Post-Op ComplicationPhase 3NCT06816407
Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery
A Phase 3 study testing Prucalopride 2mg and Prucalopride 4mg in people with Post-Op Complication, run by Future University in Egypt at 1 site in Egypt.
Trial summary
Postoperative ileus (POI) is a common complication after abdominal surgery, causing symptoms like nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Management remains challenging, with limited pharmacological options available. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Post-Op Complication
- What is being tested?
- Prucalopride 2mg and Prucalopride 4mg
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Mar 2025to May 2025
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing elective colorectal surgery, including but not limited to colectomy, rectal resection, and sigmoid resection.
Who cannot join
- Emergency surgery
- Total colectomy
- Creation of a stoma
- Pre-existing gastrointestinal disorders
- Severe renal or hepatic impairment
- Known hypersensitivity to prucalopride.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Matareya Hospital
Cairo
Eskandar, +201227933624, amireskanderhanna@gmail.com
About this study
Official title: The Effect of Different Doses of Prucalopride on Improving Gut Function Recovery Following Elective Colorectal Surgery: a Randomized, Double-blind Study
Postoperative ileus (POI) is a common complication after abdominal surgery, causing symptoms like nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Management remains challenging, with limited pharmacological options available. Prucalopride, a selective serotonin 5-HT4 receptor agonist, has shown promise in accelerating gastrointestinal recovery after surgery. However, the optimal timing and dosing for preventing POI remains unclear. Higher doses may provide more potent prokinetic effects in the postoperative setting. his study investigates if higher doses of prucalopride (4 mg) improve bowel function return and hospital stay in elective colorectal surgery patients compared to standard doses and placebo.
Read the detailed description
Postoperative ileus (POI) is a common complication after abdominal surgery, particularly colorectal procedures, which can delay recovery and prolong hospital stay. POI is characterized by a transient cessation of coordinated bowel motility, leading to symptoms such as nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Effective management of POI remains challenging, with limited pharmacological options available. Prucalopride, a highly selective serotonin 5-HT4 receptor agonist, has shown promise in accelerating gastrointestinal recovery after surgery. However, the optimal timing and dosing of prucalopride for preventing POI remains unclear. Studies have shown dose-dependent improvements in outcomes with doses up to 4 mg daily. Higher doses may provide more potent prokinetic effects in the postoperative setting, but no studies have examined doses above 2 mg for prevention of POI in colorectal surgery. The purpose of this study is to determine if higher doses of prucalopride (4 mg) result in faster return of bowel function and shorter hospital stay compared to the standard dose (2 mg) and placebo in patients undergoing elective colorectal surgery.
- Conditions
- Post-Op Complication
- Being tested
- Prucalopride 2mg, Prucalopride 4mg, Standard Care
- Keywords
- pro kinetic, gut function recovery
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prucalopride 2mgDrug
Prucalopride 2mg taken preoperatively
Prucalopride 4mgDrug
Prucalopride 4mg taken preoperatively
Standard CareOther
Standard Supportive care
| Study group | Role | What they receive |
|---|---|---|
| Control arm | Placebo comparator | Standard care Receives: Other: Standard Care |
| Prucalopride 2mg | Experimental | Prucalopride 2mg Receives: Drug: Prucalopride 2mg; Other: Standard Care |
| Prucalopride 4mg | Experimental | Prucalopride 4mg Receives: Drug: Prucalopride 4mg; Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to first stool
Measured: 7 days
time to tolerance of food
Measured: 7 days
Secondary outcomes (2)
time to first flatus
Measured: 7 days
incidence of prolonged postoperative ileus
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2025
- Study start2 Mar 2025
- Primary completionMay 2025 (estimated)
- Study completionMay 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Op ComplicationStudies 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 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Future University in Egypt
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nouran Omar El Said, Future University in Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06816407
- Sponsor's protocol ID
- HM000186
- Status last verified
- Mar 2025
- First submitted
- 4 Feb 2025
- Last updated
- 19 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Doses of Prucalopride on Improving Gut Function Recovery Following Elective Colorectal Surgery: a Randomized, Double-blind Study
- ClinicalTrials.gov ID
- NCT06816407
- Acronym / sponsor ID
- HM000186
- Conditions
- Post-Op Complication
- Keywords
- pro kinetic, gut function recovery
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Future University in EgyptUniversity, hospital or other
- Study start
- 2 Mar 2025 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- May 2025 (estimated)
- First posted
- 10 Feb 2025 (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.
Postoperative ileus (POI) is a common complication after abdominal surgery, causing symptoms like nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Management remains challenging, with limited pharmacological options available. Prucalopride, a selective serotonin 5-HT4 receptor agonist, has shown promise in accelerating gastrointestinal recovery after surgery. However, the optimal timing and dosing for preventing POI remains unclear. Higher doses may provide more potent prokinetic effects in the postoperative setting. his study investigates if higher doses of prucalopride (4 mg) improve bowel function return and hospital stay in elective colorectal surgery patients compared to standard doses and placebo.
Detailed description
Postoperative ileus (POI) is a common complication after abdominal surgery, particularly colorectal procedures, which can delay recovery and prolong hospital stay. POI is characterized by a transient cessation of coordinated bowel motility, leading to symptoms such as nausea, vomiting, abdominal distension, and delayed passage of flatus and stool. Effective management of POI remains challenging, with limited pharmacological options available. Prucalopride, a highly selective serotonin 5-HT4 receptor agonist, has shown promise in accelerating gastrointestinal recovery after surgery. However, the optimal timing and dosing of prucalopride for preventing POI remains unclear. Studies have shown dose-dependent improvements in outcomes with doses up to 4 mg daily. Higher doses may provide more potent prokinetic effects in the postoperative setting, but no studies have examined doses above 2 mg for prevention of POI in colorectal surgery. The purpose of this study is to determine if higher doses of prucalopride (4 mg) result in faster return of bowel function and shorter hospital stay compared to the standard dose (2 mg) and placebo in patients undergoing elective colorectal surgery.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control arm | Placebo comparator | Other: Standard CareStandard care |
| Prucalopride 2mg | Experimental | Drug: Prucalopride 2mg, Other: Standard CarePrucalopride 2mg |
| Prucalopride 4mg | Experimental | Drug: Prucalopride 4mg, Other: Standard CarePrucalopride 4mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing elective colorectal surgery, including but not limited to colectomy, rectal resection, and sigmoid resection.
Key exclusion criteria (6 listed)
- Emergency surgery
- Total colectomy
- Creation of a stoma
- Pre-existing gastrointestinal disorders
- Severe renal or hepatic impairment
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 |
|---|---|---|
| Prucalopride 2mgPrucalopride 2mg taken preoperatively | Drug | Prucalopride 2mg |
| Prucalopride 4mgPrucalopride 4mg taken preoperatively | Drug | Prucalopride 4mg |
| Standard CareStandard Supportive care | Other | Control arm, Prucalopride 2mg, Prucalopride 4mg |
Primary outcome
time to first stool
Time frame: 7 days
time to tolerance of food
Time frame: 7 days
2 secondary outcomes
time to first flatus
Time frame: 7 days
incidence of prolonged postoperative ileus
Time frame: 7 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2025.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prucalopride 2mg and Prucalopride 4mg in people with Post-Op Complication, run by Future University in 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 6 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: looking for participants now, as of the sponsor's last update on 19 Mar 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amir Samy Hanna (01227933624, amireskanderhanna@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
time to first stool (time frame: 7 days). The study lists 2 primary outcomes in all. 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 19 Mar 2025.