NCT03556995

Brief Summary

As bleeding is a major risk in bariatric surgeries, The study aimed 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,044

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2018

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 14, 2018

Completed
Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

3.2 years

First QC Date

June 3, 2018

Last Update Submit

May 5, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • operative or postoperative bleeding complication

    patients underwent any type of bariatric surgery in our medical network

    30 days postoperative

Secondary Outcomes (1)

  • treatment of the complication

    30 days postoperative

Study Arms (1)

Bariatric surgery patients

All patients above 18 that underwent bariatric surgery

Other: bariatric surgery patients

Interventions

Bariatric surgery patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients that underwent any bariatric surgery in Assuta medical network, composed by 4 hospital of High Volume of bariatric surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assuta MC

Tel Aviv, Israel

Location

Related Publications (11)

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

  • Sovik TT, Aasheim ET, Taha O, Engstrom M, Fagerland MW, Bjorkman 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. 2011 Sep 6;155(5):281-91. doi: 10.7326/0003-4819-155-5-201109060-00005.

  • 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 of gastric bypass surgery after 6 years. JAMA. 2012 Sep 19;308(11):1122-31. doi: 10.1001/2012.jama.11164.

  • 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) Consortium. Weight change and health outcomes at 3 years after bariatric surgery among individuals with severe obesity. JAMA. 2013 Dec 11;310(22):2416-25. doi: 10.1001/jama.2013.280928.

  • 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. doi: 10.1381/096089206777822359.

  • 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/s00464-017-5951-9. Epub 2017 Nov 3.

  • 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.

  • 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):652-657. doi: 10.1016/j.soard.2018.01.008. Epub 2018 Jan 12.

  • 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. doi: 10.1097/01.sla.0000140752.74893.24.

  • 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.

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

MeSH Terms

Conditions

ObesityHemorrhage

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of the department of general surgery

Study Record Dates

First Submitted

June 3, 2018

First Posted

June 14, 2018

Study Start

January 1, 2013

Primary Completion

March 31, 2016

Study Completion

January 31, 2018

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

No IPD sharing Data

Locations