The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study

NCT05966246 | Completed

• 1 other identifier: 3-2021-0480
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

Brief Summary

In order to improve postoperative ileus in patients undergoing gastrointestinal surgery, digestive medications and prokinetics have been routinely used. Among them, mosapride citrate is widely used as a representative drug, as it is a 5-hydroxytryptamine 4 receptor agonist that increases gastrointestinal motility. Prucalopride succinate (dihydrobenzofurancarboxamide) is a type of 5-hydroxytryptamine 4 receptor agonist that has a higher affinity for the 5-HT4 receptor compared to mosapride (a benzamide derivative) which belongs to the same class of drugs. Prucalopride succinate has been demonstrated to increase both gastric and colonic motility through in vivo and in vitro studies. As mentioned earlier, it exhibits high specificity for the 5-HT4 receptor. The 5-HT4 receptor is not expressed in the gastric mucosa but is expressed at low concentrations in the small intestine, whereas it is highly expressed in the colonic mucosa. Therefore, prucalopride is widely used as a therapeutic agent for chronic constipation by increasing colonic motility. Furthermore, Prucalopride succinate stimulates the 5-HT4 receptors present in the nerve terminals of the myenteric plexus, promoting the release of acetylcholine. The released acetylcholine acts on α7nAch receptors located on the surface of enteric smooth muscle cells, inhibiting inflammatory responses and reducing postoperative ilues. A randomized controlled trial (RCT) conducted on 110 patients who underwent gastrointestinal surgery demonstrated that prucalopride succinate showed significant improvement in gastrointestinal motility compared to the control group. Currently, mosapride citrate is widely used as a prokinetic agent in clinical practice. However, preliminary studies have shown no significant efficacy, and when comparing abdominal X-ray images taken on the third day after surgery, there is no significant difference compared to the placebo group. As a result, it can be observed that the recovery of gastrointestinal motility after surgery is not primarily due to small bowel motility but rather delayed gas passing caused by colon motility. Therefore, it can be assumed that using drugs that increase colon motility may be effective in improving gastrointestinal motility after surgery.

Conditions

Gastric Cancer

Outcome Measures

Primary Outcomes (1)

• Quantitative intestinal motility measurement using radio-opaque markers

  Every day from the 1st day to the 5th day after surgery

Secondary Outcomes (1)

• Measurement of the amount of food intake, first flatus time and first defecation time

  Every day from the 1st day to the 5th day after surgery

Study Arms (2)

Prucalopride succinate group

EXPERIMENTAL

Taking prucalopride succinate from the first day to the fifth day after surgery.

Drug: Arm I : Experimental (Prucalopride succinate group)

Control (mosapride citrate) group

PLACEBO COMPARATOR

Taking mosapride citrate from the first day to the fifth day after surgery.

Drug: Arm II : Control (Mosapride citrate group)

Interventions

Arm I : Experimental (Prucalopride succinate group) DRUG

Experimental group taking prucalopride succinate from day 1 to day 5 after surgery

Prucalopride succinate group

Arm II : Control (Mosapride citrate group) DRUG

Control gourp taking mosapride citrate from day 1 day 5 after surgery

Control (mosapride citrate) group

Eligibility Criteria

• Age: 19 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients diagnosed with gastric adenocarcinoma pathologically before surgery
• Patients who underwent complete surgical resection (R0 resection)
• Patients with an ASA score of 3 or less

You may not qualify if:

• Patients over 80 years of age
• Ascites or peritoneal metastasis
• If you have intestinal obstruction before surgery
• If chemotherapy was performed before surgery
• If cancer other than gastric cancer is diagnosed
• If there is a history of previous major intra-abdominal long-term surgery or abdominal radiation therapy
• In case of liver failure or renal failure
• Pregnant women
• If it is judged that uncontrolled diabetes can affect intestinal function
• If you have a stoma

Sponsors & Collaborators

• Gangnam Severance Hospital: lead

Study Sites (1)

GangnamSeverance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Stomach Neoplasms

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: July 21, 2023
• First Posted: July 28, 2023
• Study Start: January 25, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: August 18, 2023

Record last verified: 2023-08

Locations

KR (1)