NCT01990482

Brief Summary

A delay in the return of normal bowel function with the passage of flatus and feces is one of the most important factors affecting early recovery and discharge in patients undergoing open complete staging surgery for gynecological malignancies. A prolonged hospital stay increases the risk of hospital-acquired infections, deep vein thrombosis, pulmonary compromise and total hospital costs. The aim of this study was to assess the effectiveness of coffee intake on postoperative bowel function in patients undergoing abdominal complete staging surgery for gynecological malignancies.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
118

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2013

Typical duration for not_applicable

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

November 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

November 10, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 21, 2013

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
Last Updated

April 22, 2016

Status Verified

November 1, 2013

Enrollment Period

2.3 years

First QC Date

November 10, 2013

Last Update Submit

April 21, 2016

Conditions

Ilues

Outcome Measures

Primary Outcomes (1)

  • time to first flatus

    hours from end of operation to first flatus pass time

    within the first 30 days after surgery

Secondary Outcomes (1)

  • time to tolerance diet

    within the first 30 days after surgery

Study Arms (2)

coffee

EXPERIMENTAL

coffee

Dietary Supplement: caffeDietary Supplement: Water

water group

PLACEBO COMPARATOR

water

Dietary Supplement: caffeDietary Supplement: Water

Interventions

caffeDIETARY_SUPPLEMENT
coffeewater group
WaterDIETARY_SUPPLEMENT
coffeewater group

Eligibility Criteria

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

You may not qualify if:

  • included thyroid diseases,
  • inflammatory bowel disease,
  • complaints of chronic constipation (defined as two or fewer bowel movements per week),
  • a history of prior abdominal bowel surgery, abdominal radiation, neoadjuvant chemotherapy,
  • need for intensive care more that 24 hpostoperatively,
  • nasogastric tube drainage beyond the first postoperative morning,
  • bowel anastomosis and upper abdominalmultivisceral surgical approaches in relation to the debulking surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tepecik Education Research Hospital

Izmir, Tepecik, 35600, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Water

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

November 10, 2013

First Posted

November 21, 2013

Study Start

November 1, 2013

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

April 22, 2016

Record last verified: 2013-11

Locations

TU(1)