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

NCT05167890 | Unknown

• 1 other identifier: Debakey2
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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).

Conditions

Colorectal Surgery

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

Coffee Arm

ACTIVE COMPARATOR

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

Orange Arm

ACTIVE COMPARATOR

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

Interventions

Coffee DIETARY_SUPPLEMENT

Coffee 3 times per day

Coffee Arm

Orange juice DIETARY_SUPPLEMENT

Orange juice 3 times per day

Orange Arm

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing elective laparoscopic colon or rectal resection

You may not qualify if:

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

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

National Cancer Institute

Cairo, Egypt

RECRUITING

MeSH Terms

Interventions

Coffee

Intervention Hierarchy (Ancestors)

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

Study Officials

• Ahmed M Mahmoud, Professor

  National Cancer Institute, Cairo University, Egypt

  STUDY DIRECTOR

Central Study Contacts

Yasser A Debakey, Lecturer

CONTACT

+201001340579; y.eldebakey@cu.edu.eg

Ahmed M Mahmoud, Professor

CONTACT

+201001729571; drbarbary@yahoo.com

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: Lecturer of surgical oncology, NCI, Cairo University

Study Record Dates

• First Submitted: November 30, 2021
• First Posted: December 22, 2021
• Study Start: November 22, 2021
• Primary Completion: January 22, 2023
• Study Completion: January 25, 2023
• Last Updated: December 22, 2021

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After publication and for a year
• Access Criteria: The journal of publication

Locations

EG (1)