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

NCT ID: NCT05167890

Last Updated: 2021-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-22

Study Completion Date

2023-01-25

Brief Summary

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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

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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

Conditions

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Colorectal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Coffee

Intervention Type DIETARY_SUPPLEMENT

Coffee 3 times per day

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.

Group Type ACTIVE_COMPARATOR

Orange juice

Intervention Type DIETARY_SUPPLEMENT

Orange juice 3 times per day

Interventions

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Coffee

Coffee 3 times per day

Intervention Type DIETARY_SUPPLEMENT

Orange juice

Orange juice 3 times per day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute, Egypt

OTHER

Sponsor Role lead

Responsible Party

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Yasser Debakey

Lecturer of surgical oncology, NCI, Cairo University

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ahmed M Mahmoud, Professor

Role: STUDY_DIRECTOR

National Cancer Institute, Cairo University, Egypt

Locations

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National Cancer Institute

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Yasser A Debakey, Lecturer

Role: CONTACT

Phone: +201001340579

Email: [email protected]

Ahmed M Mahmoud, Professor

Role: CONTACT

Phone: +201001729571

Email: [email protected]

Facility Contacts

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Ahmed M Mahmoud, Professor

Role: primary

Other Identifiers

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Debakey2

Identifier Type: -

Identifier Source: org_study_id