Rectal indomethacin after prostate surgery to see if it lowers CRBD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Adults undergoing laparoscopic radical prostatectomy are randomized to receive a rectal indomethacin suppository immediately after surgery or no treatment, with the aim of reducing postoperative catheter-related bladder discomfort. The trial focuses on the incidence and severity of CRBD and related pain, comparing the intervention to standard care. Indomethacin’s potential preventive effect on CRBD after prostate surgery is being explored due to limited effectiveness and tolerability of other options. The study is conducted at The First Affiliated Hospital, Zhejiang University School of Medicine, led by Zhejiang University.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Diansan SU, Cheif of Anesthesiology Department, PhD
• Email: 184872238@qq.com
• Phone: +8618616514088

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.