Comparison of two different access sheaths in endoscopic kidney stone surgery

Comparison of a Bendable Suction Ureteral Access Sheath with a traditional access Sheath in retrograde renal surgery (RIRS) as a double-blind clinical trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20260209068808N1

Enrollment

Registered

2026-02-18

Start date

2026-02-13

Completion date

Unknown

Last updated

2026-06-01

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

Conditions

kidney stone.

Interventions

Intervention 1: Intervention group: Method Description: In this group, a new access sheet with high flexibility and active suction system is used. This technology allows better access to kidney stones

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: RIRS candidate patients Age between 18 and 65 years Absence of active urinary tract infection

Exclusion criteria

Exclusion criteria: History of previous kidney surgery Coagulation disorders Active urinary tract infection

Design outcomes

Primary

Measure	Time frame
Time recorded by the surgical team (duration of surgery from start to finish). Timepoint: Preoperative (tests, imaging, examination), intraoperative (surgery duration, instrument type, bleeding rate), and postoperative (pain, urinary symptoms, stone residue) assessments are recorded by an evaluator. Data recording is performed only at the same times as routine clinical care. Method of measurement: Recording the time from the start to the end of the surgery by the surgical team.;Post-surgery imaging results (no remaining stones or stone fragments less than 4 mm in size after surgery). Timepoint: Post-surgical. Method of measurement: Post-surgical imaging evaluation (CT Scan or ultrasound).;Postoperative complications (the occurrence of any postoperative complication that requires medical intervention). Timepoint: postoperative. Method of measurement: Recording of complications such as infection, bleeding, and damage to the urinary tract by the medical team.;Medical expenses. Timepoint: post surgical. Method of measurement: Recording the costs of surgery, hospitalization, medications, and post-operative care.	—

Measure

Time frame

Time recorded by the surgical team (duration of surgery from start to finish). Timepoint: Preoperative (tests, imaging, examination), intraoperative (surgery duration, instrument type, bleeding rate), and postoperative (pain, urinary symptoms, stone residue) assessments are recorded by an evaluator. Data recording is performed only at the same times as routine clinical care. Method of measurement: Recording the time from the start to the end of the surgery by the surgical team.;Post-surgery imaging results (no remaining stones or stone fragments less than 4 mm in size after surgery). Timepoint: Post-surgical. Method of measurement: Post-surgical imaging evaluation (CT Scan or ultrasound).;Postoperative complications (the occurrence of any postoperative complication that requires medical intervention). Timepoint: postoperative. Method of measurement: Recording of complications such as infection, bleeding, and damage to the urinary tract by the medical team.;Medical expenses. Timepoint: post surgical. Method of measurement: Recording the costs of surgery, hospitalization, medications, and post-operative care.

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Secondary

Measure	Time frame
Quality of life of patients. Timepoint: Before surgery, 3 months after. Method of measurement: Standard Quality of Life Questionnaire (SF-36).	—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactParsaasadi

Iran University of Medical Sciences

parsaasadi75@gmail.com+98 21 8881 6923

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026