Impact of Varying Doses of Prucalopride on Improving Gut Function Recovery After Elective Colorectal Surgery

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorFuture University in Egypt

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

undergoing elective colorectal surgery, including but not limited to colectomy, rectal resection, and sigmoid resection.

Disqualifiers

Emergency surgery

Total colectomy

Creation of a stoma

Pre-existing gastrointestinal disorders

Trial design

Design model

Parallel

Treatments tested in this trial

  • Prucalopride 2mg

    Drug

    Prucalopride 2mg taken preoperatively

  • Prucalopride 4mg

    Drug

    Prucalopride 4mg taken preoperatively

  • Standard Care

    Other intervention

    Standard Supportive care

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Control armPlacebo comparator 1 intervention
Group B: Prucalopride 2mgExperimental treatment 2 interventions
Group C: Prucalopride 4mgExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

time to first stool

Time frame
7 days
2

time to tolerance of food

Time frame
7 days

Secondary outcomes

1

time to first flatus

Time frame
7 days
2

incidence of prolonged postoperative ileus

Time frame
7 days

Other outcomes

Sponsors and contacts

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