Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:19 AM
Study NCT ID:
NCT07483957
Status:
COMPLETED
Last Update Posted:
2026-03-19
First Post:
2026-03-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Linear vs. Circular Stapled Gastrojejunal Anastomosis in Bariatric Laparoscopic Gastric Bypass Surgery in Switzerland
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21375}, 'targetDuration': '90 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-03-17', 'studyFirstSubmitDate': '2026-03-05', 'studyFirstSubmitQcDate': '2026-03-17', 'lastUpdatePostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall complications', 'timeFrame': 'Periprocedural'}], 'secondaryOutcomes': [{'measure': 'Individual complications', 'timeFrame': 'Periprocedural', 'description': 'International Statistical Classification of Diseases and Related Health Problems 10th Revision codes\n\nMyocardial 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'}, {'measure': 'Reoperation', 'timeFrame': 'Periprocedural', 'description': 'A reoperation was selected based on the Swiss Classification of Operations (CHOP) code 00.99.10.'}, {'measure': 'Length of hospital stay', 'timeFrame': 'up to 4 weeks', 'description': 'Length of hospital stay was assessed at the 50th percentile (typical postoperative course) and the 90th percentile (prolonged postoperative course).'}, {'measure': 'Time trend age', 'timeFrame': 'Between 2015 and 2022', 'description': 'Time trend of annual mean age (years)'}, {'measure': 'Time trend CCI', 'timeFrame': 'Between 2015 and 2022', 'description': 'Time trend of annual mean Charlson Comorbidity Index (CCI)'}, {'measure': 'Time trend insurance', 'timeFrame': 'Between 2015 and 2022', 'description': 'Time trend of annual percentage of private insurance'}, {'measure': 'Time trend access', 'timeFrame': 'Between 2015 and 2022', 'description': 'Time trend of annual percentage of robotic access'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Bariatric Surgery (Gastric Bypass)']}, 'descriptionModule': {'briefSummary': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients with gastric bypass surgery in Switzerland between 2015 and 2022', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective laparoscopic Roux-en-Y gastric bypass\n\nExclusion Criteria:\n\n* Incomplete documentation\n* Age under 20 years\n* Other hospitals than general or surgical hospitals\n* Omega-loop gastric bypass\n* Emergency admission\n* No stapler coded\n* Open access'}, 'identificationModule': {'nctId': 'NCT07483957', 'briefTitle': 'Linear vs. Circular Stapled Gastrojejunal Anastomosis in Bariatric Laparoscopic Gastric Bypass Surgery in Switzerland', 'organization': {'class': 'OTHER', 'fullName': 'Cantonal Hospital of St. Gallen'}, 'officialTitle': 'Linear vs. Circular Stapled Gastrojejunal Anastomosis in Bariatric Laparoscopic Gastric Bypass Surgery in Switzerland: A Retrospective National Registry Study From 2015 to 2022.', 'orgStudyIdInfo': {'id': 'RYGB linear vs. circular'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Linear', 'description': 'Elective laparoscopic Roux-en-Y gastric bypass with linear gastrojejunal anastomsis', 'interventionNames': ['Procedure: Linear anastomosis']}, {'label': 'Circular', 'description': 'Elective laparoscopic Roux-en-Y gastric bypass with circular gastrojejunal anastomsis', 'interventionNames': ['Procedure: Circular anastomosis']}], 'interventions': [{'name': 'Linear anastomosis', 'type': 'PROCEDURE', 'description': 'A linear stapled anastomosis was selected based on the Swiss Classification of Operations (CHOP) code 00.9A.13 or 00.9A.14.', 'armGroupLabels': ['Linear']}, {'name': 'Circular anastomosis', 'type': 'PROCEDURE', 'description': 'A circular stapled anastomosis was selected based on the Swiss Classification of Operations (CHOP) code 00.9A.11 or 00.9A.12.', 'armGroupLabels': ['Circular']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Sankt Gallen', 'country': 'Switzerland', 'facility': 'HOCH Health Ostschweiz, Kantonsspital St.Gallen', 'geoPoint': {'lat': 47.42391, 'lon': 9.37477}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cantonal Hospital of St. Gallen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Yanic Ammann', 'investigatorAffiliation': 'Cantonal Hospital of St. Gallen'}}}}