Clinical trial NCT03963180: Coffee Consumption for Intestinal Function Recovery After Laparoscopic Gynecologic Surgery
Official title: Coffee Consumption for Intestinal Function Recovery After Laparoscopic Gynecologic Surgery: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Ileus
Lead sponsor: Erzincan Military Hospital
Sponsor class: OTHER
First posted: 2019-05-24
Enrollment: 100
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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 \>24 hours postoperatively,
* the requirement for nasogastric tube drainage beyond the end of the surgery
* requirement bowel anastomosis
* conversion to laparotomy.

Primary outcomes:
measure: Time to first passage of flatus
timeFrame: 72 hours
Secondary outcomes:
measure: Time to tolerance of a solid diet
timeFrame: 72 hours
measure: Time to the first bowel movement
timeFrame: 72 hours
Other outcomes:
Locations:
city: Mugla
country: Turkey
facility: Mugla Sıtkı Kocman University Education and Research Hospital
city: Muğla
country: Turkey
facility: Kemal Gungorduk
Study officials:
References: