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

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ClinicalTrials.gov Identifier: NCT01990482
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : April 22, 2016
Sponsor:
Information provided by (Responsible Party):
Kemal GUNGORDUK, Erzincan Military Hospital

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.


Condition or disease Intervention/treatment Phase
Ilues Dietary Supplement: caffe Dietary Supplement: Water Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : November 2013
Actual Primary Completion Date : February 2016
Actual Study Completion Date : February 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: coffee
coffee
Dietary Supplement: caffe
Dietary Supplement: Water
Placebo Comparator: water group
water
Dietary Supplement: caffe
Dietary Supplement: Water



Primary Outcome Measures :
  1. time to first flatus [ Time Frame: within the first 30 days after surgery ]
    hours from end of operation to first flatus pass time


Secondary Outcome Measures :
  1. time to tolerance diet [ Time Frame: within the first 30 days after surgery ]
    time to end of the surgery until the first solid diet intake without vomiting



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990482


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

Responsible Party: Kemal GUNGORDUK, Medical Doctor, Erzincan Military Hospital
ClinicalTrials.gov Identifier: NCT01990482     History of Changes
Other Study ID Numbers: gungorduk15
First Posted: November 21, 2013    Key Record Dates
Last Update Posted: April 22, 2016
Last Verified: November 2013