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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

Tracking Information
First Submitted Date  ICMJE November 10, 2013
First Posted Date  ICMJE November 21, 2013
Last Update Posted Date April 22, 2016
Study Start Date  ICMJE November 2013
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2013)
time to first flatus [ Time Frame: within the first 30 days after surgery ]
hours from end of operation to first flatus pass time
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01990482 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2013)
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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Influence of Coffee Intake on Postoperative Bowel Function After Comprehensive Staging Surgery for Gynecological Malignancies: A Randomized Controlled Trial.
Official Title  ICMJE Not Provided
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Ilues
Intervention  ICMJE
  • Dietary Supplement: caffe
  • Dietary Supplement: Water
Study Arms  ICMJE
  • Experimental: coffee
    coffee
    Interventions:
    • Dietary Supplement: caffe
    • Dietary Supplement: Water
  • Placebo Comparator: water group
    water
    Interventions:
    • Dietary Supplement: caffe
    • Dietary Supplement: Water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 17, 2013)
118
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2016
Actual Primary Completion Date February 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01990482
Other Study ID Numbers  ICMJE gungorduk15
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kemal GUNGORDUK, Erzincan Military Hospital
Study Sponsor  ICMJE Erzincan Military Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Erzincan Military Hospital
Verification Date November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP