Influence of Coffee Intake on Postoperative Bowel Function After Comprehensive Staging Surgery for Gynecological Malignancies: A Randomized Controlled Trial.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Kemal GUNGORDUK, Erzincan Military Hospital
ClinicalTrials.gov Identifier:
NCT01990482
First received: November 10, 2013
Last updated: April 21, 2016
Last verified: November 2013
  Purpose

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.


Condition Intervention
Ilues
Dietary Supplement: caffe
Dietary Supplement: Water

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Erzincan Military Hospital:

Primary Outcome Measures:
  • time to first flatus [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]
    hours from end of operation to first flatus pass time


Secondary Outcome Measures:
  • time to tolerance diet [ Time Frame: within the first 30 days after surgery ] [ Designated as safety issue: Yes ]
    time to end of the surgery until the first solid diet intake without vomiting


Enrollment: 118
Study Start Date: November 2013
Study Completion Date: February 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: coffee
coffee
Dietary Supplement: caffe Dietary Supplement: Water
Placebo Comparator: water group
water
Dietary Supplement: caffe Dietary Supplement: Water

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Female patients preparing for complete surgical staging for malignant gynecologic disease such as endometrial cancer, cervix cancer and ovarian cancerwere assessed for eligibility. Exclusion Criteria: Exclusion criteria for the study
  • 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01990482

Locations
Turkey
Tepecik Education Research Hospital
Izmir, Tepecik, Turkey, 35600
Sponsors and Collaborators
Erzincan Military Hospital
  More Information

Responsible Party: Kemal GUNGORDUK, Medical Doctor, Erzincan Military Hospital
ClinicalTrials.gov Identifier: NCT01990482     History of Changes
Other Study ID Numbers: gungorduk15 
Study First Received: November 10, 2013
Last Updated: April 21, 2016
Health Authority: United States: Food and Drug Administration
Turkey: Ethics Committee

ClinicalTrials.gov processed this record on July 21, 2016