- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg 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
Studieoversigt
Status
Intervention / Behandling
Detaljeret 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.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Istanbul, Tyrkiet (Türkiye), 34810
- Istanbul Bağcılar Training and Research Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde 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 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: 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 indgriben: Control Group
Participants received standard postoperative care according to institutional clinical practice without postoperative coffee consumption.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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 |
Foranstaltningsbeskrivelse |
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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Samarbejdspartnere og efterforskere
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Müzeyyen Ataseven, PhD,RN, Istanbul Medipol University, Faculty of Health Sciences
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
Andre undersøgelses-id-numre
- LHCOFFEE2025
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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