Impact of Coffee vs Orange Juice on Enhancing Recovery After Laparoscopic Colorectal Surgery

Impact of Standardized Coffee Versus Orange Juice Intake on Enhancing Bowel Movements After Elective Laparoscopic Colorectal Surgery, RCT

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).

Study Overview

• Status: Recruiting
• Conditions: Colorectal Surgery
• Intervention / Treatment: Dietary supplement: Coffee; Dietary supplement: Orange juice

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

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasser A Debakey, Lecturer; Phone Number: +201001340579; Email: y.eldebakey@cu.edu.eg
• Study Contact Backup: Name: Ahmed M Mahmoud, Professor; Phone Number: +201001729571; Email: drbarbary@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Recruiting
    • National Cancer Institute
    • Contact: Ahmed M Mahmoud, Professor; Phone Number: +201001729571; Email: drbarbary@yahoo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Coffee Arm; 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.	Dietary supplement: Coffee; Coffee 3 times per day
Active Comparator: Orange Arm; Patients in orange arm receive 1 cup of orange juice 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.	Dietary supplement: Orange juice; Orange juice 3 times per day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary end point is 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.	From day of surgery to-day of hospital discharge (up to 2 weeks)

Collaborators and Investigators

• Sponsor: National Cancer Institute, Egypt

Study record dates

Study Major Dates

• Study Start (Actual): November 22, 2021
• Primary Completion (Anticipated): January 22, 2023
• Study Completion (Anticipated): January 25, 2023

Study Registration Dates

• First Submitted: November 30, 2021
• First Submitted That Met QC Criteria: December 16, 2021
• First Posted (Actual): December 22, 2021

Study Record Updates

• Last Update Posted (Actual): December 22, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: Debakey2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In a publication
• IPD Sharing Time Frame: After publication and for a year
• IPD Sharing Access Criteria: The journal of publication
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No