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OpenTrials
Completed

NCT Number: NCT01862159

Risk Factors Predicting Serious Complications With Laparoscopic Gastric Bypass Surgery

The rate of serious complications are relatively low in bariatric surgery today, but still 3-4 % will suffer from a serious complication. There are factors known before the surgery or during the operation that are likely to increase the risk for a serious complication. If the investigators are aware of these we can optimize the patients risk factors prior to the operation or at least increase the awareness of the increased risk in some patients given the presence of risk factors.

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Key information

Conditions

Postoperative Complications Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University Hospital Örebro

Örebro, 70185, Sweden

About this study

Data is collected prospectively to the Scandinavian Obesity Surgery Registry. Today all 44 clinics performing bariatric surgery in Sweden submits data on baseline characteristics, operational data and data from a 30 days, 1 year, 2 years and 5 years follow up for all patients. The database is compared annually to the Swedish civil registry to cover all mortality.

From the database we will identify patients who underwent a bariatric procedure between May 1st 2007 and September 30th 2012. Patients undergoing other bariatric procedures than laparoscopic gastric bypass or revisional surgery will be excluded.

The data will be analyzed with "Chi-2" test, logarithmic regression, linear regression or t-test when appropriate. Odds ratio will be calculated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Undergoing laparoscopic gastric bypass surgery and included in the Scandinavian Obesity Surgery Registry

Exclusion criteria

Undergoing other bariatric procedure than laparoscopic gastric bypass. Revisional surgery is excluded.

Lost to follow up.

Treatment and study plan

laparoscopic gastric bypass surgery

Procedure

laparoscopic gastric bypass surgery

Primary outcomes

  1. Serious Complications

    Time frame: 30 days or the postoperative hospital stay if longer than 30 days

    Graded as Clavien 3b or more (for patients entered in the registry after January 1st 2010)

Secondary outcomes

  1. Operating Time

    Time frame: operation

    length of the operation

  2. Length of Stay

    Time frame: 30 days or the postoperative hospital stay if longer than 30 days

    Length of stay after the primary operation

  3. Specific Postoperative Complications

    Time frame: 30 days or the postoperative hospital stay if longer than 30 days

    Any complication (Anastomotic leakage/abscesses, bleeding, small bowel obstruction, stomal ulcera, cardiovascular complications, pulmonary complications, venous thromboembolism, port site complication, other complication)

Sponsors and collaborators

Lead sponsor

Region Örebro County

Other

Collaborators

  • Scandinavian Obesity Surgery Registry

Registry information

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
May 24, 2013
Registry last updated
Aug 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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