Effect of Omentopexy on Incisura Angularis Morphology and Gastric Emptying After Laparoscopic Sleeve Gastrectomy
Studieoversikt
Status
Forhold
Detaljert 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.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Ankara
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Ankara, Ankara, Tyrkia (Türkiye), 06100
- Ankara University Faculty of Medicine
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske 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 studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Volkan Genç, MD, Ankara University Faculty of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2023000352-2
Plan for individuelle deltakerdata (IPD)
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