NCT07607990 Effects of Rectal Indomethacin Suppository on Postoperative CRBD in Patients Undergoing LRP
| NCT ID | NCT07607990 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhejiang University |
| Condition | Prostate Cancer (Post Prostatectomy) |
| Study Type | INTERVENTIONAL |
| Enrollment | 130 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 130 participants in total. It began in 2026-01-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The postoperative incidence of catheter-related bladder discomfort (CRBD) ranges from 47% to 95%. It increases postoperative pain and agitation, thus requiring early intervention. Although a variety of drugs are used for the prevention or treatment of CRBD, the adverse reactions of most of these drugs have limited their clinical application. In long-term clinical practice, we found that indomethacin suppository has a good therapeutic effect on the discomfort of pelvic-related organs caused by nociceptive stimulation. However, its preventive effect on CRBD has not been reported yet. We hypothesized that indomethacin suppository has a preventive effect on postoperative CRBD. To verify this hypothesis, patients undergoing laparoscopic radical prostatectomy were enrolled in the study. Patients in the intervention group received 50 mg of indomethacin suppository via the rectal route immediately after surgery, while those in the control group received no treatment. The severity of CRBD, pain scores, consumption of analgesics, other perioperative adverse reactions, and patient satisfaction were observed and recorded at 0, 1, 2, and 6 hours after surgery.
Eligibility Criteria
Inclusion Criteria: 1. Aged 18 to 80 years old (inclusive); 2. American Society of Anesthesiologists (ASA) physical status classification Class I-III; 3. Undergoing elective laparoscopic radical prostatectomy under general anesthesia; 4. Having a clear understanding of the study, voluntarily participating, and providing informed consent signed by themselves or their family members. Exclusion Criteria: 1. Pre-existing bladder diseases, such as overactive bladder (frequency of micturition \> 3 times per night or \> 8 times within 24 hours), neurogenic bladder, and bladder outlet obstruction; 2. Postoperative status of pelvic organs or spine that affects bladder function; 3. Postoperative status of total proctocolectomy; 4. Severe cardiac insufficiency (activity tolerance \< 4 METs) or clearly diagnosed coronary heart disease; 5. Clearly diagnosed chronic obstructive pulmonary disease (COPD) or a history of asthma; 6. Hepatic insufficiency with Child-Pugh Class C; 7. Chronic kidney disease requiring dialysis; 8. Active peptic ulcer/hemorrhagic disease; 9. Body mass index (BMI) ≤ 18 kg/m² or ≥ 28 kg/m²; 10. Chronic analgesic abuse; 11. Use of other nonsteroidal anti-inflammatory drugs (NSAIDs) within one week; 12. Hypersensitivity to nonsteroidal anti-inflammatory drugs (NSAIDs); 13. Mental or neurological disorders that prevent the completion of rating scales; or cognitive impairment resulting in the loss of capacity for civil conduct.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07607990 clinical trial?
This trial is open to male participants only, aged 18 Years or older, up to 80 Years, studying Prostate Cancer (Post Prostatectomy). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07607990 currently recruiting?
Yes, NCT07607990 is actively recruiting participants. Contact the research team at 184872238@qq.com for enrollment information.
Where is the NCT07607990 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07607990 clinical trial?
NCT07607990 is sponsored by Zhejiang University. The trial plans to enroll 130 participants.
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