NCT03660267

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

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

September 3, 2018

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 4, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 6, 2018

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2019

Completed
Last Updated

October 30, 2019

Status Verified

July 1, 2018

Enrollment Period

1.1 years

First QC Date

September 4, 2018

Last Update Submit

October 28, 2019

Conditions

Keywords

Benign Gynecologic OperationCoffee IngestionRecovery of Bowel Function

Outcome Measures

Primary Outcomes (1)

  • time to flatus

    measure time to first flatus after finished operation

    ึ7 day

Secondary Outcomes (2)

  • time to toleration of a solid diet

    7 day

  • time to defecation

    7 day

Study Arms (3)

coffee group

EXPERIMENTAL

caffeine coffee

Other: caffeine coffee

decaffeinete coffee group

EXPERIMENTAL

decaffeinete coffee group

Other: decaffiene coffee

water group

EXPERIMENTAL
Other: still water

Interventions

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

coffee group

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

decaffeinete coffee group

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

water group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rajavithi Hospital

Phaya Thai, Bangkok, 10400, Thailand

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 4, 2018

First Posted

September 6, 2018

Study Start

September 3, 2018

Primary Completion

September 30, 2019

Study Completion

September 30, 2019

Last Updated

October 30, 2019

Record last verified: 2018-07

Locations