NCT07373886

Brief 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 wall incisions used in complex gynecologic surgery.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started Feb 2026

Status
not yet 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 Progress29%
Feb 2026Dec 2026

First Submitted

Initial submission to the registry

January 21, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 28, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

February 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

January 21, 2026

Last Update Submit

January 21, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • Postoperative seroma formation

    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)

Study Arms (1)

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.

Procedure: STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique

Interventions

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.

STIRRUP (Suprapubic Transverse Incision with Rectus Release for Upper Peritoneal access) technique

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Postoperative Complications

Interventions

Methods

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics and Gynecology

Study Record Dates

First Submitted

January 21, 2026

First Posted

January 28, 2026

Study Start

February 1, 2026

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01