Abdominal Compartment SyndromeNCT06291389
Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication
An observational study of Abdominal Compartment Syndrome, run by Al-Azhar University at 1 site in Egypt.
Trial summary
An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Abdominal Compartment Syndrome
- How many people
- 120 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Mar 2024to 15 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Study population: age ranged between 20 and 50 years old,- American Society of Anesthesiologists (ASA) physical status classification I and came for abdominoplasty operation
Who may be able to join
- age ranged between 20 and 50 years old,
- American Society of Anesthesiologists (ASA) physical status classification I
- came for abdominoplasty operation
Who cannot join
- anemia or hemoglobin levels below 11g/dl
- bleeding problems
- cardiovascular disorders
- restrictive and obstructive respiratory disease
- abdominoplasty without plication.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Neveen Kohaf
Tanta, Egypt, 11865
Haney Bauiomy
Ahmed Abosakaya
About this study
Official title: Effects of Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication in Abdominoplasty Operations: A Randomized Double-Blind Trial
An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function.
Read the detailed description
Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This surgical procedure involves the removal of surplus skin and fat around the abdomen, known as panneculectomy, and the anterior abdominal wall muscles' laxity being tightened. This study aimed to elucidate the effect of intraoperative changes in PAP after muscle plication on postoperative pulmonary function.
- Conditions
- Abdominal Compartment Syndrome
- Medical subject headings
- Intra-Abdominal Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative peak airway pressure (PAP)
Intraoperative peak airway pressure (PAP) will be observed Pre-plication, Post- plication in supine position and Post- plication in semi-sitting position
Measured: 4 hours
Secondary outcomes (4)
Duration of oxygen therapy
The duration of oxygen therapy will be recorded
Measured: 1 week
Post operative Tidal Volume (Vt) (Measured by spirometer)
The post operative Tidal Volume (Vt) will be measured by spirometer and will be recorded
Measured: 24 hours postoperatively
Post operative Respiratory Rate (RR)
The Post operative Respiratory Rate (RR) will be recorded
Measured: 24 hours postoperatively
Hospital stay.
The Duration of hospital stay will be recorded
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start10 Mar 2024
- Primary completion15 Dec 2026 (estimated)
- Study completion15 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal Compartment SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
- Investigators
- Neveen Kohaf, ph.d, Principal investigator, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06291389
- Sponsor's protocol ID
- RC.2.8.2023
- Status last verified
- Nov 2025
- First submitted
- 26 Feb 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon resealable request from principle investigator
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intraoperative Peak Airway Pressure Changes on Postoperative Pulmonary Function After Muscle Plication in Abdominoplasty Operations: A Randomized Double-Blind Trial
- ClinicalTrials.gov ID
- NCT06291389
- Acronym / sponsor ID
- RC.2.8.2023
- Conditions
- Abdominal Compartment Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 15 Dec 2026 (estimated)
- First posted
- 4 Mar 2024 (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.
An abdominal panniculus excision procedure is known as an abdominoplasty (panniculectomy). Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function.
Detailed description
Musculofascial plication is a crucial aspect of abdominoplasty, especially for patients with significant divarication of the recti muscles. This surgical procedure involves the removal of surplus skin and fat around the abdomen, known as panneculectomy, and the anterior abdominal wall muscles' laxity being tightened. This study aimed to elucidate the effect of intraoperative changes in PAP after muscle plication on postoperative pulmonary function.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- age ranged between 20 and 50 years old,- American Society of Anesthesiologists (ASA) physical status classification I and came for abdominoplasty operation
Key inclusion criteria (3 listed)
- age ranged between 20 and 50 years old,
- American Society of Anesthesiologists (ASA) physical status classification I
- came for abdominoplasty operation
Key exclusion criteria (5 listed)
- anemia or hemoglobin levels below 11g/dl
- bleeding problems
- cardiovascular disorders
- restrictive and obstructive respiratory disease
- abdominoplasty without plication.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraoperative peak airway pressure (PAP)
Time frame: 4 hours
Intraoperative peak airway pressure (PAP) will be observed Pre-plication, Post- plication in supine position and Post- plication in semi-sitting position
4 secondary outcomes
Duration of oxygen therapy
Time frame: 1 week
Post operative Tidal Volume (Vt) (Measured by spirometer)
Time frame: 24 hours postoperatively
Post operative Respiratory Rate (RR)
Time frame: 24 hours postoperatively
Hospital stay.
Time frame: 1 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon resealable request from principle investigator
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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.
Neveen Kohaf, ph.d principal investigator
Al-Azhar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Compartment Syndrome, run by Al-Azhar University at 1 site in Egypt.
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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 6 Jan 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 Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Neveen Kohaf, Ph.D (+201060383012, nevenabdo@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraoperative peak airway pressure (PAP) (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.