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Coffee Consumption for Intestinal Function Recovery After Laparoscopic Gynecologic Surgery

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ClinicalTrials.gov Identifier: NCT03963180
Recruitment Status : Not yet recruiting
First Posted : May 24, 2019
Last Update Posted : May 24, 2019
Sponsor:
Information provided by (Responsible Party):
Kemal GUNGORDUK, Erzincan Military Hospital

Brief Summary:

Minimally invasive surgery (MIS) has revolutionized women's healthcare. Laparoscopy is an excellent route of MIS. Today, laparoscopic surgery is one of the major procedure in the management of a gynecologic disease. It has revealed benefits of decreased morbidity, earlier discharged, and quicker return to normal daily activities, and shorter hospital when compared to abdominal approach.

Postoperative ileus (POI) defined as an uncomplicated ileus occurring following surgery, resolving spontaneously within 2 to 3 days. Clinically, it is characterized by abdominal distension, a lack of bowel sounds, nausea, vomiting, stomach cramps, and lack of flatus. It leads to morbidity and delays in patient discharge from the hospital, leading to an increased economic burden on the healthcare system. That's why many researchers have focused on the prevent of postoperative ileus; many studies have investigated preventive approaches such as early mobilization of the patient, adequate pain control, epidural anaesthesia, hot pack therapy, motility agents such as metoclopramide, and alvimopan. Although POI incidence has lower after the laparoscopic surgery it remains a major problem during the postoperative period.

Recent studies demonstrated that coffee consumption is associated with improved gastrointestinal function without worsening of postoperative morbidity for both open and laparoscopic surgery. However, until now, no studies investigating the effect of postoperative coffee consumption at laparoscopic gynecologic surgery. Therefore, the investigators performed a randomized controlled trial to assess whether coffee consumption accelerates the recovery of bowel function after laparoscopic gynecologic surgery.


Condition or disease Intervention/treatment Phase
Postoperative Ileus Other: coffee Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Coffee Consumption for Intestinal Function Recovery After Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial
Estimated Study Start Date : May 27, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Arm Intervention/treatment
No Intervention: control group
the control group received 3 cups hot water on the 6th, 12th and 18th hours after the operation
Experimental: study group
drank 3 cups of caffeinated coffee on the 6th, 12th and 18th hours after the operation.
Other: coffee
All patients were asked to drink the entire 150-mL amounts within 20 minutes under the supervision of a nurse or doctor. Patients were free to drink any amount of water but no more coffee, black tea, or other forms of caffeine, such as soda. Coffee and hot water were prepared with a conventional coffee machine (Nescafe Alegria; 100 g caffeine; Nestlé. Gatwick, United Kingdom).




Primary Outcome Measures :
  1. Time to first passage of flatus [ Time Frame: 72 hours ]
    Patients were checked hourly by auscultation for bowel sounds and were asked to note the time of first flatus and defecation and to inform the observing nurses or assistant.The time to the first passage of flatus after surgery during routine postoperative care.


Secondary Outcome Measures :
  1. Time to tolerance of a solid diet [ Time Frame: 72 hours ]
    The time to tolerance of a solid diet was measured from the end of surgery which was defined as when the patients woke up from anesthesia until the patient tolerated the intake of solid food (any food that required chewing) without vomiting or experiencing significant nausea within 4 hours after the meal and without reversion to enteral fluids only

  2. Time to the first bowel movement [ Time Frame: 72 hours ]
    The time to the first bowel movement was defined as the time to the first audible bowel sound during routine postoperative care.



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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Patients underwent total laparoscopic hysterectomy with or without additional surgery *salpingo-oophorectomy,

  • salpingectomy,
  • pelvic and/or para-aortic lymphadenectomy

Exclusion Criteria:

  • patients with hypersensitivity or allergy to caffeine/ coffee,
  • patients with thyroid disease,
  • patients with inflammatory bowel disease,
  • patients with compromised liver function,
  • patients with clinically significant cardiac arrhythmia,
  • patients with chronic constipation (defined as < 2 bowel movements per week),
  • patients with a history of abdominal bowel surgery,
  • patients with previous abdominal irradiation,
  • the requirement for postoperative care in the intensive care unit
  • conversion to laparotomy.

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): NCT03963180


Contacts
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Contact: GUNGORDUK GUNGORDUK +905054921766 maidenkemal@yahoo.com
Contact: KEMAL GUNGORDUK 5054921766 maidenkemal@yahoo.com

Sponsors and Collaborators
Erzincan Military Hospital

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Responsible Party: Kemal GUNGORDUK, Principal Investigator, Erzincan Military Hospital
ClinicalTrials.gov Identifier: NCT03963180     History of Changes
Other Study ID Numbers: mugla-2
First Posted: May 24, 2019    Key Record Dates
Last Update Posted: May 24, 2019
Last Verified: May 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No