NCT06291389

Brief 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. This study aimed to evaluate the effect of intraoperative changes in peak airway pressure (PAP) after muscle plication on postoperative pulmonary function.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
8mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress78%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

February 26, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 4, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

March 10, 2024

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2026

Last Updated

January 6, 2026

Status Verified

November 1, 2025

Enrollment Period

2.8 years

First QC Date

February 26, 2024

Last Update Submit

January 4, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    4 hours

Secondary Outcomes (4)

  • Duration of oxygen therapy

    1 week

  • Post operative Tidal Volume (Vt) (Measured by spirometer)

    24 hours postoperatively

  • Post operative Respiratory Rate (RR)

    24 hours postoperatively

  • Hospital stay.

    1 week

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

age ranged between 20 and 50 years old,- American Society of Anesthesiologists (ASA) physical status classification I and came for abdominoplasty operation

You may qualify if:

  • age ranged between 20 and 50 years old,
  • American Society of Anesthesiologists (ASA) physical status classification I
  • came for abdominoplasty operation

You may not qualify if:

  • anemia or hemoglobin levels below 11g/dl
  • bleeding problems
  • cardiovascular disorders
  • restrictive and obstructive respiratory disease
  • abdominoplasty without plication.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Neveen Kohaf

Tanta, Egypt, 11865, Egypt

RECRUITING

MeSH Terms

Conditions

Intra-Abdominal Hypertension

Condition Hierarchy (Ancestors)

Compartment SyndromesMuscular DiseasesMusculoskeletal DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Neveen Kohaf, ph.d

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Neveen Kohaf, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Clinical Pharmacy

Study Record Dates

First Submitted

February 26, 2024

First Posted

March 4, 2024

Study Start

March 10, 2024

Primary Completion (Estimated)

December 15, 2026

Study Completion (Estimated)

December 15, 2026

Last Updated

January 6, 2026

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will share

Data will be shared upon resealable request from principle investigator

Shared Documents
STUDY PROTOCOL, SAP

Locations