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

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

Interventions

PROCEDURE

Total revision of Roux-en-Y gastric bypass

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.

Sponsors & Collaborators

• Region Östergötland

  collaborator OTHER

• Linkoeping University

  lead OTHER_GOV

Principal Investigators

• Torsten Olbers, Professor · Linkoeping University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

25 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-02-01

Primary Completion

2028-01-31

Completion

2035-01-31

Countries

• Sweden

Study Locations