Comparing Intra-Abdominal Pressure During Gynecologic Laparoscopy

NCT ID: NCT07221487

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-05-31

Brief 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

Detailed Description

Participants will be randomized into one of two experimental groups using a computer-generated allocation list: a low-pressure group (8 mmHg) or a standard-pressure group (15 mmHg). As part of standard care, many surgeons more often use 15 mmHg which is why this is named as our standard-pressure group. Some surgeons use low-pressure varying from 8 mmHg through 12 mmHg which is why our 8 mmHg is named the low-pressure group. The 8 mmHg is the most common acceptable low-pressure approach reported in the surgical literature. All surgeries will begin with standard insufflation at 15 mmHg to achieve safe abdominal access. Once the operative field is established, if necessary, the pressure will be adjusted according to the assigned group. For those surgeons who use 8 mmHg, standard care is to start at 15 mmHg and then to adjust to the lower pressure of 8 mmHg. Our proposed approach is consistent with standard clinical protocol. General anesthesia will be administered per institutional protocol, and local anesthetic will be applied to all trocar sites.

Conditions

Gynecologic Surgical Procedures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

standard-pressure group

15 mmHg pressure

Group Type: ACTIVE_COMPARATOR

abdominal pressure

Intervention Type: PROCEDURE

type of intra-abdominal pressure of either standard or low pressure

low-pressure group

8 mmHg

Group Type: EXPERIMENTAL

abdominal pressure

Intervention Type: PROCEDURE

type of intra-abdominal pressure of either standard or low pressure

Interventions

abdominal pressure

type of intra-abdominal pressure of either standard or low pressure

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Nassau University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

PETR ITZHAK

Attending Physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Petr Itzhak, DO

Role: PRINCIPAL_INVESTIGATOR

Nassau University Medical Center

Locations

Nassau University Medical Center

East Meadow, New York, United States

Countries

United States

Central Contacts

Petr Itzhak, DO

Role: CONTACT

pitzhak@numc.edu

516-296-7394

Facility Contacts

Petr Itzhak

Role: primary

pitzhak@numc.edu

516-296-7394

References

Reijnders-Boerboom GTJA, Albers KI, Jacobs LMC, Helden EV, Rosman C, Diaz-Cambronero O, Mazzinari G, Scheffer GJ, Keijzer C, Warle MC. Low intra-abdominal pressure in laparoscopic surgery: a systematic review and meta-analysis. Int J Surg. 2023 May 1;109(5):1400-1411. doi: 10.1097/JS9.0000000000000289.

Reference Type: BACKGROUND

PMID: 37026807 (View on PubMed)

Other Identifiers

25-300

Identifier Type: -

Identifier Source: org_study_id