- ICH GCP
- US Clinical Trials Registry
- Clinical Trial 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
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Istanbul, Turkey (Türkiye), 34810
- Istanbul Bağcılar Training and Research Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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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No Intervention: Control Group
Participants received standard postoperative care according to institutional clinical practice without postoperative coffee consumption.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Passage of Flatus
Time Frame: 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.
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From the end of surgery until the first passage of flatus, assessed for up to 72 hours after surgery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to First Defecation
Time Frame: 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.
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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
Time Frame: 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.
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From the end of surgery until the first bowel sounds are detected, assessed for up to 72 hours after surgery.
|
|
Length of Hospital Stay
Time Frame: From the date of surgery until hospital discharge, assessed for up to 5 days after surgery.
|
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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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Müzeyyen Ataseven, PhD,RN, Istanbul Medipol University, Faculty of Health Sciences
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LHCOFFEE2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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