Effect of Omentopexy on Incisura Angularis Morphology and Gastric Emptying After Laparoscopic Sleeve Gastrectomy
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
Laparoscopic sleeve gastrectomy (LSG) is one of the most commonly performed bariatric surgical procedures worldwide. However, postoperative gastrointestinal symptoms, gastric torsion, and functional stenosis remain important concerns after surgery. Omentopexy has been proposed as a technical modification to stabilize the gastric tube and preserve anatomical alignment, but its clinical and functional effects remain controversial.
This prospective randomized controlled study was conducted to evaluate the effect of omentopexy performed during LSG on incisura angularis morphology, gastric emptying time, postoperative dyspeptic symptoms, and early weight loss outcomes. Eligible patients undergoing primary LSG were randomized into two groups: LSG with omentopexy and LSG without omentopexy.
The incisura angularis angle was evaluated using intraoperative image analysis. Gastric emptying time was assessed preoperatively and at the postoperative third month using scintigraphic gastric emptying studies (T½). Postoperative dyspeptic symptoms were evaluated using the Short Form Leeds Dyspepsia Questionnaire. Demographic, clinical, laboratory, and postoperative outcome data were prospectively recorded and compared between groups.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Ankara
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Ankara, Ankara, Tyrkiet (Türkiye), 06100
- Ankara University Faculty of Medicine
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
- Patients aged between 18 and 65 years Patients scheduled for primary laparoscopic sleeve gastrectomy for obesity treatment Patients who provided written informed consent
Exclusion Criteria:
- Previous gastrointestinal surgery Hiatal hernia Peptic ulcer disease Esophagitis Pangastritis detected on preoperative endoscopy Inability to tolerate postoperative scintigraphic evaluation
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: LSG With Omentopexy
Participants underwent laparoscopic sleeve gastrectomy with omentopexy.
Omentopexy was performed by fixation of the greater omentum to the gastric staple line following sleeve gastrectomy.
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Laparoscopic sleeve gastrectomy was performed using a standard surgical technique.
In addition, omentopexy was performed by fixation of the greater omentum to the gastric staple line in order to stabilize the gastric tube anatomy.
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Aktiv komparator: LSG Without Omentopexy
Participants underwent standard laparoscopic sleeve gastrectomy without omentopexy.
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Standard laparoscopic sleeve gastrectomy was performed without omentopexy.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Change in Incisura Angularis Angle
Tidsramme: Preoperative and postoperative 3 months
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Changes in the incisura angularis angle were evaluated using vector-based measurements obtained from intraoperative images before and after laparoscopic sleeve gastrectomy.
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Preoperative and postoperative 3 months
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Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Volkan Genç, MD, Ankara University Faculty of Medicine
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2023000352-2
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
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Kliniske forsøg med Laparoscopic Sleeve Gastrectomy With Omentopexy
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Unidad Internacional de Cirugia Bariatrica y MetabolicaRekruttering