- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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
Panoramica dello studio
Stato
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Istanbul, Turchia (Türkiye), 34810
- Istanbul Bağcılar Training and Research Hospital
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: Control Group
Participants received standard postoperative care according to institutional clinical practice without postoperative coffee consumption.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time to First Passage of Flatus
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Time to First Defecation
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Müzeyyen Ataseven, PhD,RN, Istanbul Medipol University, Faculty of Health Sciences
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- LHCOFFEE2025
Piano per i dati dei singoli partecipanti (IPD)
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Descrizione del piano IPD
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .