The efficacy of SI-AntiSlip Device for Laparoscopic Gynecologic Surgery

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

TCTR

Registry ID

TCTR20250922005

Enrollment

160

Registered

2025-09-22

Start date

2025-12-01

Completion date

Unknown

Last updated

2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Patient positioning with device during laparoscopic gynaecologic surgery,Patient positioning without SI-anti slip device (standard method)

Experimental Device,Active Comparator Device

SI-anti slip Device,Standard Positioning (No SI-anti slip Device)

Eligibility

Sex/Gender

Female

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age 18 years or older - Undergoing laparoscopic gynaecologic surgery expected to last 2 hours or longer - No pre-existing neurological deficits (numbness or weakness in arm, leg, or perineum) - Able and willing to provide informed consent

Exclusion criteria

Exclusion criteria: - Surgeon refuses to use SI- Anti Slip device - Conversion to laparotomy during surgery - Operation completed in less than 2 hours

Design outcomes

Primary

Measure	Time frame
Patient sliding distance (cm) Intraoperative (baseline, 1 hr, 2 hr, end of surgery) Measured in centimeters at acromion process using ruler/tape at 4 time points (supine baseline, Trendelenburg 1 hr, Trendelenburg 2 hr, closure in supine)	—

Secondary

Measure	Time frame
Neurological complications (numbness/weakness in extremities or perineum) Postoperative day 0, 7, 30 Postoperative physical exam and patient interview, recorded in CRF at day 0, day 7, day 30	—

Countries

Thailand

Contacts

Public ContactNumpueng Inthaphoe

Faculty of Medicine Siriraj Hospital, Mahidol University

numpueng.inh@mahidol.ac.th0614184575

Outcome results