Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2025-12-25 @ 1:26 AM
NCT ID:
NCT07109193
Eligibility Criteria:
Inclusion Criteria:
* Elective procedure: Patients scheduled for elective pure laparoscopic gynecologic surgery (e.g., ovarian cystectomy, endometriosis resection, diagnostic laparoscopy).
* ASA Physical Status: I-II (i.e., healthy or mild systemic disease).
BMI: 18-35 kg/m².
Informed Consent: Able and willing to give written consent and comply with postoperative pain assessments.
Exclusion Criteria:
1 - Malignancy: Known or suspected gynecologic malignancy requiring staging or radical surgery.
2\. Conversion: Intraoperative conversion to laparotomy.
3\. Coagulopathy: Bleeding disorders or therapeutic anticoagulation that cannot be paused perioperatively.
4\. Prior Major Pelvic Surgery: ≥ 2 previous open abdominal operations (to avoid confounding from adhesions).
5\. Intra-Abdominal Infection: Active pelvic inflammatory disease or untreated urinary tract infection.
6\. Chronic Pain/Opioid Use: Regular opioid use or chronic pelvic pain syndromes (endometriosis pain \> 6 months).
7\. Allergy/Contraindication: Allergy to standard analgesics or contraindication to intraperitoneal drain placement (e.g., severe adhesions).
Healthy Volunteers:
True
Sex:
FEMALE
Study:
NCT07109193
Study Brief:
Protocol Section:
NCT07109193