>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

Effects of Coffee Ingestion on Recovery of Bowel Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03660267
• Other study ID #: coffeeaof
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: September 30, 2019

Study information

• Verified date: July 2018
• Source: Rajavithi Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: September 30, 2019
• Est. primary completion date: September 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Effects of Coffee Ingestion on Recovery of Bowel Function

Intervention

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
• 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
• 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

Locations

Country	Name	City	State
Thailand	Rajavithi Hospital	Phaya Thai	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Rajavithi Hospital

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	time to flatus	measure time to first flatus after finished operation	?7 day
Secondary	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
Secondary	time to defecation	measure time to first defecation after finished operation	7 day