Coffee Consumption for Intestinal Function Recovery After Laparoscopic Gynecologic Surgery

NCT03963180 | Completed

• 1 other identifier: mugla-2
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Time to first passage of flatus

  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.

  72 hours

Secondary Outcomes (2)

• Time to tolerance of a solid diet

  72 hours

• Time to the first bowel movement

  72 hours

Study Arms (2)

control group

NO INTERVENTION

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

study group

EXPERIMENTAL

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

Other: coffee

Interventions

coffee 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).

study group

Eligibility Criteria

• Age: 21 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients underwent total laparoscopic hysterectomy with or without additional surgery \*salpingo-oophorectomy,
• salpingectomy,
• pelvic and/or para-aortic lymphadenectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Erzincan Military Hospital: lead

Study Sites (2)

Kemal Gungorduk

Muğla, 35460, Turkey (Türkiye)

Location

Mugla Sıtkı Kocman University Education and Research Hospital

Muğla, 48000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Coffee

Intervention Hierarchy (Ancestors)

Plant Preparations; Biological Products; Complex Mixtures; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: May 24, 2019
• Study Start: May 27, 2019
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

TU (2)