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

Primary Purpose

Gastric Cancer

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Arm I : Experimental (Prucalopride succinate group)
Arm II : Control (Mosapride citrate group)
Sponsored by
Gangnam Severance Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastric Cancer

Eligibility Criteria

19 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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

Sites / Locations

  • GangnamSeverance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prucalopride succinate group

Control (mosapride citrate) group

Arm Description

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

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

Outcomes

Primary Outcome Measures

Quantitative intestinal motility measurement using radio-opaque markers

Secondary Outcome Measures

Measurement of the amount of food intake, first flatus time and first defecation time
Quantitatively compare and analyze the amount of food eaten in the test group and the control group. Compare the first flatus appearance time and first defecation time in the test group and the control group.

Full Information

First Posted
July 21, 2023
Last Updated
August 16, 2023
Sponsor
Gangnam Severance Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05966246
Brief Title
The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study
Official Title
The Effect of Prucalopride Succinate on Gastrointestinal Motility After Laparoscopic Gastrectomy : Prospective Double Blind Case-control Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
June 30, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gangnam Severance Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastric Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
106 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Prucalopride succinate group
Arm Type
Experimental
Arm Description
Taking prucalopride succinate from the first day to the fifth day after surgery.
Arm Title
Control (mosapride citrate) group
Arm Type
Placebo Comparator
Arm Description
Taking mosapride citrate from the first day to the fifth day after surgery.
Intervention Type
Drug
Intervention Name(s)
Arm I : Experimental (Prucalopride succinate group)
Intervention Description
Experimental group taking prucalopride succinate from day 1 to day 5 after surgery
Intervention Type
Drug
Intervention Name(s)
Arm II : Control (Mosapride citrate group)
Intervention Description
Control gourp taking mosapride citrate from day 1 day 5 after surgery
Primary Outcome Measure Information:
Title
Quantitative intestinal motility measurement using radio-opaque markers
Time Frame
Every day from the 1st day to the 5th day after surgery
Secondary Outcome Measure Information:
Title
Measurement of the amount of food intake, first flatus time and first defecation time
Description
Quantitatively compare and analyze the amount of food eaten in the test group and the control group. Compare the first flatus appearance time and first defecation time in the test group and the control group.
Time Frame
Every day from the 1st day to the 5th day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
GangnamSeverance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

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