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Coffee Consumption for Intestinal Function Recovery After Laparoscopic Gynecologic Surgery

E

Erzincan Military Hospital

Status

Completed

Conditions

Postoperative Ileus

Treatments

Other: coffee

Study type

Interventional

Funder types

Other

Identifiers

NCT03963180
mugla-2

Details and patient eligibility

About

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.

Enrollment

100 patients

Sex

Female

Ages

21 to 80 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

control group
No Intervention group
Description:
the control group received 3 cups hot water on the 6th, 12th and 18th hours after the operation
study group
Experimental group
Description:
drank 3 cups of caffeinated coffee on the 6th, 12th and 18th hours after the operation.
Treatment:
Other: coffee

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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