Complications: RevisionsMISS 2010

Bruce M. WolfeProfessor of Surgery

Oregon Health & Science University

2

Complications: Revisions

• Provider error– Large gastric pouch– Incomplete gastric division– Incorrect limbs

3

Complications: Revisions

• Patient and/or provider factors– Marginal ulcer– Stricture– Intestinal obstruction

4

Complications: Revisions

• Poor weight loss or regain– Anatomic factor

• Gastric pouch size• Dilated gastrojejunostomy• Gastrogastric fistula

– Patient factor• Operative anatomy as expected

5

Marginal Ulcer

• Evaluation– Endoscopy– UGI

• Intraoperative endoscopy– Define pouch– Confirm resection– Test anastomosis

• ± Vagotomy

6

Background

• Increase in prevalence of obesity1

– BMI>30 kg/m2

• Men: 33.3%• Women: 35.3%

• Increase in number of primary bariatric procedures2-3

– 1998: 12,775– 2008: 220,000

1. Ogden CL, et al. Gastroenterology 2007;132(6):2087-1022. Nguyen NT, Root J, Zainabadi K, et al. Arch Surg 2005;140(12):1198-2023. American Society for Metabolic and Bariatric Surgery

7

Background

• Revisional bariatric surgery– Indications:

• Side effects or complications of prior bariatric surgery• Inadequate weight loss

– Higher morbidity than with first time procedures

8

GSPH

Clinical Center

Data Coordinating Center

NIDDK / ORWH

OHSU/Legacy

UWashington/VMason

NRI/UND

UPMC

Columbia/Cornell

ECU

NIDDK/ORWH

Sacramento Bariatric

9

Aim

– To determine independent risk factors for adverse outcome in patients undergoing revisional bariatric surgery

– To compare the outcome between first-time and revisional bariatric cases

10

LABS-1Total 5069 patients/operations

5033 Primary, revisional or reversal operations

30 Second stage procedures6 Other secondary obesity procedures

3803 stapled bariatric procedures

1230 Adjustable gastric banding

3802 patients/operations

1 patient underwent 2 separate procedures: a revision followed by a reversal; The reversal was excluded from the analysis

3577 primary procedures 225 revision/reversal procedures

11

Data definitions

• Composite endpoint (CE)– Death– Deep venous thrombosis (DVT) or

venothromboembolism (VTE)– Re-intervention with percutaneous, endoscopic or

operative techniques– Failure to discharge within 30-days of surgery

12

Statistical Analysis• Characteristics across subgroups:

– Categorical variables:• Pearson’s chi-square test

– Continuous:• Kruskal-Wallis test

• 30-day adverse outcomes:– Fisher’s exact test

• Association between baseline patient characteristics and the odds of 30-day adverse outcome :– Multivariable generalized linear logistic regression models

13

Patient characteristics for revisional patients

Characteristic

Median Age 49 years

Age categories (years) n (%)

<30 10 (4)

30-39 38 (17)

40-49 65 (29)

50-59 92 (41)

60-64 13 (6)

65+ 7 (3)

14

Patient characteristics for revisional patients

Characteristic n (%)

Male 29 (13)

BMI (kg/m2)

<35 64 (29)

35-<40 38 (17)

40-<50 75 (34)

50-<60 36 (16)

60+ 11 (5)

Median BMI 41 kg/m2

15

ComorbiditiesMean, median comorbidities 1.4, 1

# co-morbidities n (%)

None 71(32)

1 or more 151 (68)

2 or more 87 (39)

3 or more 40 (18)

4 or more 20 (9)

16

Major comorbidities and medication use

Characteristic n (%)

Hypertension 103 (46)

Diabetes 46 (20)

History of DVT or PE

18 (8)

Sleep apnea 61 (27)

Ischemic heart disease

15 (7)

Narcotic use 63 (28)

Antidepressant 108 (48)

17

Prior Obesity or Foregut Surgery

Procedure n (%)

Gastric bypass 84 (38.0)

BPD 1 (0.5)

DS 11 (5.0)

Gastric banding 42 (19.0)

VBG 47 (21.3)

Sleeve 4 (7.7)

Prior foregut 17 (22.2)

18

Surgery PerformedProcedure n (%)

RYGB 146 (64.9)

BPD 2 (0.9)

DS 8 (3.6)

Banded RYGB 2 (0.9)

Sleeve 19 (8.4)

Other 48 (21.1)

19

Adverse outcomeEvent n (%)

Death 1 (0.4)

DVT/PE 4 (1.8)

Tracheal reintubation 5 (2.2)

Placement of percutaneous drain 3 (1.3)

Endoscopy 10 (4.4)

Abd reoperation 18 (8)

Composite event 34 (15.1)

20

Predictors of CE among revisional surgeries

Event OR (95% CI)

p Adjusted OR (95% CI)

p

Patient age (per year)

1.04 (0.999, 1.09)

0.054 1.04(0.995, 1.08)

0.08

History of DVTYes vs. No

4.09 (1.40, 11.92)

0.01 3.72(1.25, 11.1)

0.018

21

Revisional vs. Primary

Unadjusted Odds of CE is more than twice high for revisional surgeries

compared to primary surgeries (OR = 2.4, 95% CI 1.6-3.6)

22

Revisional vs. Primary

Adjusted for important comorbidities and other patient characteristics, odds of CE

was more than twice as high for revisional surgeries compared to primary surgeries

(OR = 2.3, 95% CI 1.5-3.8)

23

Conclusions

• Revisional bariatric surgery can be performed without substantial mortality but with a greater incidence of adverse outcome compared to primary surgery

24

AcknowledgmentsThis clinical study was a cooperative agreement funded by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). Grant numbers: DCC -U01 DK066557; Columbia-Presbyterian - U01-DK66667; University of Washington - U01-DK66568 (in collaboration with GCRC, Grant M01RR-00037); Neuropsychiatric Research Institute - U01-DK66471; East Carolina University – U01-DK66526; University of Pittsburgh Medical Center – U01-DK66585; Oregon Health & Science University – U01-DK66555.

The authors thank the LABS study participants for their contributions.