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

NCT05207917 | Enrolling By Invitation

• 1 other identifier: 238406
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

• 1-year changes in Social Experience

  10-item checklist assessing frequency and quality of daily social interactions (preprint in August 2025: https://osf.io/preprints/psyarxiv/6psar\_v2); 2 sub-scales: (1) Being with others, (2) Being alone; the diary will be filled in 14 days in a row at the end of the day. Scale (1) was designed to measure enjoyment of being with others and the duration of social contact (6 items, range: 4 to 62.4), higher values indicate more enjoyment and a higher frequency of social contact. Scale (2) was designed to measure enjoyment of being alone (3 items, range: -5 to 20), higher values here indicate more enjoyment of being alone. An additional item at the beginning of the checklists asks how many people the respondent has had social contact with during the day (5 categories).

  Change from 4 weeks before surgery to 1 year after surgery

Secondary Outcomes (22)

• Changes in affect ratings after social evaluation (inclusion and exclusion)

  Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

• Changes in experience ratings after social evaluation (inclusion and exclusion)

  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

  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

  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

  Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

Other Outcomes (12)

• Change in Body Mass Index (BMI)

  Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

• Change in weight

  Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

• Change in anthropometric measures

  Change from 4 weeks before surgery to 6 weeks and 1 year after surgery

Study Arms (3)

Gastric bypass

ACTIVE COMPARATOR

Gastric bypass

Procedure: Gastric bypass

Sleeve gastrectomy

ACTIVE COMPARATOR

Sleeve gastrectomy

Procedure: Sleeve gastrectomy

Single anastomosis sleeve ileal (SASI) bypass

EXPERIMENTAL

Exploratory small arm with a small number of particpants

Procedure: Single anastomosis sleeve ileal (SASI) bypass

Interventions

Gastric bypass 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.

Gastric bypass

Sleeve gastrectomy 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.

Sleeve gastrectomy

Single anastomosis sleeve ileal (SASI) bypass 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.

Single anastomosis sleeve ileal (SASI) bypass

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• The Hospital of Vestfold: lead
• University of Oslo: collaborator

Study Sites (1)

Morbid Obesity Center

Tønsberg, Vestfold, 3103, Norway

Location

Related Publications (8)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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: 10.1136/bmjopen-2022-071332.

  PMID: 37640458 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Gastric Bypass

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Bariatric Surgery; Bariatrics; Obesity Management; Therapeutics; Gastroenterostomy; Anastomosis, Surgical; Surgical Procedures, Operative; Digestive System Surgical Procedures

Study Officials

• Jøran Hjelmesæth, Professor

  The Hospital of Vestfold

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: 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

Study Record Dates

• First Submitted: December 8, 2021
• First Posted: January 26, 2022
• Study Start: May 12, 2022
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Time Frame: For at least 10 years after publication
• Access Criteria: All requests must be handled within the legal framework of Norway; non-commercial use of de-anonymized data

Locations

NO (1)