Comparing Intra-Abdominal Pressure During Gynecologic Laparoscopy

NCT07221487 | Not Yet Recruiting

• 1 other identifier: 25-300
• Study Type: interventional
• Target: 190
• Locations: 1 country
• Sites: 1

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

Conditions

Gynecologic Surgical Procedures

Keywords

pain; abdominal pressure

Outcome Measures

Primary Outcomes (1)

• PAIN OUT questionnaire

  Self-report questionnaire to patient participants focusing on shoulder pain with a total composite score from 12 items. Minimum score is 0 and maximum score is 120. Higher scores indicate greater pain levels.

  Perioperative/Periprocedural: Three hours after surgery completed

Secondary Outcomes (10)

• PAIN OUT questionnaire

  Perioperative/Periprocedural: 24 hours after surgery completed

• Numerical rating scale for pain location in the abdomen

  Perioperative/Periprocedural: One hour after surgery

• Numerical rating scale for pain location in the shoulder

  Perioperative/Periprocedural: One hour after surgery

• Visual analog scale for pain location in the abdomen

  Perioperative/Periprocedural: Three hours after surgery completed

• Visual analog scale for pain location in the abdomen

  Perioperative/Periprocedural: 24 hours after surgery completed

Study Arms (2)

standard-pressure group

ACTIVE COMPARATOR

15 mmHg pressure

Procedure: abdominal pressure

low-pressure group

EXPERIMENTAL

8 mmHg

Procedure: abdominal pressure

Interventions

abdominal pressure PROCEDURE

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

low-pressure group; standard-pressure group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nassau University Medical Center: lead

Study Sites (1)

Nassau University Medical Center

East Meadow, New York, 11554, United States

Location

Related Publications (1)

• 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.

  PMID: 37026807 BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Lower Body Negative Pressure

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Decompression; Therapeutics

Study Officials

• Petr Itzhak, DO

  Nassau University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Petr Itzhak, DO

CONTACT

516-296-7394; pitzhak@numc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician

Study Record Dates

• First Submitted: October 24, 2025
• First Posted: October 28, 2025
• Study Start: November 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After study using data is published
• Access Criteria: Academic researchers

Locations

US (1)