Status:
NOT_YET_RECRUITING
Temporary Application of Abdominal Jackson-Pratt Drain to Reduce Pain After Laparoscopic Surgery in Gynecology
Lead Sponsor:
Università degli Studi dell'Insubria
Conditions:
Postoperative Pain
Eligibility:
FEMALE
Phase:
NA
Brief Summary
Recent evidence has shown that the onset and intensity of post-operative pain are significantly related to the amount of residual pneumoperitoneum at the end of the surgical procedure. In addition, th...
Detailed Description
Laparoscopy in gynecological surgery offers numerous advantages, such as the reduction of operative time, intra-operative blood loss, post-operative pain and the possibility of early hospital discharg...
Eligibility Criteria
Inclusion
- Patients affected by uterine fibroids, undergoing laparoscopic surgery;
- American Society of Anesthesiologists physical status classification I-II.
Exclusion
- inability to express pain;
- any concomitant diseases requiring upper abdominal surgery, such as cholecystectomy or adhesiolysis;
- laparoscopic procedures that were converted to open surgery;
- other causes of known pain;
- oncological cases;
- use of drugs for chronic pelvic pain or hormones in the previous 3 months (wash-out period);
- application of other drainages;
- intra- or post-operative complications.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 15 2027
Estimated Enrollment :
94 Patients enrolled
Trial Details
Trial ID
NCT03440086
Start Date
June 1 2025
End Date
June 15 2027
Last Update
November 2 2022
Active Locations (1)
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1
University of Insubria
Varese, Italy, 21100