Gynecologic Surgical ProceduresNCT07221487
Comparing Intra-Abdominal Pressure During Gynecologic Laparoscopy
A study testing abdominal pressure in people with Gynecologic Surgical Procedures, run by Nassau University Medical Center at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Surgical Procedures
- What is being tested?
- abdominal pressure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Nov 2025to 21 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- Herpes zoster or shingles
- Frozen shoulder
- Complex regional pain syndrome (CRPS)
- Slipped disc
- Sickle cell disease
- Sciatica
- Trigeminal neuralgia
- Fibromyalgia.
Trial locations and contacts
1 site in 1 country.
United States1 site
Nassau University Medical Center
East Meadow, New York, 11554
About this study
Official title: Low Versus Standard Intra-Abdominal Pressure During Gynecologic Laparoscopy: A Randomized Controlled Trial of Postoperative Pain and Recovery Outcomes
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
Read the 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
- Being tested
- abdominal pressure
- Keywords
- pain, abdominal pressure
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abdominal pressureProcedure or surgery
type of intra-abdominal pressure of either standard or low pressure
| Study group | Role | What they receive |
|---|---|---|
| standard-pressure group | Active comparator | 15 mmHg pressure Receives: Procedure: abdominal pressure |
| low-pressure group | Experimental | 8 mmHg Receives: Procedure: abdominal pressure |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Perioperative/Periprocedural: Three hours after surgery completed
Secondary outcomes (10)
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.
Measured: Perioperative/Periprocedural: 24 hours after surgery completed
Numerical rating scale for pain location in the abdomen
One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain)
Measured: Perioperative/Periprocedural: One hour after surgery
Numerical rating scale for pain location in the shoulder
One item to patient participants to rate the shoulder pain from 0 (no pain) to 10 (worst pain)
Measured: Perioperative/Periprocedural: One hour after surgery
Visual analog scale for pain location in the abdomen
One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain)
Measured: Perioperative/Periprocedural: Three hours after surgery completed
Visual analog scale for pain location in the abdomen
One item to patient participants to rate the abdominal pain from 0 (no pain) to 10 (worst pain)
Measured: Perioperative/Periprocedural: 24 hours after surgery completed
Length of hospital stay
Length of hospital stay for the patient participants after surgery completed measured in minutes. Longer stay defined as greater number of minutes
Measured: Perioperative/Periprocedural
Complications
Presence of nausea or vomiting after surgery in patient participants. Yes responses indicate the presence of complications
Measured: Perioperative/Periprocedural
Hospital Readmission
Hospital readmission to patient participants within 30 days after surgery completed. Yes indicates a hospital readmission
Measured: Perioperative/Periprocedural
Use of non-medicine methods to relieve pain
Provided a checklist to patient participants of non-medicine choices such as cold pack, meditation, prayer, massage, distraction like watching television. A yes to any of these choices indicates use of non-medicine methods to relieve pain
Measured: Perioperative/Periprocedural
Overall Quality of Surgical Visual Field
Question to the surgeon with choices rating the overall surgical conditions throughout the procedure from extremely poor with a choice of 1 to optimal with a choice of 5. Higher scores indicate a better overall quality of surgical visual field
Measured: Perioperative/Periprocedural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2025
- Study start23 Nov 2025
- Primary completion21 Jul 2026
- Study completion21 Jul 2026
Why it stopped: The hospital closed down the Obstetrics and Gynecology department. Patients relevant to the study are no longer available to recruit.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gynecologic Surgical ProceduresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nassau University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PETR ITZHAK, Nassau University Medical Center
- Investigators
- Petr Itzhak, DO, Principal investigator, Nassau University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07221487
- Sponsor's protocol ID
- 25-300
- Status last verified
- Jul 2026
- First submitted
- 24 Oct 2025
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentfied data based upon a reasonable request
Publications
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.
PubMed 37026807
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Versus Standard Intra-Abdominal Pressure During Gynecologic Laparoscopy: A Randomized Controlled Trial of Postoperative Pain and Recovery Outcomes
- ClinicalTrials.gov ID
- NCT07221487
- Acronym / sponsor ID
- 25-300
- Conditions
- Gynecologic Surgical Procedures
- Keywords
- pain, abdominal pressure
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The hospital closed down the Obstetrics and Gynecology department. Patients relevant to the study are no longer available to recruit.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Nassau University Medical CenterUniversity, hospital or other
- Study start
- 23 Nov 2025 (actual)
- Primary completion
- 21 Jul 2026 (actual)
- Study completion
- 21 Jul 2026 (actual)
- First posted
- 28 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard-pressure group | Active comparator | Procedure: abdominal pressure15 mmHg pressure |
| low-pressure group | Experimental | Procedure: abdominal pressure8 mmHg |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Undergoing benign gynecologic laparoscopic surgery with eligible procedures, including the following.
- Salpingectomy
- Cystectomy
- Oophorectomy
- Myomectomy
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| abdominal pressuretype of intra-abdominal pressure of either standard or low pressure | Procedure or surgery | low-pressure group, standard-pressure group |
Primary outcome
PAIN OUT questionnaire
Time frame: Perioperative/Periprocedural: Three hours after surgery completed
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.
10 secondary outcomes
PAIN OUT questionnaire
Time frame: Perioperative/Periprocedural: 24 hours after surgery completed
Numerical rating scale for pain location in the abdomen
Time frame: Perioperative/Periprocedural: One hour after surgery
Numerical rating scale for pain location in the shoulder
Time frame: Perioperative/Periprocedural: One hour after surgery
Visual analog scale for pain location in the abdomen
Time frame: Perioperative/Periprocedural: Three hours after surgery completed
Visual analog scale for pain location in the abdomen
Time frame: Perioperative/Periprocedural: 24 hours after surgery completed
Length of hospital stay
Time frame: Perioperative/Periprocedural
Complications
Time frame: Perioperative/Periprocedural
Hospital Readmission
Time frame: Perioperative/Periprocedural
Use of non-medicine methods to relieve pain
Time frame: Perioperative/Periprocedural
Overall Quality of Surgical Visual Field
Time frame: Perioperative/Periprocedural
Results and safety
The study was stopped early (reason given: The hospital closed down the Obstetrics and Gynecology department. Patients relevant to the study are no longer available to recruit.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Background: PubMed 37026807Reijnders-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.
- Individual participant dataSharing planned: Yes. Deidentfied data based upon a reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Petr Itzhak, DO principal investigator
Nassau University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing abdominal pressure in people with Gynecologic Surgical Procedures, run by Nassau University Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The hospital closed down the Obstetrics and Gynecology department. Patients relevant to the study are no longer available to recruit.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PAIN OUT questionnaire (time frame: Perioperative/Periprocedural: Three hours after surgery completed). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07221487, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.