Intra-Abdominal Pressure for Gynecologic Surgery

Overseen By Petr Itzhak, DO

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Nassau University Medical Center

Disqualifiers: Arthritis, Gout, Metastatic cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: Perioperative/Periprocedural

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether the level of pressure inside the abdomen during laparoscopic (small incision) surgery for non-cancerous gynecologic conditions affects postoperative pain. Researchers compare low pressure (8 mmHg) to standard pressure (15 mmHg) to determine its impact on pain levels. This process is known as Intra-Abdominal Pressure Management. Women scheduled for surgeries like a hysterectomy or cyst removal, who do not have certain pain-related conditions such as arthritis or fibromyalgia, may qualify if they speak English or Spanish. Participants will undergo their usual surgery and report their pain levels at one, three, and 24 hours afterward. As an unphased trial, this study allows participants to contribute to understanding how surgical techniques can enhance recovery experiences.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intra-abdominal pressure management is safe for gynecologic surgery?

Research has shown that using low pressure inside the abdomen during gynecologic laparoscopic surgery can be safe for patients. Studies indicate that a low pressure, such as 8 mmHg, can reduce the risk of minor complications after surgery. It may also lead to less pain and a reduced need for painkillers. Some research even suggests that low pressure may help lessen shoulder pain, which is common after this type of surgery. Although the decrease in pain might be small, using low pressure is often considered a good approach for these procedures. Overall, evidence suggests that low pressure is well-tolerated and could help reduce pain after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the trial for managing intra-abdominal pressure in gynecologic surgery because it could change how surgeries are performed. Unlike the standard approach, which typically involves maintaining a pressure of 15 mmHg, this trial explores the effects of reducing the pressure to 8 mmHg. Lower pressure could mean less stress on the body, potentially leading to quicker recovery times and fewer complications. This trial could pave the way for safer surgical practices and improved patient outcomes.

What evidence suggests that this intra-abdominal pressure management is effective for reducing postoperative pain?

This trial will compare two approaches to managing intra-abdominal pressure during gynecologic laparoscopic surgery. Research has shown that lower abdominal pressure can reduce post-procedure pain. In this trial, participants in the low-pressure group will undergo surgeries with pressure around 8 mmHg. Studies have found this often leads to less pain shortly after surgery, along with fewer issues with nausea and vomiting. This low-pressure method has been successfully used in about 90% of cases. Lower pressure typically results in a shorter hospital stay, suggesting quicker recovery. Overall, reducing pressure during surgery appears to improve patient outcomes. Meanwhile, the standard-pressure group will undergo surgery with the typical pressure of 15 mmHg. ^{1 2 3 6 7}

Who Is on the Research Team?

Petr Itzhak, DO

Principal Investigator

Nassau University Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals undergoing benign gynecologic laparoscopic surgery. Participants will be assessed for postoperative pain at different times after their surgery.

Inclusion Criteria

I am scheduled for a laparoscopic surgery for a non-cancerous gynecologic condition.

I speak either English or Spanish.

Exclusion Criteria

I do not have conditions like arthritis, gout, or fibromyalgia that affect how I feel pain.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo gynecologic laparoscopic surgery with either low (8 mmHg) or standard (15 mmHg) intra-abdominal pressure

Perioperative/Periprocedural

1 visit (in-person)

Follow-up

Participants complete pain measures and are monitored for complications and hospital readmission

24 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Intra-Abdominal Pressure Management

Trial Overview The study compares two levels of intra-abdominal pressure during surgery: a low level (8 mmHg) and a standard level (15 mmHg), to see which one results in less postoperative pain.

How Is the Trial Designed?

Group I: low-pressure group Experimental Treatment 1 Intervention

8 mmHg

Group II: standard-pressure group Active Control 1 Intervention

15 mmHg pressure

Who Is Running the Clinical Trial?

Nassau University Medical Center

Lead Sponsor

Trials

2

Recruited

150+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10389627/

Low intra-abdominal pressure in laparoscopic surgery Low pressure laparoscopy reduces early pain scores, postoperative nausea and vomiting (PONV) and length of stay. Low pressure laparoscopy ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07221487

Comparing Intra-Abdominal Pressure During Gynecologic ... The goal of this clinical trial is to learn if the level of intra-abdominal pressure during benign gynecologic laparoscopic surgery impacts ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4769697/

Low vs Standard Pressures in Gynecologic Laparoscopy In fact, laparoscopic surgeries using low pressure were successfully completed in approximately 90% of cases in a previous review.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S2468784717300181

Low pressure gynecological laparoscopy (7 mmHg) with ... Lowering intra-abdominal pressure during laparoscopy may decrease the degree of surgical injury and further enhance patient outcomes. This study aims to assess ...

5. aagl.confex.com aagl.confex.com/aagl/2020/mediafile/Handout/Session1597/KHuang_CFoley_JRS.pdf

clinical impact of decreasing pneumoperitoneum pressures ... Surgery performed at lower-pressure pneumoperitoneum (≤ 10 mmHg) is associated with lower postoperative pain scores, shorter length of stay, and improved ...

6. ls.amegroups.org ls.amegroups.org/article/view/8244/html

Low-pressure pneumoperitoneum—why and how - Rosenberg Recent evidence suggests that low-pressure pneumoperitoneum may offer advantages in terms of reduced postoperative pain, analgesic consumption, and shoulder ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2213307013000981

Principles of safe abdominal entry in laparoscopic ... In gynecologic surgery, laparoscopy is superior to laparotomy in diminishing minor complications, postoperative pain, and length of hospitalization stay.