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NCT Number: NCT06204939

Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With BMI≥45

The classic RYGB is in most patients with a BMI ≥45 technically not feasible. Two alternatives are the Extended Pouch Gastric Bypass and the One Anastomosis gastric bypass. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Obesity is of increasing incidence worldwide. With it come major social-economical, medical and psychological problems which lead to high healthcare costs. Bariatric surgery is the most efficient treatment for morbid obesity, with the Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (GS) being the most performed.

The RYGB is preferable since this technique seems to lead to more reduction of obesity related comorbidities (DM2) and more weightloss in the long term. However, the RYGB is technically less feasible in patients with a BMI ≥45, due to less intra-abdominal space (excess fat in mesenterium) to connect the anastomosis tension-free.

An alternative for the RYGB are the Extended Pouch gastric bypass (EPGB) and the One-Anastomosis gastric bypass (OAGB). These techniques both involve an extended pouch which makes it easier to connect the anastomosis tension-free.

Furthermore, the extended pouch in the EPGB and OAGB could provide slower passage of food and stretches less on the longer term than the 'normal size'pouch in the RYGB, possibly leading to more weightloss (1,2).

Previous studies comparing the EPGB and RYGB showed more weightloss in patient undergoing EPGB and less weight gain in the long term (3). Other studies comparing the OAGB, RYGB and GS showed non-inferiority or even superiority of the OAGB for weightloss and remission of obesity related comorbidities as diabetes mellitus type 2 (DM2) and obstructive sleep apnea syndrome (OSAS) (4,5,6,7).

Theoretically the OAGB is a simpler procedure which reduces the risk of internal herniation and anastomotic leakage, since only one anastomosis is made (6,8) Only performing one anastomosis leads to less operating time, shorter time of anesthesia, and less usage of staple material. Which possibly makes this a safer and cheaper procedure.

Both techniques, EPGB and OAGB, seem to be adequate alternatives for the RYGB in patients with a BMI of 45 or higher. As of yet, the two techniques haven't been compared one to one. In this single blinded randomized controlled trial the investigators aim to establish which technique leads to more weightloss in bariatric patients with a BMI ≥45.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • BMI≥45
  • Bariatric guidelines Fried
  • Age 18-65
  • Dedication to guided preoperative program
  • Intention to follow full postoperative program

Exclusion criteria

  • Secondary bariatric procedure
  • Medical(-related) cause for morbid obesity or fast weight gain (e.g. Cushing or medication related)
  • Inflammatory Bowel Disease (M. Crohn or Colitis Ulcerosa)
  • Renal function disorder (MDRD <30) or liver disease
  • Anticipated absence of yearly medical follow up
  • Does not speak Dutch language
  • Pregnancy

Treatment and study plan

Randomizing for EPGB procedure

Procedure

Classic gastric bypass with 2 anastomoses but with an extended pouch of 12-15cm and a biliary limb of 150cm.

Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB.

Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires.

Randomizing for OAGB procedure

Procedure

Gastric bypass with 1 anastomosis and an extended pouch of 12-15cm and a biliary limb of 150cm.

Patients will be single blinded randomized for one of the two procedures. 125 patients will undergo EPGB and 125 patients will undergo OAGB.

Pre-operatively, 6 months post-op and yearly post-op we will collect: weight, complications, revisions, comorbidities, blood samples and questionnaires.

Primary outcomes

  1. Weightloss short term

    Time frame: 1, 3 and 5 years postoperatively

    percentage excess weight loss

Secondary outcomes

  1. Weightloss long term

    Time frame: 5-10 years postoperatively

    percentage excess weight loss

  2. Complications short term

    Time frame: up to 30 days postoperatively

    bleeding, leakage, infections, intra-abdominal abcess, readmission, mortality

  3. Complications long term

    Time frame: from 30 days until 10 years postoperatively

    vitamin/electrolyte deficiencies, internal herniation, marginal ulceration

  4. Revision of the bypass

    Time frame: until 10 years postoperatively

    Surgical revision of bypass

  5. Comorbidities

    Time frame: until 10 years postoperatively

    Reduction of obesity-related comorbidites: diabetes mellitus type 2, hypertension, hypercholesterolemia, joint aches en obstructive sleep apnea syndrome

  6. Deficiencies in blood - red blood count

    Time frame: until 10 years postoperatively

    Blood samples: red blood count

  7. Deficiencies in blood - vitamins

    Time frame: until 10 years postoperatively

    Blood samples vitamins

  8. Deficiencies in blood - electrolytes

    Time frame: until 10 years postoperatively

    Blood samples: electrolytes

  9. Reflux/dumping questionnaire

    Time frame: until 10 years postoperatively

    Questionnaires for reflux and dumping complaints. scales 0-10, higher is worse outcome

  10. Health related quality of life questionnaire

    Time frame: until 10 years postoperatively

    Questionnaires on HrQoL and patient satisfaction of procedure, scales 0-5 and 0-10, higher is worse outcome

  11. Peroperative complications

    Time frame: until 10 years postoperatively

    Peroperative complications: bleeding, iatrogenic complications

  12. Number of patients with peroperative conversion to sleeve

    Time frame: until 10 years postoperatively

    Conversion to sleeve when bypass not feasible

Study contacts

Contact information is provided by the study sponsor or research team.

Lilian van Hogezand, MD

CONTACT

[email protected]

+31883206151

Wetenschapsloket St. Antonius Ziekenhuis

CONTACT

[email protected]

+31883208761

Sponsors and collaborators

Lead sponsor

L. van Hogezand

Other

Collaborators

  • Rijnstate Hospital

Registry information

Official study title

Extended Pouch Gastric Bypass vs One-anastomosis Gastric Bypass in Patients With a BMI of 45 or Higher: a Randomized Controlled Trial

Acronym: EXPANT

Important dates

Study start
2024
Primary completion
2025
Study completion
2029
First posted
Jan 12, 2024
Registry last updated
Jan 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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