Clinical trial NCT05167890: Impact of Coffee vs Orange Juice on Enhancing Recovery After Laparoscopic Colorectal Surgery
Official title: Impact of Standardized Coffee Versus Orange Juice Intake on Enhancing Bowel Movements After Elective Laparoscopic Colorectal Surgery, RCT
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Surgery
Lead sponsor: National Cancer Institute, Egypt
Sponsor class: OTHER
First posted: 2021-12-22
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Colorectal surgery, even performed by laparoscopy is followed by a transient episode of GI hypomotility, which results in a postoperative ileus (POI). The usual duration of this benign postoperative situation varies between 3 and 5 days for colon surgery. A longer duration of POI will result in more postoperative complications such as delayed surgical wound healing, atelectasis, pneumonia, and deep vein thrombosis; in a prolonged hospital stay; and increased healthcare cost. Different studies reported that the duration of POI correlates with total surgery time, blood loss, total opiate dose degree of surgical trauma, and bowel manipulation. Many attempts have been made to reduce the phase of postoperative intestinal hypomotility. The different strategies are well described in enhanced recovery and fast-track concepts and focus on minimal surgical trauma, rapid postoperative mobilization, early feeding, preemotive laxative treatment, restrictive fluid management, and minimal postoperative opioid prescription. Furthermore, several pharmacologic agents have been evaluated; however, not all offered a convincing benefit, nor were they free of adverse effects. Coffee is a worldwide highly consumed beverage, offering pleasure to many people of different cultures, and which many associate with an increase of bowel function.

The aim of this study is to compare the time to first bowel movement after laparoscopic colorectal surgery between patients drinking coffee or orange juice postoperatively, in a randomized controlled trial (RCT).

Detailed description: The study is designed as a multi-center, open-label RCT. All of the eligible patients undergoing elective laparoscopic colon or rectal resection are considered for participation in the study unless exclusion criteria are present. Written informed consent is obtained after hospital admission.

Patients will be classified into two groups:

1. Coffee Arm: receiving coffee (Turkish sugar free coffee).
2. Orange Arm: receiving orange juice (fresh sugar free). Baseline demographics, peri-operative data (HB, serum Alb and electrolytes), duration of operation, conversion rate to open surgery, estimated blood loss, short-term outcome, and LOS (length of hospital stay) will be analyzed.

Exclusion criteria:

Creation of a colostomy or ileostomy, Any additional small bowel anastomosis, Emergency operations, known hypersensitivity or allergy to coffee or orange.

Patients in coffee arm receive 1 cup of coffee 3 times per day (150 mL at 8:00 AM, 12:00 PM, and5:00 PM), in addition to the regular infusion therapy and/or alimentation starting the first day postoperatively till the end of the 3 postoperative day. In orange arm, the same protocol is applied, replacing coffee with orange juice. All of the patients drink the same quantity of each drink.

Methodology Type of study: open-labeled randomized controlled trial The assignment of patients to either group will be done by a random computer-assissted allocation. The allocation will be done by the use of opaque envelopes with assignments.

Follow up: will be completed within one month (immediate post-operative outcome).

Outcome Measures:

* primary end point was time to first bowel movement (flatus or stool) starting at the time of surgery completion. Included patients are given a diary and are asked (after instruction) to document on a daily basis if they had defecation or flatus and what time; this was verified 3 times per day by the nurse.
* Secondary end points include the number of postoperative bowel movements until discharge, length of hospital stay, and postoperative complications (Dindo-Clavien classification) and are documented by the resident in charge of the patient. All of the patients are discharged with an appointment for a 30-day follow-up

Eligibility criteria: Inclusion Criteria:

* patients undergoing elective laparoscopic colon or rectal resection

Exclusion Criteria:

* Creation of a colostomy or ileostomy,
* Any additional small bowel anastomosis,
* Emergency operations,
* known hypersensitivity or allergy to coffee or orange.

Primary outcomes:
measure: Primary end point is time to first bowel movement (flatus or stool) starting at the time of surgery completion.
timeFrame: From day of surgery to-day of hospital discharge (up to 2 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: National Cancer Institute
Study officials:
affiliation: National Cancer Institute, Cairo University, Egypt
name: Ahmed M Mahmoud, Professor
role: STUDY_DIRECTOR
References: