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ObesityNCT03556995

Suggesting Score Scale for Risk of Bleeding in Bariatric Surgery

An observational study of Obesity and Bariatric Surgery Candidate, run by Assuta Medical Center at 1 site in Israel.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Obesity, Bariatric Surgery Candidate, Complication
What is being tested?
bariatric surgery patients
How many people
9,044 participants
Where
1 siteIsrael
Study dates
1 Jan 2013to 31 Jan 2018
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

None listed.

Who cannot join

  • -

Trial locations and contacts

1 site in 1 country.

Israel1 site

  • Assuta MC

    Tel Aviv

Other trials in Israel

About this study

Official title: Score Scale to Assess Risk of Bleeding in Bariatric Surgery

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.

Read the detailed 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., Were 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 30<BMI<35, 35<BMI<40 and BMI>40. 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.
Being tested
bariatric surgery patients
Medical subject headings
Obesity, Hemorrhage

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • bariatric surgery patientsOther

Study groups in NCT03556995
Study groupRoleWhat they receive
Bariatric surgery patientsAll patients above 18 that underwent bariatric surgery
Receives: Other: bariatric surgery patients

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. operative or postoperative bleeding complication

    patients underwent any type of bariatric surgery in our medical network

    Measured: 30 days postoperative

Secondary outcomes (1)

  1. treatment of the complication

    Treated conservatively, re operation, endoscopy

    Measured: 30 days postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jun 2018
  2. Study start1 Jan 2013
  3. Primary completion31 Mar 2016
  4. Study completion31 Jan 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
9,044 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03556995
Sponsor's protocol ID
01-18
Status last verified
May 2026
First submitted
3 Jun 2018
Last updated
8 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No IPD sharing Data

Publications

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

    PubMed 23338049

  • 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.

    PubMed 21893621

  • 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.

    PubMed 22990271

  • 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.

    PubMed 24189773

  • 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.

    PubMed 16839478

  • 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.

    PubMed 29101558

  • 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.

    PubMed 29023333

  • 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.

    PubMed 29503096

  • 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.

    PubMed 15383786

  • 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.

    PubMed 28836135

  • 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.

    PubMed 25105982

  • Susmallian S, Babis I, Raziel A. Early Physiologic Derangements for Detection of Major Complications After Bariatric Surgery: A Multicenter Cohort Study. Obes Surg. 2026 Sep 25. doi: 10.1007/s11695-026-08914-9. Online ahead of print.

    PubMed 42786267

Questions about this trial

What is this clinical trial studying?

An observational study of Obesity and Bariatric Surgery Candidate, run by Assuta Medical Center at 1 site in Israel.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

operative or postoperative bleeding complication (time frame: 30 days postoperative). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03556995, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.

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