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Coffee Consumption After Laparoscopic Hysterectomy (COFFEE-LH)

6. juli 2026 opdateret af: 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.

Studieoversigt

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

Interventionel

Tilmelding (Faktiske)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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.
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 indgriben: Control Group
Participants received standard postoperative care according to institutional clinical practice without postoperative coffee consumption.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

12. maj 2025

Primær færdiggørelse (Faktiske)

25. oktober 2025

Studieafslutning (Faktiske)

25. oktober 2025

Datoer for studieregistrering

Først indsendt

29. juni 2026

Først indsendt, der opfyldte QC-kriterier

6. juli 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • LHCOFFEE2025

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Postoperative Coffee Consumption

3
Abonner