Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery

Obesity Clinical Trial

Official title:

Score Scale to Assess Risk of Bleeding in Bariatric Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03556995
• Other study ID #: 01-18
• Status: Completed
• Start date: January 1, 2013
• Est. completion date: January 31, 2018

Study information

• Verified date: June 2018
• Source: Assuta Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

As bleeding is a major risk in bariatric surgeries, we aimed our study to find any predictors to such bleeding within the surgery or 30 days after surgery. The study is a retrospective study collecting patients data, surgeons data, and hospitals data in order to find if any of the factors influencing patients, surgeons or hospitals, has to do with bleeding in these surgeries and if it does impact bleeding in what way. The goal is finding a predictor that it's neutralizing may prevent bleeding in bariatric surgeries.

Description:

Were collected retrospectively the data of all patients (age 18 and older) that underwent bariatric surgery in Assuta Hospitals (Assuta is a nationwide privet hospitals network), during the years 2013-2016.

Patients underwent one of three procedures:

• laparoscopic sleeve gastrectomy (LSG),

• laparoscopic gastrectomy by-pass (LGBP)

• laparoscopic adjustable gastric band (LAGB) Demographic data of patients was collected (age, gender. BMI, habits, smoking, alcohol consumption etc.), as well as medical history, background diseases, family medical history, previous surgeries and procedures, chronic treatments, use of medications etc., We have also collected surgeons and hospital data - in which hospital was the surgery done? Surgery technique, surgeon's experience, capacity of surgeon - how many bariatric surgeries are done by the surgeon per months? Statistical analyses was done using chi square and Fisher's exact test for analyzing specific single variables. When analyzing the possible connection between BMI and bleeding, BMI values were split into three categories 3040. The use of single variable analyses enabled us to focus on a relatively small number of variables in the multivariable analyses. Variables that were statistically significant (p<0.05) were used as independent variables in logistic regression tests.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9044
• Est. completion date: January 31, 2018
• Est. primary completion date: March 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:all patients that underwent bariatric surgery -

Exclusion Criteria: Under 18 years old

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Bleeding
• Complication
• Hemorrhage
• Obesity

Intervention

Other:
• bariatric surgery patients

Locations

Country	Name	City	State
Israel	Assuta MC	Tel Aviv

Sponsors (1)

Lead Sponsor	Collaborator
Assuta Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (11)

Adams TD, Davidson LE, Litwin SE, Kolotkin RL, LaMonte MJ, Pendleton RC, Strong MB, Vinik R, Wanner NA, Hopkins PN, Gress RE, Walker JM, Cloward TV, Nuttall RT, Hammoud A, Greenwood JL, Crosby RD, McKinlay R, Simper SC, Smith SC, Hunt SC. Health benefits — View Citation

Buchwald H, Oien DM. Metabolic/bariatric surgery worldwide 2011. Obes Surg. 2013 Apr;23(4):427-36. doi: 10.1007/s11695-012-0864-0. — View Citation

Colquitt JL, Pickett K, Loveman E, Frampton GK. Surgery for weight loss in adults. Cochrane Database Syst Rev. 2014 Aug 8;(8):CD003641. doi: 10.1002/14651858.CD003641.pub4. Review. — View Citation

Courcoulas AP, Christian NJ, Belle SH, Berk PD, Flum DR, Garcia L, Horlick M, Kalarchian MA, King WC, Mitchell JE, Patterson EJ, Pender JR, Pomp A, Pories WJ, Thirlby RC, Yanovski SZ, Wolfe BM; Longitudinal Assessment of Bariatric Surgery (LABS) Consortiu — View Citation

Daigle CR, Brethauer SA, Tu C, Petrick AT, Morton JM, Schauer PR, Aminian A. Which postoperative complications matter most after bariatric surgery? Prioritizing quality improvement efforts to improve national outcomes. Surg Obes Relat Dis. 2018 May;14(5): — View Citation

Fecso AB, Samuel T, Elnahas A, Sockalingam S, Jackson T, Quereshy F, Okrainec A. Clinical Indicators of Postoperative Bleeding in Bariatric Surgery. Surg Laparosc Endosc Percutan Tech. 2018 Feb;28(1):52-55. doi: 10.1097/SLE.0000000000000480. — View Citation

Nguyen NT, Paya M, Stevens CM, Mavandadi S, Zainabadi K, Wilson SE. The relationship between hospital volume and outcome in bariatric surgery at academic medical centers. Ann Surg. 2004 Oct;240(4):586-93; discussion 593-4. — View Citation

Nielsen AW, Helm MC, Kindel T, Higgins R, Lak K, Helmen ZM, Gould JC. Perioperative bleeding and blood transfusion are major risk factors for venous thromboembolism following bariatric surgery. Surg Endosc. 2018 May;32(5):2488-2495. doi: 10.1007/s00464-01 — View Citation

Nimeri AA, Bautista J, Ibrahim M, Philip R, Al Shaban T, Maasher A, Altinoz A. Mandatory Risk Assessment Reduces Venous Thromboembolism in Bariatric Surgery Patients. Obes Surg. 2018 Feb;28(2):541-547. doi: 10.1007/s11695-017-2909-x. — View Citation

Søvik TT, Aasheim ET, Taha O, Engström M, Fagerland MW, Björkman S, Kristinsson J, Birkeland KI, Mala T, Olbers T. Weight loss, cardiovascular risk factors, and quality of life after gastric bypass and duodenal switch: a randomized trial. Ann Intern Med. — View Citation

Suter M, Calmes JM, Paroz A, Giusti V. A 10-year experience with laparoscopic gastric banding for morbid obesity: high long-term complication and failure rates. Obes Surg. 2006 Jul;16(7):829-35. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	operative or postoperative bleeding complication	patients underwent any type of bariatric surgery in our medical network	30 days postoperative
Secondary	treatment of the complication	Treated conservatively, re operation, endoscopy	30 days postoperative