SLEEVEPASS: A randomized prospective study ... - Obesitasdagar

Gastric bypass vs. Sleeve gastrectomy
SLEEVEPASS-study
Sleeve gastrectomy
Paulina Salminen, M.D., PhD
Turku University Hospital
Department of Surgery
Stockholms Obesitasdagar
19.4.2012

Swedish
Obese
Subjects
SOS
Percent weight change over 15 years
Weight change, %
0
-10
-20
Control
Banding
VBG
-30
Gastric
bypass
0 1 2 3 4 6 8 10 15
Years of follow up
Sjöström L et al. N Engl J Med 2007; 357: 741-52.

Bariatric surgery in Finland 2006 - 2012
• 2006: 99 operations
• 2007: 154 operations
• 2008: 430 operations
– RYGB 270, SG 150, LGB < 10
• 2009: 666 operations
– RYGB 472, SG 187, LGB 7
• 2010: 769 operations
• 2011: 1056 operations
– RYGB 919, SG 134, LGB 2, DS 1
• 2010 registered association
– FOTEG (Finnish(
Obesity Treatment Expert Group)
– www.foteg.fi

Long-term PROS for sleeve
gastrectomy
• NO internal hernias
NO bowel
obstruction
• NO malabsorption
• NO excluded
segments
• An intact gi-tract

SLEEVEPASS studygroup
• Turku University
Hospital
– Paulina Salminen, Mika
Helmiö, Jari Ovaska
• Vaasa Central Hospital
– Pipsa Peromaa, Mikael
Victorzon
• Peijas Hospital, Helsinki
– Anne Juuti, Marja
Leivonen

Study hypothesis
• “As sleeve gastrectomy is less traumatic,
easier and faster to perform compared
with gastric bypass, LSG could become
the procedure of choice to treat morbid
obesity if the long-term results of weight
loss and resolution of comorbidities are
comparable with laparoscopic gastric
bypass.”
• www.clinicaltrials.gov NCT 00793143
• Patient enrollment and operative treatment
April 2008 – June 2010

Inclusion criteria
• BMI 40 or BMI 35 and a
significant co-morbidity associated
with morbid obesity
• Age 18 – 60 years
• Previous successfully instituted and
supervised but failed adequate diet
and exercise program

Exclusion criteria
• BMI > 60
• Age > 60 or < 18
• Significant psychiatric disorder
• Severe eating disorder
• Active alcohol / substance abuse
• Active gastric ulcer disease
• Difficult GERD with a large hiatal hernia
• Previous bariatric surgery

Preoperative evaluation
• Multidisciplinary evaluation
• Upper gastrointestinal endoscopy
– Small hiatal hernia: SLEEVE 19.8 %, BYPASS
21.8 %
– Helicobacter pylori: SLEEVE 18.6 %, BYPASS
17.1 %
• Ultrasound examination
– Gallstones: SLEEVE 22.9 %, BYPASS 25.3 %

Operative technique / RYGB
• A small gastric pouch (20 – 40
ml)
• Biliopancreatic limb 50 – 80 cm
• Antecolic gastrojejunostomy
– Linear (45 mm) n = 56
– Circular (OrVil 25 mm) n = 59
• Alimentary limb 150 cm
• Jejunojejunostomy
– Closure: running suture /
totally stapled technique
• NO routine closure of
mesenteric defects
• Methylene blue test for
gastrojejunostomy

Operative technique / SG
• Calibration bougie 33 –
35 Fr
• 1st resection 4 – 6 cm
proximal to the pylorus
• 2 x green-load firings, ~
4 x blue-load firings
• Resection followed by
mobilization of the
stomach
• Methylene blue test 2/3
centers

• Patient demographics (p = ns)
– Age: median 49 years (range 23 – 67
years)
– 70 % , 30 %
– Preoperative BMI: median 44.6 kg/m²
(range 35 – 66 kg/m²)

SLEEVEPASS CONSORT 30-day
flowchart

SLEEVEPASS: Operation time and
hospitalization
SLEEVE BYPASS p-value
Mean operation
time (min)
66 min
(40 – 188 min)
94 min
(52 – 195 min)

SLEEVEPASS: Complications SG vs.
RYGB – 30-day morbidity
• Minor
– = all other postoperative complications
– SG 7.4 % vs. RYGB 17.1. % (p = 0.023)
• Major
– = reoperation, hospital stay > 7 days, need for blood transfusions > 4
units
– SG 5.8 % vs. RYGB 9.4 % (p = 0.292)

SLEEVEPASS: Complications SG vs.
RYGB – 30-day morbidity
• Minor
– = all other postoperative complications
– SG 7.4 % vs. RYGB 17.1. % (p = 0.023)
• Major
– = reoperation, hospital stay > 7 days, need for blood transfusions > 4
units
– SG 5.8 % vs. RYGB 9.4 % (p = 0.292)

SLEEVEPASS: Complications SG vs.
RYGB – 30-day morbidity
• Mortality 0 %
• Overall morbidity
– SG 16.2 % vs RYGB 26.5 % (p = 0.010)

SLEEVEPASS SG Reoperations, p = ns
SLEEVE
• Five reoperations (4.1 %) on three patients
• Patient 1
– Arterial bleeding laparotomy on the operation
day
• Patient 2
– Bleeding re-laparoscopy on the 1st postop.
day
• Patient 3
– Bleeding re-laparoscopy on the 1st postop.
day
– Small bowel perforation re-laparoscopy at two
weeks laparotomy + bowel resection

SLEEVEPASS RYGB Reoperations
BYPASS
• Six reoperations (5.1 %) on four patients
• Patient 1
– Bleeding re-laparoscopy on the operation day
• Patient 2
– Bleeding re-laparoscopy on the 1st postop. day
• Patient 3
– Torsion of the enteroanastomosis laparotomy on
the 5th postop. day
• Patient 4
– Bleeding re-laparoscopy on the 7th postop. day
laparotomy on the 14th postop. day angiography
and coiling of the pseudoaneurysm on the 17th
postop.day

• 123 papers, 12 129 patients

• 12 months mean EWL
– SG 56 % vs. RYGB
68 % (p < 0.01)
– 17 SG studies, 12
RYGB studies
• 24 months mean EWL
– SG 61 % vs. RYGB
70 % (p = 0.09)
– 7 SG studies, 10
RYGB studies

• 5-year follow-up:64 patients / 12 129 patients (0,5 %)

• 11/2001 – 8 / 2002, n = 53
• 6-year follow-up stand-alone SG
– 30 / 41 patients, telephone
questionnaire
– EWL 53 % vs. 78 % at 3-year
follow-up
– New GERD complaints in 21 %
• 11 patients underwent DS
– EWL 57 % vs. 73 % at 3-year
follow-up
Ann Surg 2010;252: 319-324

• 34-Fr bougie ”to guide the gastric division” vs.
to calibrate a more narrow sleeve?
• Follow-up visits?
• Post-SG GERD?

• Group A: no calibration
• Group B: 44 Fr
• Group C: 32 Fr
• B & C (!) higher %EWL

• n = 26
• 5-year mean EWL 55 %
• 15 % converted to RYGB
– Weight loss failure n = 3
– Severe reflux n = 1
• 31 % (n = 8) required daily PPI

• Mean preoperative BMI 39.3 kg/m²
• At median follow-up of ~ 4 years mean
EWL 72.3 % (n = 83 / 102 patients) vs. EWL
55.9 % at 6-year follow-up (23 patients)

• Mean preoperative
BMI 36.9 kg/m²,
mean age 37 years
• n = 773
• EWL at 3-year
follow-up 84.5 %
• Leakage rate 0.7 %
• Stenosis 0.1 %
• GERD 0.7 %

• Collective experience of > 12 000 SG
• Achieving consensus 70 % agreement
• No consensus < 70 % agreement

SG technique consensus
Rosenthal et al. Soard 2012;8: 8-19
• Bougie!
• Antrum / green loads
• Transsection 2 – 6 cm from pylorus
• Last firing AWAY from the GE junction!
• Complete mobilization of the fundus
• The use of staple line reinforcement

SG and GERD
Rosenthal et al. Soard 2012;8: 8-19
• Preoperative
evaluation
• Hiatoplasty and SG?

RYGB vs. SG: Weight regain?
SOS
Percent weight change over 15 years
Weight change, %
0
-10
-20
Control
Banding
VBG
-30
Gastric
bypass
0 1 2 3 4 6 8 10 15
Years of follow up
Sjöström L et al. N Engl J Med 2007; 357: 741-52. Himpens et al. Ann Surg 2010;252:319-324

In conclusion SG 2012
• SG a valid stand-alone
procedure
• Technical aspects
• Long-term follow-up is
required
• Patient selection
• GERD? (postoperative
incidence 0.7 % – 31 %)

In conclusion RCT: SLEEVEPASS
• At 30-day analysis SG is associated with a
shorter operation time and fewer early
complications
• At 6-month follow-up SG and RYGB have
similar %EWL, resolution of co-morbidities
and morbidity rate
• Long-term follow-up is required to
determine the effect of sleeve gastrectomy
on weight loss and resolution of obesity
related co-morbidities compared with RYGB
• SLEEVEPASS-trial follow-up will be
continued up to 15 years

Thank You!