Denne siden ble automatisk oversatt og nøyaktigheten av oversettelsen er ikke garantert. Vennligst referer til engelsk versjon for en kildetekst.

Coffee Consumption After Laparoscopic Hysterectomy (COFFEE-LH)

6. juli 2026 oppdatert av: muzeyyen ataseven, Istanbul Medipol University Hospital

Effect of Postoperative Coffee Consumption on Bowel Motility and Length of Hospital Stay Following Laparoscopic Hysterectomy: A Randomized Controlled Trial

Postoperative ileus and delayed bowel recovery remain common concerns following laparoscopic hysterectomy despite enhanced recovery protocols. Coffee consumption has been suggested as a simple, safe, and inexpensive intervention that may stimulate gastrointestinal motility and accelerate postoperative recovery. This randomized controlled trial aims to evaluate the effect of postoperative coffee consumption on bowel function recovery and length of hospital stay in women undergoing laparoscopic hysterectomy. Eligible participants are randomly assigned to either a coffee intervention group receiving standard postoperative care plus coffee at predetermined postoperative time points or a control group receiving standard postoperative care alone. The primary objective is to determine whether postoperative coffee consumption improves bowel recovery and shortens hospitalization.

Studieoversikt

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

Intervensjonell

Registrering (Faktiske)

50

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Istanbul, Tyrkia (Türkiye), 34810
        • İstanbul Bağcılar Training and Research Hospital

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

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.
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.
Ingen inngripen: Control Group
Participants received standard postoperative care according to institutional clinical practice without postoperative coffee consumption.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
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.
Time from the end of surgery to the first passage of flatus, recorded in hours.
From the end of surgery until the first passage of flatus, assessed for up to 72 hours after surgery.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Time to First Defecation
Tidsramme: From the end of surgery until the first bowel movement, assessed for up to 72 hours after surgery.
Time from the end of surgery to the first bowel movement.
From the end of surgery until the first bowel movement, assessed for up to 72 hours after surgery.
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.
Time from the end of surgery to the first audible bowel sounds.
From the end of surgery until the first bowel sounds are detected, assessed for up to 72 hours after surgery.
Length of Hospital Stay
Tidsramme: From the date of surgery until hospital discharge, assessed for up to 5 days after surgery.
Duration of hospitalization from surgery until discharge.
From the date of surgery until hospital discharge, assessed for up to 5 days after surgery.

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Müzeyyen Ataseven, PhD,RN, Istanbul Medipol University, Faculty of Health Sciences

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

12. mai 2025

Primær fullføring (Faktiske)

25. oktober 2025

Studiet fullført (Faktiske)

25. oktober 2025

Datoer for studieregistrering

Først innsendt

29. juni 2026

Først innsendt som oppfylte QC-kriteriene

6. juli 2026

Først lagt ut (Faktiske)

7. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

7. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • LHCOFFEE2025

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

IPD-planbeskrivelse

Individual participant data (IPD) will not be shared. The study did not include a data-sharing plan, and participant confidentiality will be maintained.

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere