Post-Op ComplicationNCT07373886
Suprapubic Transverse Incision With Rectus Release for Upper Peritoneal Access): A Novel Dual-Plane Technique for Abdominal Wall Incision in Complex Gynecological Surgery
A study testing STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique in people with Post-Op Complication, run by Cairo University.
Trial summary
This study aims to evaluate the clinical effectiveness, anatomical benefits, and postoperative outcomes of the STIRRUP incision (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal Access) by comparing outcomes with historically established benchmarks and published data from traditional abdominal… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Post-Op Complication
- What is being tested?
- STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- 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 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged 18-65 years
- Indication for open gynecologic surgery for benign or borderline pelvic or abdominopelvic masses
- Body Mass Index (BMI) ≥ 18 kg/m²
- Willing and able to provide informed consent and attend follow-up
- Mass size between 15-30 cm, which is considered optimal for the STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique due to the balance between exposure and minimal morbidity
Who cannot join
- Malignant tumors requiring upper abdominal visceral resection (liver, spleen, diaphragm)
- Emergency surgery
- Previous complex abdominal wall reconstruction with mesh
- Contraindication to general anesthesia
- Masses extending to the xiphisternum or measuring >30 cm
- Cases requiring supracolic omentectomy
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- Planned lymphadenectomy (especially if comprehensive para-aortic lymph node dissection is required )
- Supramesocolic tumor extension or malignant ovarian tumors requiring hepatic resections, splenectomy, and diaphragmatic resection
- Severe comorbidities precluding elective surgery
- Pregnancy
- Previous extensive upper abdominal surgery
About this study
This study aims to evaluate the clinical effectiveness, anatomical benefits, and postoperative outcomes of the STIRRUP incision (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal Access) by comparing outcomes with historically established benchmarks and published data from traditional abdominal wall incisions used in complex gynecologic surgery.
- Conditions
- Post-Op Complication
- Being tested
- STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) techniqueProcedure or surgery
Skin incision: A low curvilinear transverse incision will be made 2-3 cm above the pubic symphysis, corresponding to the Pfannenstiel site.
Subcutaneous dissection: The subcutaneous tissue will be elevated between Scarpa's fascia and the anterior rectus sheath for approximately 10-12 cm cephalad.
Anterior rectus sheath incision: A transverse incision will be made in the anterior rectus sheath approximately 10-12 cm above the pubis, parallel to the skin incision. The linea alba will not be divided, thereby preserving midline fascial integrity.
Rectus muscle separation: Beneath the fascial window, the rectus muscles will be separated bluntly at the midline, as in the Pfannenstiel approach, to expose the posterior sheath and peritoneum. No transection of muscle fibers will be performed.
Peritoneal entry: The peritoneum will be opened sharply under direct vision.
| Study group | Role | What they receive |
|---|---|---|
| STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique | Experimental | Skin incision: A low curvilinear transverse incision will be made 2-3 cm above the pubic symphysis, corresponding to the Pfannenstiel site.
Subcutaneous dissection: The subcutaneous tissue will be elevated between Scarpa's fascia and the anterior rectus sheath for approximately 10-12 cm cephalad.
Anterior rectus sheath incision: A transverse incision will be made in the anterior rectus sheath approximately 10-12 cm above the pubis, parallel to the skin incision. The linea alba will not be divided, thereby preserving midline fascial integrity.
Rectus muscle separation: Beneath the fascial window, the rectus muscles will be separated bluntly at the midline, as in the Pfannenstiel approach, to expose the posterior sheath and peritoneum. No transection of muscle fibers will be performed.
Peritoneal entry: The peritoneum will be opened sharply under direct vision. Receives: Procedure: STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative seroma formation
clinically detectable subcutaneous fluid collection at the incision site, confirmed clinically and/or by ultrasound when indicated.
Measured: within the postoperative or follow-up period (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Feb 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Op ComplicationStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdalla Mousa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07373886
- Sponsor's protocol ID
- MS-599-2025
- Status last verified
- Jan 2026
- First submitted
- 21 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Suprapubic Transverse Incision With Rectus Release for Upper Peritoneal Access): A Novel Dual-Plane Technique for Abdominal Wall Incision in Complex Gynecological Surgery
- ClinicalTrials.gov ID
- NCT07373886
- Acronym / sponsor ID
- MS-599-2025
- Conditions
- Post-Op Complication
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 28 Jan 2026 (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.
This study aims to evaluate the clinical effectiveness, anatomical benefits, and postoperative outcomes of the STIRRUP incision (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal Access) by comparing outcomes with historically established benchmarks and published data from traditional abdominal wall incisions used in complex gynecologic surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique | Experimental | Procedure: STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) techniqueSkin incision: A low curvilinear transverse incision will be made 2-3 cm above the pubic symphysis, corresponding to the Pfannenstiel site. Subcutaneous dissection: The subcutaneous tissue will be elevated between Scarpa's fascia and the anterior rectus sheath for approximately 10-12 cm cephalad. Anterior rectus sheath incision: A transverse incision will be made in the anterior rectus sheath approximately 10-12 cm above the pubis, parallel to the skin incision. The linea alba will not be divided, thereby preserving midline fascial integrity. Rectus muscle separation: Beneath the fascial window, the rectus muscles will be separated bluntly at the midline, as in the Pfannenstiel approach, to expose the posterior sheath and peritoneum. No transection of muscle fibers will be performed. Peritoneal entry: The peritoneum will be opened sharply under direct vision. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients aged 18-65 years
- Indication for open gynecologic surgery for benign or borderline pelvic or abdominopelvic masses
- Body Mass Index (BMI) ≥ 18 kg/m²
- Willing and able to provide informed consent and attend follow-up
- Mass size between 15-30 cm, which is considered optimal for the STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique due to the balance between exposure and minimal morbidity
Key exclusion criteria (11 listed)
- Malignant tumors requiring upper abdominal visceral resection (liver, spleen, diaphragm)
- Emergency surgery
- Previous complex abdominal wall reconstruction with mesh
- Contraindication to general anesthesia
- Masses extending to the xiphisternum or measuring >30 cm
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 |
|---|---|---|
| STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) techniqueSkin incision: A low curvilinear transverse incision will be made 2-3 cm above the pubic symphysis, corresponding to the Pfannenstiel site. Subcutaneous dissection: The subcutaneous tissue will be elevated between Scarpa's fascia and the anterior rectus sheath for approximately 10-12 cm cephalad. Anterior rectus sheath incision: A transverse incision will be made in the anterior rectus sheath approximately 10-12 cm above the pubis, parallel to the skin incision. The linea alba will not be divided, thereby preserving midline fascial integrity. Rectus muscle separation: Beneath the fascial window, the rectus muscles will be separated bluntly at the midline, as in the Pfannenstiel approach, to expose the posterior sheath and peritoneum. No transection of muscle fibers will be performed. Peritoneal entry: The peritoneum will be opened sharply under direct vision. | Procedure or surgery | STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique |
Primary outcome
Postoperative seroma formation
Time frame: within the postoperative or follow-up period (6 months)
clinically detectable subcutaneous fluid collection at the incision site, confirmed clinically and/or by ultrasound when indicated.
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 28 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique in people with Post-Op Complication, run by Cairo University.
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 5 inclusion and 11 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: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Postoperative seroma formation (time frame: within the postoperative or follow-up period (6 months)). 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 28 Jan 2026.