Colorectal SurgeryNCT05167890
Impact of Coffee vs Orange Juice on Enhancing Recovery After Laparoscopic Colorectal Surgery
A study testing Coffee and Orange juice in people with Colorectal Surgery, run by National Cancer Institute, Egypt at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Colorectal Surgery
- What is being tested?
- Coffee and Orange juice
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Nov 2021to 25 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients undergoing elective laparoscopic colon or rectal resection
Who cannot join
- Creation of a colostomy or ileostomy,
- Any additional small bowel anastomosis,
- Emergency operations,
- known hypersensitivity or allergy to coffee or orange.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
National Cancer Institute
Cairo
Ahmed M Mahmoud, Professor, +201001729571, drbarbary@yahoo.com
About this study
Official title: 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).
Read the 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:
- Coffee Arm: receiving coffee (Turkish sugar free coffee).
- 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
- Colorectal Surgery
- Being tested
- Coffee, Orange juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CoffeeDietary supplement
Coffee 3 times per day
Orange juiceDietary supplement
Orange juice 3 times per day
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Dietary Supplement: Orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From day of surgery to-day of hospital discharge (up to 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2021
- Study start22 Nov 2021
- Primary completion22 Jan 2023 (estimated)
- Study completion25 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal SurgeryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Institute, Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Debakey, National Cancer Institute, Egypt
- Investigators
- Ahmed M Mahmoud, Professor, Study director, National Cancer Institute, Cairo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05167890
- Sponsor's protocol ID
- Debakey2
- Status last verified
- Dec 2021
- First submitted
- 30 Nov 2021
- Last updated
- 22 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In a publication
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Standardized Coffee Versus Orange Juice Intake on Enhancing Bowel Movements After Elective Laparoscopic Colorectal Surgery, RCT
- ClinicalTrials.gov ID
- NCT05167890
- Acronym / sponsor ID
- Debakey2
- Conditions
- Colorectal Surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Cancer Institute, EgyptUniversity, hospital or other
- Study start
- 22 Nov 2021 (actual)
- Primary completion
- 22 Jan 2023 (estimated)
- Study completion
- 25 Jan 2023 (estimated)
- First posted
- 22 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Coffee Arm: receiving coffee (Turkish sugar free coffee).
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coffee Arm | Active comparator | Dietary Supplement: CoffeePatients 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. |
| Orange Arm | Active comparator | Dietary Supplement: Orange juicePatients 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients undergoing elective laparoscopic colon or rectal resection
Key exclusion criteria (4 listed)
- Creation of a colostomy or ileostomy,
- Any additional small bowel anastomosis,
- Emergency operations,
- known hypersensitivity or allergy to coffee or orange.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CoffeeCoffee 3 times per day | Dietary supplement | Coffee Arm |
| Orange juiceOrange juice 3 times per day | Dietary supplement | Orange Arm |
Primary outcome
Primary end point is time to first bowel movement (flatus or stool) starting at the time of surgery completion.
Time frame: From day of surgery to-day of hospital discharge (up to 2 weeks)
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2021.
- Individual participant dataSharing planned: Yes. In a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ahmed M Mahmoud, Professor study director
National Cancer Institute, Cairo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coffee and Orange juice in people with Colorectal Surgery, run by National Cancer Institute, Egypt at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasser A Debakey, Lecturer (+201001340579, y.eldebakey@cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary end point is time to first bowel movement (flatus or stool) starting at the time of surgery completion. (time frame: From day of surgery to-day of hospital discharge (up to 2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2021.