>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

Not Applicable

Completed

• Conditions: Effects of Coffee Ingestion on Recovery of Bowel Function
• Interventions: Other: caffeine coffee; Other: decaffiene coffee; Other: still water

• Registration Number: NCT03660267
• Lead Sponsor: Rajavithi Hospital

Brief 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

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 Timeline

• Status Verified: 2018-07
• Study Start: 2018-09-03
• Study First Submitted: 2018-09-04
• Study First Submitted QC: 2018-09-05
• Study First Posted: 2018-09-06
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Last Update Submitted: 2019-10-28
• Last Update Posted: 2019-10-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 90

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
coffee group	caffeine coffee	caffeine coffee
decaffeinete coffee group	decaffiene coffee	decaffeinete coffee group
water group	still water	-

Primary Outcome Measures

Name	Time	Method
time to flatus	ึ7 day	measure time to first flatus after finished operation

Secondary Outcome Measures

Name	Time	Method
time to toleration of a solid diet	7 day	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
time to defecation	7 day	measure time to first defecation after finished operation

Trial Locations

Locations (1)

Rajavithi Hospital; 🇹🇭 Phaya Thai, Bangkok, Thailand