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

April 21, 2016 updated by: Kemal GUNGORDUK, Erzincan Military Hospital

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.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

118

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Tepecik
      • Izmir, Tepecik, Turkey, 35600
        • Tepecik Education Research Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: coffee
Placebo Comparator: water group
water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
time to first flatus
Time Frame: within the first 30 days after surgery
hours from end of operation to first flatus pass time
within the first 30 days after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
within the first 30 days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

February 1, 2016

Study Registration Dates

First Submitted

November 10, 2013

First Submitted That Met QC Criteria

November 17, 2013

First Posted (Estimate)

November 21, 2013

Study Record Updates

Last Update Posted (Estimate)

April 22, 2016

Last Update Submitted That Met QC Criteria

April 21, 2016

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • gungorduk15

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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