- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07483957
Linear vs. Circular Stapled Gastrojejunal Anastomosis in Bariatric Laparoscopic Gastric Bypass Surgery in Switzerland
Linear vs. Circular Stapled Gastrojejunal Anastomosis in Bariatric Laparoscopic Gastric Bypass Surgery in Switzerland: A Retrospective National Registry Study From 2015 to 2022.
Bariatric surgery has become one of the preferred options in treatment of severe obesity and its comorbidities in the Western world. In Switzerland, the approximate 5000 annual bariatric operations are performed exclusively in centres certified by the "Swiss Society of Study of Morbid Obesity and Metabolic Disorders (SMOB)". Among the different bariatric surgical procedures, the laparoscopic gastric bypass remains one of the most frequently performed operations. A critical step of this operation is the creation of the gastrojejunal anastomosis. This can be done using either a linear or a circular stapler. The optimal method continues to be discussed in current academic research. The linear anastomosis technique seems to be more feasible, uses smaller incisions and is therefore faster performed. The circular anastomosis technique benefits from a standardised diameter of the anastomosis with consecutive higher reproducibility. No difference in long-term weight loss have been described for these two techniques until today. The linear technique has been linked to marginal ulcers, while the circular technique has been associated with higher rates of stenosis and incisional hernia. The associations with other long-term adverse events such as internal hernias remain under discussion. However, according to several international analyses, the linear technique seems to have favourable short-term outcomes with shorter operation time and lower rates of wound complications and postoperative bleeding. Both techniques are used in Switzerland but Swiss national data on this topic is scarce. Given the high annual case volume of bariatric surgery in Switzerland and the inconsistent international evidence, a systematic comparison of these two techniques is of relevance.
This retrospective registry study provides Swiss national data on short-term postoperative outcomes after elective laparoscopic Roux-en-Y gastric bypass from 2015 to 2022. It aims to compare the linear vs. circular gastrojejunal anastomosis in terms of postoperative short-term postoperative, reoperation rate, and length of hospital stay.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
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Sankt Gallen, Switzerland, 9000
- HOCH Health Ostschweiz, Kantonsspital St.Gallen
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Elective laparoscopic Roux-en-Y gastric bypass
Exclusion Criteria:
- Incomplete documentation
- Age under 20 years
- Other hospitals than general or surgical hospitals
- Omega-loop gastric bypass
- Emergency admission
- No stapler coded
- Open access
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Linear
Elective laparoscopic Roux-en-Y gastric bypass with linear gastrojejunal anastomsis
|
A linear stapled anastomosis was selected based on the Swiss Classification of Operations (CHOP) code 00.9A.13 or 00.9A.14.
|
|
Circular
Elective laparoscopic Roux-en-Y gastric bypass with circular gastrojejunal anastomsis
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A circular stapled anastomosis was selected based on the Swiss Classification of Operations (CHOP) code 00.9A.11 or 00.9A.12.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Overall complications
Time Frame: Periprocedural
|
Periprocedural
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Individual complications
Time Frame: Periprocedural
|
International Statistical Classification of Diseases and Related Health Problems 10th Revision codes Myocardial infarction (I21, I22) I21, I22 Cardiac arrest I46 Arterial fibrillation I48 DVT and/or PE I26.0, I26.9, I80.2 Pneumonia J13-18, J85.1 Pleural effusion J90, J91 Atelectasis J98.1 Aspiration J69.0, J69.8, J95.4 Pulmonary insufficiency J95.1, J95.2, J95.3, J96 ARDS J80 Acute kidney injury N17, N19 Urinary tract infection N10, N30.0, N30.9, N39.0 Urinary retention R33 Anastomotic leakage K91.83 Gastrointestinal ulcer K25, K28 Peritonitis / abscess K65 Delayed gastric emptying K31.88 Ileus K56, K91.3 Bleeding K81.0, S36.81 Shock T81.1 Wound dehiscence T81.3 SSI T81.4, T89.02, L08.9 Intraoperative injury T81.2 Intraoperative retained foreign body T81.5, T81.6 Other complications J95.8, J95.9, K91.88, K91.9, T81.8, T81.9 |
Periprocedural
|
|
Reoperation
Time Frame: Periprocedural
|
A reoperation was selected based on the Swiss Classification of Operations (CHOP) code 00.99.10.
|
Periprocedural
|
|
Length of hospital stay
Time Frame: up to 4 weeks
|
Length of hospital stay was assessed at the 50th percentile (typical postoperative course) and the 90th percentile (prolonged postoperative course).
|
up to 4 weeks
|
|
Time trend age
Time Frame: Between 2015 and 2022
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Time trend of annual mean age (years)
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Between 2015 and 2022
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Time trend CCI
Time Frame: Between 2015 and 2022
|
Time trend of annual mean Charlson Comorbidity Index (CCI)
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Between 2015 and 2022
|
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Time trend insurance
Time Frame: Between 2015 and 2022
|
Time trend of annual percentage of private insurance
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Between 2015 and 2022
|
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Time trend access
Time Frame: Between 2015 and 2022
|
Time trend of annual percentage of robotic access
|
Between 2015 and 2022
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- RYGB linear vs. circular
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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