How Does Bariatric Surgery Affect Social Experiences and Well-being - The BaSES-study

Официальное название

How Gastric Bypass and Sleeve Gastrectomy Change Social Experiences and Biomarkers of Well-being

Обзор

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).

Подробное описание

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.

Вмешательства

• Процедура 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, ant
• Процедура 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
• Процедура 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 ca

Первичные конечные точки

• 1-year changes in Social Experience [Срок оценки: Change from 4 weeks before surgery to 1 year after surgery]

Вторичные конечные точки (12)

• Changes in affect ratings after social evaluation (inclusion and exclusion) [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in experience ratings after social evaluation (inclusion and exclusion) [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in pleasantness ratings in response to touch stimulation on the forearm [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in pleasantness ratings in response to self-stroking on the forearm [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in intensity ratings in response to touch stimulation on the forearm [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in intensity ratings in response to self-stroking on the forearm [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in self-stroking velocity [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in cortisol levels from hair samples [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in endocannabinoid levels from hair samples [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in fasting ghrelin levels from blood samples [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in body image [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]
• Changes in reward responsivity [Срок оценки: Change from 4 weeks before surgery to 6 weeks and 1 year after surgery]

Критерии участия

Критерии включения

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

Критерии исключения

• pregnancy and breast-feeding
• chronic disease (endocrine, heart, neurological, lung, gastrointestinal, kidney)
• cancer
• acute psychotic episode

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Организация здравоохранения

Центры проведения

Норвегия · 1 центр

• Morbid Obesity Center — Tønsberg

Публикации

• Broadhead WE, Kaplan BH, James SA, Wagner EH, Schoenbach VJ, Grimson R, Heyden S, Tibblin G, Gehlbach SH. The epidemiologic evidence for a relationship between social support and health. Am J Epidemiol. 1983 May;117(5):521-37. doi: 10.1093/oxfordjournals.aje.a113575. No abstract available. PMID 6342368
• Uchino BN. Social support and health: a review of physiological processes potentially underlying links to disease outcomes. J Behav Med. 2006 Aug;29(4):377-87. doi: 10.1007/s10865-006-9056-5. Epub 2006 Jun 7. PMID 16758315
• Umberson D, Montez JK. Social relationships and health: a flashpoint for health policy. J Health Soc Behav. 2010;51 Suppl(Suppl):S54-66. doi: 10.1177/0022146510383501. PMID 20943583
• Maphis LE, Martz DM, Bergman SS, Curtin LA, Webb RM. Body size dissatisfaction and avoidance behavior: how gender, age, ethnicity, and relative clothing size predict what some won't try. Body Image. 2013 Jun;10(3):361-8. doi: 10.1016/j.bodyim.2013.02.003. Epub 2013 Mar 27. PMID 23540887
• Brytek-Matera A, Czepczor-Bernat K, Olejniczak D. Food-related behaviours among individuals with overweight/obesity and normal body weight. Nutr J. 2018 Oct 16;17(1):93. doi: 10.1186/s12937-018-0401-7. PMID 30326901
• Karlsson J, Taft C, Ryden A, Sjostrom L, Sullivan M. Ten-year trends in health-related quality of life after surgical and conventional treatment for severe obesity: the SOS intervention study. Int J Obes (Lond). 2007 Aug;31(8):1248-61. doi: 10.1038/sj.ijo.0803573. Epub 2007 Mar 13. PMID 17356530
• Coulman KD, MacKichan F, Blazeby JM, Owen-Smith A. Patient experiences of outcomes of bariatric surgery: a systematic review and qualitative synthesis. Obes Rev. 2017 May;18(5):547-559. doi: 10.1111/obr.12518. Epub 2017 Mar 8. PMID 28273694
• Pfabigan DM, Hertel JK, Svanevik M, Lindberg M, Sailer U, Hjelmesaeth J. Single-centre, non-randomised clinical trial at a tertiary care centre to investigate 1-year changes in social experiences and biomarkers of well-being after bariatric surgery in individuals with severe obesity: protocol for the Bariatric Surgery and Social Experiences (BaSES) study. BMJ Open. 2023 Aug 28;13(8):e071332. doi: PMID 37640458

Идентификаторы

NCT: NCT05207917 · 238406

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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