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Effectiveness of post-operative domperidone use for postoperative bowel ileus prevention after elective gynecologic laparotomy: a double-blinded randomized controlled trial

Effectiveness of post-operative domperidone use for postoperative bowel ileus prevention after elective gynecologic laparotomy: a double-blinded randomized controlled trial

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250403003
Enrollment
168
Registered
2025-04-03
Start date
2025-04-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Ileus Postoperative Ileus

Interventions

Domperidone 10 mg per tab ,Placebo : external appearance same domperidone
Active Comparator Drug,Placebo Comparator Drug
Domperidone,Placebo

Sponsors

Phramongkutklao Hospital Foundation
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to No maximum

Inclusion criteria

Inclusion criteria: Age 20 and above undergoing elective gynecologic laparotomy surgery

Exclusion criteria

Exclusion criteria: 1. Allergic or contraindication to domperidone use 2. Emergency surgery 3. Know history of gastrointestinal disease, including chronic constipation, irritable bowel syndrome (IBS), inflammatory bowel disease, colorectal cancer, cirrhosis, hepatitis, pancreatitis 4. Requirement for postoperative NPO status that precludes oral administration of the study medication 5. Requirement for postoperative admission to the ICU 6. Cannot communicate in Thai

Design outcomes

Primary

MeasureTime frame
Time to first flatus Time to first flatus from post-operative time Patients will be asked to report time to first flatulence to the physician in charge. Information will be documented in the case record form,Abdominal distension score Postoperative of abdominal distension score Patients will be asked to rate the level of abdominal distention score she experience overnight and at 4:00 pm.

Secondary

MeasureTime frame
Time to defecation Time to defecation from post-operative time Patients will be asked to report time to first defication to the physician in charge. Information will be documented in the case record form,Time to resume solid food time to resume solid food from post-operative time Patients will be asked to report time to resume solid food to the physician in charge. Information will be documented in the case record form,Time to start ambulation Time to start ambulation (out of bed) from post-operative time Patients will be asked to report time to start ambulation to the physician in charge. time when they got out of bed, in which all the timing will be documented in the case record form.,Postoperative nausea and vomiting reduction postoperative nausea and vomiting scale Postoperative nausea and vomiting scale will be assessed twice daily by two questions of postoperative nausea and vomiting scale (PONV),Postoperative ileus and management from post-operative time They will be required to further tick fulfilling criteria of bowel ileus to confirm its diagnosis. After diagnosis, treatment method of postoperative ileus is also collected.,Length of stay time from post-operative time to discharge The length of stay will begin from post operation until patient fulfilling the discharge criteria,Antiemetic drug and laxative use Type of antiemetic drug and laxative use from post-operative time Antiemetic drug and laxative use will be reviewed by the research team by looking at medical records and medication orders retrospectively.,Compliance to domperidone protocol Time to compliance to domperidone protocol Medical record of nurse drug administration will be retrospectively reviewed to identify the time each participants take domperidone/placebo pill and the total number of dosage used.

Countries

Thailand

Contacts

Public Contactrojana hongsai

Phramongkutklao Hospital

roj.ho@pmk.ac.th0954306639

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026