NCT07686510

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 12, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 7, 2026

Completed
Last Updated

July 7, 2026

Status Verified

July 1, 2026

Enrollment Period

6 months

First QC Date

June 29, 2026

Last Update Submit

July 6, 2026

Conditions

Keywords

Laparoscopic HysterectomyCoffeeERASNursing InterventionPostoperative Recovery

Outcome Measures

Primary Outcomes (1)

  • Time to First Passage of Flatus

    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.

Secondary Outcomes (3)

  • Time to First Defecation

    From the end of surgery until the first bowel movement, assessed for up to 72 hours after surgery.

  • Time to First 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

    From the date of surgery until hospital discharge, assessed for up to 5 days after surgery.

Study Arms (2)

Coffee Group

EXPERIMENTAL

Participants received standard postoperative care plus 100 mL of soluble coffee prepared with hot water at postoperative 6, 12, and 18 hours.

Behavioral: Postoperative Coffee Consumption

Control Group

NO INTERVENTION

Participants received standard postoperative care according to institutional clinical practice without postoperative coffee consumption.

Interventions

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.

Coffee Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Bağcılar Training and Research Hospital

Istanbul, 34810, Turkey (Türkiye)

Location

Study Officials

  • Müzeyyen Ataseven, PhD,RN

    Istanbul Medipol University, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The outcomes assessor/statistician who performed the data analysis was blinded to group allocation.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were randomly assigned in a 1:1 ratio to either the intervention or control group using block randomization. The intervention group received postoperative coffee in addition to standard postoperative care, whereas the control group received standard postoperative care alone.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, RN, Principal Investigator

Study Record Dates

First Submitted

June 29, 2026

First Posted

July 7, 2026

Study Start

May 12, 2025

Primary Completion

October 25, 2025

Study Completion

October 25, 2025

Last Updated

July 7, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

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

Locations