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Not yet recruiting NCT07373886

Suprapubic Transverse Incision With Rectus Release for Upper Peritoneal Access): A Novel Dual-Plane Technique for Abdominal Wall Incision in Complex Gynecological Surgery

No phase Interventional Post-Op Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique.
Who it may be relevant to
Registry conditions: Post-Op Complication. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure 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 divi

Primary outcome measures

  • Postoperative seroma formation [Time frame: within the postoperative or follow-up period (6 months)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07373886 · MS-599-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗