- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07686510
Coffee Consumption After Laparoscopic Hysterectomy (COFFEE-LH)
Effect of Postoperative Coffee Consumption on Bowel Motility and Length of Hospital Stay Following Laparoscopic Hysterectomy: A Randomized Controlled Trial
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
Laparoscopic hysterectomy is one of the most commonly performed minimally invasive gynecological procedures. Although enhanced recovery after surgery (ERAS) protocols have improved postoperative outcomes, delayed gastrointestinal recovery and postoperative ileus continue to affect patient recovery, comfort, and hospital length of stay.
Coffee contains several bioactive compounds that may stimulate gastrointestinal motility through multiple physiological mechanisms, including increased gastrin secretion, activation of the gastrocolic reflex, and enhanced colonic motor activity. Previous clinical studies have suggested that postoperative coffee consumption may accelerate bowel function recovery after abdominal surgery; however, evidence specific to laparoscopic hysterectomy remains limited.
This single-center, randomized controlled trial evaluates the effectiveness of postoperative coffee consumption in women undergoing laparoscopic hysterectomy. Fifty eligible participants are randomly allocated in a 1:1 ratio to either an intervention group or a control group using block randomization. Participants in the intervention group receive standard postoperative care together with 100 mL of soluble coffee prepared with hot water at postoperative hours 6, 12, and 18, whereas participants in the control group receive standard postoperative care alone.
The study evaluates postoperative bowel recovery by assessing bowel sounds, passage of flatus, passage of stool, abdominal distension, nausea, vomiting, distension-related pain, and length of hospital stay. The findings are expected to provide evidence regarding a simple, low-cost, and feasible nursing intervention that may improve postoperative recovery following laparoscopic hysterectomy.
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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-
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Istanbul, Tyrkia (Türkiye), 34810
- İstanbul Bağcılar Training and Research Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
Inclusion Criteria:
- Women aged 18 years or older.
- Scheduled for elective laparoscopic hysterectomy.
- Able to consume oral fluids according to the ERAS protocol.
- Able to communicate in Turkish.
- Willing to participate and provide written informed consent.
Exclusion Criteria:
- Emergency surgery.
- Known allergy or intolerance to coffee or caffeine.
- Gastrointestinal diseases or conditions affecting bowel motility.
- Postoperative complications requiring intensive care or preventing oral intake.
- Withdrawal of informed consent at any stage of the study.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Coffee Group
Participants received standard postoperative care plus 100 mL of soluble coffee prepared with hot water at postoperative 6, 12, and 18 hours.
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Participants received 100 mL of hot soluble coffee prepared with hot water at postoperative hours 6, 12, and 18 in addition to standard postoperative ERAS care.
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Ingen inngripen: Control Group
Participants received standard postoperative care according to institutional clinical practice without postoperative coffee consumption.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time to First Passage of Flatus
Tidsramme: From the end of surgery until the first passage of flatus, assessed for up to 72 hours after surgery.
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Time from the end of surgery to the first passage of flatus, recorded in hours.
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From the end of surgery until the first passage of flatus, assessed for up to 72 hours after surgery.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time to First Defecation
Tidsramme: From the end of surgery until the first bowel movement, assessed for up to 72 hours after surgery.
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Time from the end of surgery to the first bowel movement.
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From the end of surgery until the first bowel movement, assessed for up to 72 hours after surgery.
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Time to First Bowel Sounds
Tidsramme: From the end of surgery until the first bowel sounds are detected, assessed for up to 72 hours after surgery.
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Time from the end of surgery to the first audible bowel sounds.
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From the end of surgery until the first bowel sounds are detected, assessed for up to 72 hours after surgery.
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Length of Hospital Stay
Tidsramme: From the date of surgery until hospital discharge, assessed for up to 5 days after surgery.
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Duration of hospitalization from surgery until discharge.
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From the date of surgery until hospital discharge, assessed for up to 5 days after surgery.
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Samarbeidspartnere og etterforskere
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Müzeyyen Ataseven, PhD,RN, Istanbul Medipol University, Faculty of Health Sciences
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
Andre studie-ID-numre
- LHCOFFEE2025
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
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