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

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Erzincan Military Hospital
Sponsor:
Information provided by (Responsible Party):
Kemal GUNGORDUK, Erzincan Military Hospital
ClinicalTrials.gov Identifier:
NCT01990482
First received: November 10, 2013
Last updated: November 17, 2013
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


Estimated Enrollment: 118
Study Start Date: November 2013
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2014 (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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01990482

Contacts
Contact: Kemal Gungorduk, M.D. 90 0505 492 71 66 maidenkemal@yahoo.com
Contact: Aykut Ozdemir, M.D. 90 0505 795 111 58 isaaykutozdemir@hotmail.com

Locations
Turkey
Tepecik Education Research Hospital Recruiting
Izmir, Tepecik, Turkey, 35600
Contact: mehmet gokcu, MD    90 0532 478 54 57    gokcumehmet@gmail.com   
Principal Investigator: Kemal Gungorduk, M.D.         
Sponsors and Collaborators
Erzincan Military Hospital
  More Information

No publications provided

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: November 17, 2013
Health Authority: United States: Food and Drug Administration
Turkey: Ethics Committee

ClinicalTrials.gov processed this record on July 26, 2014