Coffee Consumption for Intestinal Function Recovery After Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 100
- Locations
- 4
- Primary Endpoint
- Time to first passage of flatus
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
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 >24 hours postoperatively,
- •the requirement for nasogastric tube drainage beyond the end of the surgery
- •requirement bowel anastomosis
- •conversion to laparotomy.
Outcomes
Primary Outcomes
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 Outcomes
- Time to the first bowel movement(72 hours)
- Time to tolerance of a solid diet(72 hours)
Investigators
Kemal GUNGORDUK
Principal Investigator
Erzincan Military Hospital