Revision Surgery for Suboptimal Weight Loss or Recurrent Weight Gain After Roux-en-Y Gastric Bypass

NCT06857578 | Active Not Recruiting DMC

• 1 other identifier: 2024-07210-01
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The majority of those who undergo gastric bypass surgery have a good/sufficient weight loss, averaging 25-30% after 10-20 years (Adams TD NEJM -18). In a subgroup analysis in LABS, 5% of RYGB patients had an unfavourable weight development with an average of only up to 10% weight loss 7 years after surgery (Courcoulas et al, JAMA Surg -18). These data are in good agreement with data in the Scandinavian quality registry SOReg where 5-10% an insufficient weight loss/weight recurrence 10 years after gastric bypass (SOReg annual report -20). Insufficient weight loss/weight recurrence after gastric bypass can for the individual, in addition to the negative effects on quality of life, mean that comorbidities to obesity are insufficiently controlled or recur. This applies not least to weight-related problems, such as osteoarthritis in the lower extremities where joint replacement surgery can be prevented by too high a body weight. In summary, one in ten patients who undergo bariatric surgery with the gastric bypass method will therefore have an insufficient effect of the procedure in the long term. The first-line treatment is a review of what can be done with diet and exercise, which, however, usually has a very limited effect. In recent years, the addition of medications has become an alternative, but the effect is variable and insufficiently studied over a longer period of time. These medications are also not included in the high-cost coverage. The surgical method that has so far gained the most popularity in gastric bypass reoperation is the so-called "distal gastric bypass". In distal gastric bypass, the part of the intestine where much of the nutrient absorption occurs is so short that all nutrients (fat) are not fully absorbed. Although this method can be effective for weight loss, it often has significant side effects such as diarrhea and deficiencies of minerals and fat-soluble vitamins. Over the past decade, knowledge about the mechanism of action of gastric bypass surgery has increased significantly. It is primarily changes in hunger and satiety signals from the gastrointestinal system to the brain that lead to sustained weight loss. Studies have shown that poorer weight loss is associated with a weaker response to satiety signals compared to those who lose more than average weight, where instead the response is strong. Based on knowledge of the importance of satiety signals, initial experiences have been gained with a new type of revision surgery to amplify the effect in satiety signalling in gastric bypass patients with inadequate weight control. The results of these surgeries have generally been positive, even if not all achieved significant weight loss. This project will systematically study whether a new type of revision surgery is safe and sufficiently effective to achieve the desired weight loss and improve comorbidity in patients who have responded inadequately or regained weight after gastric bypass surgery.

Conditions

Obesity and Obesity-related Medical Conditions

Keywords

revisional bariatric surgery; Roux-en-Y gastric bypass

Outcome Measures

Primary Outcomes (1)

• Weight loss (kg)

  We will consider the experimental procedure effective provided that 80% of participants lose at least 10% of preoperative weight

  2 years

Secondary Outcomes (8)

• Complication to surgery

  2 years

• Side effects to the gastro-intestinal reconstruction

  2 years

• Change in obesity comorbidity

  2 years

• Waist circumference

  2 years

• Change in physical quality of life

  2 years

Study Arms (1)

Total revision of Roux-en-Y gastric bypass

EXPERIMENTAL

A complete revision of the previously performed Roux-en-Y gastric bypass

Procedure: Total revision of Roux-en-Y gastric bypass

Interventions

Total revision of Roux-en-Y gastric bypass PROCEDURE

1. The entire previous gastric bypass construction is released from any adhesions and all parts of the small intestine are measured and assessed. 2. All or parts of the first part of the intestine that food reaches after the gastric pouch (so-called Roux) is resected. The reason is that parts of the intestine that are considered to be of poor quality (for example, affected by a lot of adhesions or abnormally dilated) are removed. This can be about 1.5 meters of intestine, which corresponds to 10-25% of the entire length of the small intestine. The gastric pouch will be small (\<30 ml). 3. A new gastric bypass construction is constructed where the intestine receiving food from the esophagus (Roux) will be 1 meter, and the small intestine part from the closed stomach at least 1.5 meters. The remaining length of the small intestine below the jejuno-jejunal anastomosis should be minimum 3 meters.

Total revision of Roux-en-Y gastric bypass

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Body weight within 10% of initial weight
• \>2 year after primary Roux-en-Y gastric bypass procedure
• Able to comprehend intended benefits and risks
• Understand the Swedish language
• Not responding sufficiently to life style intervention
• Be aware about available pharmacological interventions

You may not qualify if:

• Inflammatory bowel disease
• Below 25 or above 60 years of age

Sponsors & Collaborators

• Linkoeping University: lead
• Region Östergötland: collaborator

Study Sites (1)

Dept of Surgery, Vrinnevi hospital

Norrköping, Östergötland County, Sweden

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

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

Study Officials

• Torsten Olbers, Professor

  Linkoeping University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Efficacy and safety study

Study Record Dates

• First Submitted: February 18, 2025
• First Posted: March 4, 2025
• Study Start: February 1, 2025
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): January 31, 2035
• Last Updated: March 4, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)