2
• Candidates to mixed bariatric surgery

You may not qualify if:

• \< 18 years.
• \> 60 years.
• BMI \< 40 Kg/m2
• BMI \> 50 Kg/m2.
• Non-candidates to mixed bariatric surgery.

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic Barcelona

Barcelona, Barcelona, 08036, Spain

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Obesity; Weight Loss

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Body Weight Changes

Study Officials

• Javier Osorio, PhD

  General & Digestive Surgery Department, ICMDM, Clinic Barcelona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Javier Osorio, PhD

CONTACT

+34932275400; josorio@clinic.cat

Victor Turrado-Rodriguez, MD

CONTACT

+34932275400; turrado@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2024
• First Posted: January 23, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2030
• Last Updated: May 4, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Beginning 1 year after publication with no end date.
• Access Criteria: The requests for IPD sharing will be reviewed by the IP and a committee of the IPs from the different centers. Access will be granted for systematic reviews and metaanalysis.

Locations

ES (1)