- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07373886
Suprapubic Transverse Incision With Rectus Release for Upper Peritoneal Access): A Novel Dual-Plane Technique for Abdominal Wall Incision in Complex Gynecological Surgery
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique
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. |
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
within the postoperative or follow-up period (6 months)
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MS-599-2025
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Post-Op Complication
-
Rigshospitalet, DenmarkCompletedComplication,Postoperative | Post-Op ComplicationDenmark
-
University of Alabama at BirminghamCompletedPost-Op ComplicationUnited States
-
Riphah International UniversityCompletedPost-Op ComplicationPakistan
-
Alexa CraigMaineHealthCompletedPost-Op ComplicationUnited States
-
Future University in EgyptRecruitingPost-Op ComplicationEgypt
-
Centre Hospitalier Régional Metz-ThionvilleCompletedPost-Op ComplicationFrance
-
NYU Langone HealthCompleted
-
Rothman Institute OrthopaedicsUnknown
-
Assiut UniversityCompleted
-
Cairo UniversityCompletedPost-Op Complication | Post Colo- Rectal Surgeries | Colo -Rectal SurgeriesEgypt