Coffee Consumption for Intestinal Function Recovery After Laparoscopic Gynecologic Surgery

NCT ID: NCT03963180

Last Updated: 2020-03-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-27
• Study Completion Date: 2019-12-31

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.

Conditions

Postoperative Ileus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

control group

the control group received 3 cups hot water on the 6th, 12th and 18th hours after the operation

Group Type: NO_INTERVENTION

No interventions assigned to this group

study group

drank 3 cups of caffeinated coffee on the 6th, 12th and 18th hours after the operation.

Group Type: EXPERIMENTAL

coffee

Intervention Type: OTHER

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).

Interventions

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Erzincan Military Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kemal GUNGORDUK

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kemal Gungorduk

Muğla, , Turkey (Türkiye)

Mugla Sıtkı Kocman University Education and Research Hospital

Muğla, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

mugla-2

Identifier Type: -

Identifier Source: org_study_id