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
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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).
- 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.
- 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
- 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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Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03963180
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