Comparing Intra-Abdominal Pressure During Gynecologic Laparoscopy
United States190 participantsStarted 2025-11
Plain-language summary
The goal of this clinical trial is to learn if the level of intra-abdominal pressure during benign gynecologic laparoscopic surgery impacts postoperative pain.
The main question it aims to answer is:
• Does use of low (8 mmHg) versus standard (15 mmHg) intra-abdominal pressure impact postoperative pain?
Researchers will compare the use of low (8 mmHg) versus standard (15 mmHg) intra-abdominal pressure.
Participants will:
* Undergo their regular scheduled gynecologic laparoscopic surgery
* Complete pain measures one hour, 3 hours, and 24 hours after surgery
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Undergoing benign gynecologic laparoscopic surgery with eligible procedures, including the following.
* Salpingectomy
* Cystectomy
* Oophorectomy
* Myomectomy
* Hysterectomy.
* Only those who speak English or Spanish will be recruited, as our validated questionnaires are only available in those languages.
Exclusion Criteria:
* Participants with the following diseases will be excluded due to their diseases having pain that may strongly interfere with their perception of pain in the area of surgery.
* Arthritis
* Gout
* Metastatic cancer
* Pelvic floor disease
* Headache disorders
* Herpes zoster or shingles
* Frozen shoulder
* Complex regional pain syndrome (CRPS)
* Slipped disc
* Sickle cell disease
* Sciatica
* Trigeminal neuralgia
* Fibromyalgia.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
PAIN OUT questionnaire
Timeframe: Perioperative/Periprocedural: Three hours after surgery completed