How Does Bariatric Surgery Affect Social Experiences and Well-being

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

113 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-05-12

Study Completion Date

2026-06-30

Brief Summary

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Nonrandomized controlled trial to assess whether or not sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) affect social experiences and biomarkers of well-being 6 weeks and 1 year after surgery. The decision whether SG or RYGB will be performed is determined by medical decision making. Hypotheses: Bariatric surgery influences social experiences and well-being through changes in body image, reward responsivity and gut hormones. These changes may differ between gastric bypass (RYGB) and sleeve gastrectomy (SG).

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Detailed Description

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Explanation for choice of comparators

Obesity is one of the world's most serious public health problems. Conservative weight reduction methods alone (diet, exercise) often show disappointing results, as the majority of people who lose weight regain it after a shorter or longer period of time. The currently most effective measure to achieve a durable weight-loss is bariatric surgery.

When investigating the effectiveness of bariatric surgery, the focus has most often been on weight loss and obesity-related complications, while effects on social interaction and subjective experience have received much less attention. A large body of evidence has demonstrated that (supportive) social relationships benefit health. Individuals with low compared to those with high levels of social connectedness are more likely to die prematurely; and social relationships can also affect a range of other health conditions such as cardiovascular disease, cancer, and immune function. Importantly, individuals with obesity may experience social interactions as less positive than normal-weight individuals. They recount avoiding social events and relationships, but also career opportunities, shopping and other activities where they feel observed because of weight stigma. Such avoidance behavior can lead to a "chronic disengagement" with many aspects of social life, which in turn might decrease interpersonal skills. Further investigations into the link between social behavior and eating found that greater emotional eating is associated with greater social avoidance. Eating was described a means to cope with loneliness on the one hand, while on the other hand aggravating feelings of being alone due to the stigma associated with obesity. This way, loneliness and obesity can create a vicious circle. In terms of how bariatric surgery influences social interactions, one 10-year follow up study found improvements in social interactions for bariatric surgery, but not for conventional weight loss treatment. In qualitative studies, many participants mentioned that they received more positive social feedback following bariatric surgery, and that they enjoyed social activities more than before, although they also describe ambiguous feelings.

The present study will investigate whether and how two types of bariatric surgery improve the response to a range of social aspects of patients' daily lives. Further, it aims to determine potential mechanisms leading to these effects, namely changes in body image, gut hormones, and reward responsivity.

Conditions

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Obesity

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

2 intervention groups with either sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) surgery; in addition one small exploratory group undergoing undergoing single anastomosis sleeve ileal (SASI) bypass

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Gastric bypass

Group Type ACTIVE_COMPARATOR

Gastric bypass

Intervention Type PROCEDURE

In Roux-en-Y gastric bypass (RYGB), the left crus will be dissected free, any hiatal hernia left in place. The minor curvature is opened at the second vessel and the lesser sac entered. A 25 mL gastric pouch will be created by firing one horizontal and two vertical staple loads. The ligament of Treitz is then identified and a proximal loop of small intestine anastomosed to the pouch 60 cm from the ligament of Treitz with one linear stapler (full length of the stapler), creating an antecolic, antegastric alimentary limb. The opening will be closed using a single row, running absorbable suture. An entero-enteroanastomosis will be made 120 cm distal of the gastro-enteroanastomosis. The introductory opening is closed with a single row, running absorbable suture. The small intestine will be divided with one load between the gastro-entero-enteroanastomosis and the entero-enteroanastomosis in order to complete a bypass with an alimentary limb of 120 cm and a biliopancreatic limb of 60 cm.

Sleeve gastrectomy

Group Type ACTIVE_COMPARATOR

Sleeve gastrectomy

Intervention Type PROCEDURE

In sleeve gastrectomy (SG) a large part (80%) of the ventricle is removed. The greater curvature will be dissected free starting 4-5 cm from the pylorus up to the angle of Hiss. The left crus is then visualized and inspected for hiatal hernia. Small sliding hernias and wide hiatus are left in situ. The ventricle will then be lifted and any adhesions in the lesser sac divided. A 35 Fr bougie is placed down to the pylorus guiding the creation of a tubular sleeve with linear staplers. The first two loads are always green or purple, while blue or tan loads are used for the rest of the ventricle. The last stapler is placed 5 mm laterally to the angle of Hiss. The staple line will then be inspected and secured with clips for additional haemostasis, no oversewing or buttressing material is routinely used.

Single anastomosis sleeve ileal (SASI) bypass

Exploratory small arm with a small number of particpants

Group Type EXPERIMENTAL

Single anastomosis sleeve ileal (SASI) bypass

Intervention Type PROCEDURE

The SASI bypass will performed with a similar entry of the abdominal cavity. A 6-port set up and a liver retractor is utilized. The small bowel is measured 300cm from the ileocecal valve, in sequences of 10cm, with the small bowel stretched and markers placed on the graspers, and connected to the antrum of the stomach with a 45mm stapler. The anastomosis is positioned slightly ventral on the antrum. The antrum is opened ventrally 5 cm proximal to the pylorus, just below the horizontal axis of canalis pylori. A 12 mm port positioned left to the midline is used for introduction of the stapler, which is directed distally from the patient's left to right side. 2.5 cm of the 45 mm stapler device is used for firing the anastomosis, which is completed with a 2-0 PDS running suture. The fascia defect is closed for the port where the specimen is extracted. The mesenteric defect is not closed.

Interventions

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Gastric bypass

In Roux-en-Y gastric bypass (RYGB), the left crus will be dissected free, any hiatal hernia left in place. The minor curvature is opened at the second vessel and the lesser sac entered. A 25 mL gastric pouch will be created by firing one horizontal and two vertical staple loads. The ligament of Treitz is then identified and a proximal loop of small intestine anastomosed to the pouch 60 cm from the ligament of Treitz with one linear stapler (full length of the stapler), creating an antecolic, antegastric alimentary limb. The opening will be closed using a single row, running absorbable suture. An entero-enteroanastomosis will be made 120 cm distal of the gastro-enteroanastomosis. The introductory opening is closed with a single row, running absorbable suture. The small intestine will be divided with one load between the gastro-entero-enteroanastomosis and the entero-enteroanastomosis in order to complete a bypass with an alimentary limb of 120 cm and a biliopancreatic limb of 60 cm.

Intervention Type PROCEDURE

Sleeve gastrectomy

In sleeve gastrectomy (SG) a large part (80%) of the ventricle is removed. The greater curvature will be dissected free starting 4-5 cm from the pylorus up to the angle of Hiss. The left crus is then visualized and inspected for hiatal hernia. Small sliding hernias and wide hiatus are left in situ. The ventricle will then be lifted and any adhesions in the lesser sac divided. A 35 Fr bougie is placed down to the pylorus guiding the creation of a tubular sleeve with linear staplers. The first two loads are always green or purple, while blue or tan loads are used for the rest of the ventricle. The last stapler is placed 5 mm laterally to the angle of Hiss. The staple line will then be inspected and secured with clips for additional haemostasis, no oversewing or buttressing material is routinely used.

Intervention Type PROCEDURE

Single anastomosis sleeve ileal (SASI) bypass

The SASI bypass will performed with a similar entry of the abdominal cavity. A 6-port set up and a liver retractor is utilized. The small bowel is measured 300cm from the ileocecal valve, in sequences of 10cm, with the small bowel stretched and markers placed on the graspers, and connected to the antrum of the stomach with a 45mm stapler. The anastomosis is positioned slightly ventral on the antrum. The antrum is opened ventrally 5 cm proximal to the pylorus, just below the horizontal axis of canalis pylori. A 12 mm port positioned left to the midline is used for introduction of the stapler, which is directed distally from the patient's left to right side. 2.5 cm of the 45 mm stapler device is used for firing the anastomosis, which is completed with a 2-0 PDS running suture. The fascia defect is closed for the port where the specimen is extracted. The mesenteric defect is not closed.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* scheduled for bariatric surgery and eligible for sleeve gastrectomy or gastric bypass
* able to give consent
* understand written and spoken Norwegian