Description of the population
A total of 119 non-responders were assessed. Fifteen patients were excluded, either for having a banded RYGB (n=9 or an OAGB/MGB (n=2), or because they did not receive RYGB or SG but a different procedure (Laparoscopic Adjustable Gastric Banding, LAGB n=3, BPD n=1). In total, 104 patients were included in the study. The group of 1NR consisted of 15 patients and the group of 2NR consisted of 89 patients (table 1). In the group of 2NR, 19 patients received an individual treatment, while in the group of 1NR none of the patients received an individual treatment. Moreover, 40% of the patients with 1NR had a history of gastric banding, while only 16% had this history in the group of 2NR.
Table 1. Baseline characteristics of the study population
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Total n=104
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1NR n=15
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2NR n=89
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Gender, no. (%) Female Male
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92 (88.5) 12 (11.5)
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11 (73.3) 4 (26.7)
|
81 (91.0)
8 (9.0)
|
Age# (years)1
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44.2±9.8 (27-69)
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44.4±10.6 (23-69)
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44.2±9.7 (27-66)
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Preoperative comorbidities, no. (%) Hypertension Type II diabetes
Dyslipidaemia OSAS Osteoarthritis
|
20 (19.2) 9 (8.7) 5 (4.8) 10 (9.6) 7 (6.7)
|
2 (13.3) - 1 (6.7)
2 (13.3) -
|
18 (20.0)
9 (10.1)
4 (4.5)
8 (9.0)
7 (7.9)
|
Comorbidities, no. (%) Unchanged
Disappeared Recurrence
|
18 (17.3) 19 (18.3) 4 (3.8)
|
1 (6.7)
1 (6.7)
1 (6.7)
|
17 (19.1)
18 (20.2)
3 (3.4)
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Preoperative individual treatment, no. (%)
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19 (18.3)
|
-
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19 (21.3)
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History of bariatric surgery, no. (%) LAGB Mason
SG
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20 (19.2) 6 (5.8) 6 (5.8)
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6 (40.0)
2 (13.3)
4 (26.7)
|
14 (15.7) 4 (4.5) 2 (2.2)
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Index procedure, no. (%) RYGB SG Laparoscopic
Laparotomy
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93 (89.4) 11 (10.6) 99 (95.2) 5 (4.8)
|
14 (93.3)
1 (6.7)
14 (93.3) 1 (6.7)
|
79 (88.8)
10 (11.2)
85 (95.5) 4 (4.5)
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Complications, no. (%) No complications Clavien-Dindo grade I Clavien-Dindo grade II
Clavien-Dindo grade III
|
92 (88.5)
2 (1.9) 3 (2.9) 7 (6.7)
|
15 (100.0)
-
-
-
|
77 (86.5)
2 (2.2) 3 (3.4) 7 (7.9)
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Interval to presentation (years)2
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4 (3-6)
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5 (3-7)
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4 (3-5)
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Preoperative weight (kg)1
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130.9±23.5 (94-231)
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135.8±29.7 (102-188)
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130.1±22.4 (94-231)
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Preoperative BMI (kg/m2)2
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43.6 (40.8-48.4)
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47.4 (36.2-53.5)
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43.5 (41.1-47.9)
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Maximal EWL (%)1
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75.9±24.3 (9-127)
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37.7±10.8 (9-48)
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82.4±19.4 (50-127)
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Maximal TWL (%)1
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32.6±10.1 (3-52)
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16.6±6.6 (3-27)
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35.3±7.9 (19-52)
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Weight regain (%)2
|
20.3 (14.1-30.9)
|
12.4 (8.0-18.0)
|
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# Age at time of MDT meeting
1 Expressed in mean ±SD (range): 2 Expressed in median (IQR 25-75)
List of abbreviations: MDT= Multidisciplinary Team, OSAS= Obstructive Sleep Apnoea Syndrome, BMI= Body Mass Index, LAGB= Laparoscopic Adjustable Gastric Banding, RYGB= Roux-en-Y Gastric bypass, SG= Sleeve Gastrectomy, EWL= Excess Weight Loss, TWL= Total Weight Loss, SD= Standard Deviation, IQR= Interquartile Range.
Data presented as number (%), mean (standard deviation) or median (interquartile range)
Description of given treatment
Prior to the multidisciplinary team meeting, 98% was referred to a dietician, 97% was referred to a physical therapist and 28% was referred to a medical psychologist (table 2; figure 2). Twenty patients (19%) did not show up at the appointment with the dietician and/or physical therapist and/or medical psychologist. Therefore, no optimal treatment could be advised and consequently these patients were excluded from further analysis. In total, 87% received a conservative treatment and 13% an operative treatment. When focusing on the conservative treatment, 86% received a nutritional intervention, 63% received a physical intervention and 25% received a behavioral intervention.
Table 2. Overview of given treatment in non-responders
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Total n=104
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1NR n=15
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2NR n=89
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Referred patients Dietician Physical therapist Medical psychologist
|
102 (98.1)
101 (97.1)
29 (27.9)
|
15 (100.0) 15 (100.0) 6 (40.0)
|
87 (97.8) 86 (96.6) 23 (25.8)
|
No show
|
20 (19.2)
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3 (20.0)
|
17 (19.1)
|
|
Subtotal n=84
|
1NR n=12
|
2NR n=72
|
Operative treatment, no. Alternation of the limb length Revision of the gastric pouch and/or stoma RYGB
Ring placement
|
11
3 (27.3)
7 (63.6) 2 (18.2) 1 (9.1)
|
-
-
-
-
-
|
11
3 (27.3)
7 (63.6) 2 (18.2) 1 (9.1)
|
Conservative treatment, no.
Nutritional intervention
Physical intervention
Behavioral intervention
Referred to psychiatric institution
|
73 63 (86.3) 46 (63.0) 18 (24.7) 4 (5.5)
|
12
53 (86.9)
39 (63.9)
14 (23.0)
2 (3.3)
|
61 10 (83.3)
7 (58.3)
4 (33.3)
2 (16.7)
|
Data presented as number (%)
Weight loss outcomes
Table 3 displays the effect on weight loss within 12 months and 24 months after start of the treatment. As a result of conservative treatment, patients with 1NR lost 1.2kg within 12 months (SD=4.3) and 2.8kg within 24 months (SD=2.7). Patients with 2NR lost 2.4kg within 12 months (SD=7.8) and 0.4kg within 24 months (SD=5.4). These results did not reach significance compared to their baseline weight. Additional analysis showed that within the group of conservatively treated patients with 2NR 49% did not gain any more weight or lost weight, while 51% gained weight within 24 months. The results of the surgically treated patients with 2NR are more pronounced. On average, these patients lost 12.0kg within 12 months (SD=10.8) and 26.3kg within 24 months (SD=1.1). The weight loss within 12 and 24 months was statistically significant (p<0.05). In conservatively treated patients, weight loss outcomes were missing in 43% of patients within 12 months and in 77% of patients within 24 months, while in the surgically treated patients this was 18% and 82%.
Table 3. Effect of conservative and operative treatment on weight loss outcomes in non-responders
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Weight at start of treatment (kg) mean, ±SD
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∆Weight ≤ 12 months
|
∆Weight ≤ 24 months
|
n
|
mean kg ±SD
|
p value
|
N
|
mean kg ±SD
|
p value
|
Conservative treatment
Total Primary non-response (1NR) Secondary non-response (2NR)
|
106.2 ±21.5 128.7 ±25.0 101.9 ±17.9
|
42 7
35
|
- 2.1 ±7.3 - 1.2 ±4.3
- 2.4 ±7.8
|
.06 .48 .08
|
17 3
14
|
- 0.8 ±5.1 - 2.8 ±2.7 - 0.4 ±5.4
|
.49 .21 .77
|
Surgical treatment Secondary non-response (2NR)
|
115.6 ±17.9
|
9
|
- 12.0 ±10.8
|
.01*
|
2
|
- 26.3 ±1.1
|
.02*
|
* Paired t-test: significant difference compared to the initial weight, p<0.05
The results were recalculated in %TWL. When using ≥15% TWL as a cut-off point for successful weight loss, six patients were categorized as 1NR and 98 patients as 2NR. This gives an enlargement of the group of the 2NR without affecting weight loss outcomes (conservatively treated patients lost -2.4kg <12 months SD=7.6 and -1.7kg <24 months SD=5.4, data not shown).
Description of operative treatment
Eleven patients were selected for operative treatment since no major nutritional-, physical-, or behavioral changes were identified. These re-operated patients were all categorized as 2NR. The index procedure was RYGB in 9 patients and SG in 2 patients. Four different surgical procedures were performed in these patients which are described in table 2. In detail, 2 patients with prior SG underwent conversion to RYGB; 3 patients with perioperative common limb lengths between 440-600cm underwent shortening of this common limb; 7 patients with a perioperative large pouch and/or stoma underwent resizing; 1 patient additionally received a gastric ring. Postoperative, one complication occurred in a patient with a history of gastric banding, followed by RYGB and subsequent alteration of the limb length. This patient developed, one year after alteration, an ulcerative stenosis at the gastroenterostomy treated with endoscopic dilatation.