>The Purpose of This Study Was to Determine Whether Consuming a 100-mL Cup of Coffee is Effective in Preventing or Reducing Postoperative Ileus After Laparotomy of Benign Gynecological Patients

The Effects of Coffee Ingestion on Recovery of Bowel Function in Patients Undergoing Benign Gynecologic Operation : A Randomized Controlled Trial

Comparison of the effectiveness coffee (with or without caffeine) ingestion and water for reducing the duration of Postoperative ileus after Laparotomy of Benign Gynecological Patients

Study Overview

• Status: Completed
• Conditions: Effects of Coffee Ingestion on Recovery of Bowel Function
• Intervention / Treatment: Other: caffeine coffee; Other: decaffiene coffee; Other: still water

Detailed Description

laparotomy benign gynecological surgery is the most common gynecologic operation worldwide because is major operation for surgery and can affect to bowel movement after operation and turn to postoperative ileus , clinically severe postoperative ileus affects up to 14% of patients after laparotomy for gynecologic surgery that leaded to more complication, slowly recovery , prolong length of hospitalized stay and consequently increase unnecessary cost of treatment.

Preclinical studies has considered to use preventative therapeutic options for prevent ileus including coffee

The investigators used the coffee reduces postoperative ileus However, no good quality of evidence base supports the effectiveness coffee (with or without caffeine) ingestion and water for reducing the duration of Postoperative ileus after Laparotomy of Benign Gynecological Patients

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Thailand
  • Bangkok
    • Phaya Thai, Bangkok, Thailand, 10400
      • Rajavithi Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Patients were asked to participate if they were scheduled to undergo laparotomy for a benign gynecologic condition
• Ever drink coffee before
• can speak or communication Thai language

Exclusion Criteria:

1 hypersensitivity or allergy to caffeine/ coffee 2.ever intraabdominal sugery before 3. had an active intra-abdominal malignancy, bowel perforation, pre-existing bowel disease, or a history of abdominal or pelvic irradiation.

4.pregnancy woman 5.thyroid disease 6 Inflammatory bowel disease 7.liver disease 8.cardiac arrhythmia 9.history of difficult to defecation ( feces only 2 times per week) 10.after operation need to stay in ICU more than 24 hr 11.need to put Ng tube after operation

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: coffee group; caffeine coffee	Other: caffeine coffee; drank 3 cups of caffeinated coffee daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda. Coffee was prepared with a conventional coffee machine
EXPERIMENTAL: decaffeinete coffee group	Other: decaffiene coffee; drank 3 cups of decaffeinated coffee daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda. Coffee was prepared with a conventional coffee machine
EXPERIMENTAL: water group	Other: still water; drank 3 cups of still water daily (100 mL at 05:00 AM, 10:00 PM, and 15:00 PM), beginning on the morning after surgery Patients were free to drink any amount of water but no more coffee, black tea, or other form of caffeine, such as soda. Coffee was prepared with a conventional coffee machine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to flatus	measure time to first flatus after finished operation	ึ7 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
time to toleration of a solid diet	The time to tolerance of a solid diet was measured from the end of surgery (defined as when the patients woke up from anesthesia) until the patient tolerated the intake of solid food (any food that required chewing) without vomiting or experiencing significant nausea within 4 hours after the meal and without reversion to enteral fluids only	7 day
time to defecation	measure time to first defecation after finished operation	7 day

Collaborators and Investigators

• Sponsor: Rajavithi Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 3, 2018
• Primary Completion (ACTUAL): September 30, 2019
• Study Completion (ACTUAL): September 30, 2019

Study Registration Dates

• First Submitted: September 4, 2018
• First Submitted That Met QC Criteria: September 5, 2018
• First Posted (ACTUAL): September 6, 2018

Study Record Updates

• Last Update Posted (ACTUAL): October 30, 2019
• Last Update Submitted That Met QC Criteria: October 28, 2019
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: Benign Gynecologic Operation; Coffee Ingestion; Recovery of Bowel Function
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Purinergic Antagonists; Purinergic Agents; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Central Nervous System Stimulants; Caffeine
• Other Study ID Numbers: coffeeaof

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No