A randomized, controlled trial comparing the use of the Endoflator 50® (KARL STORZ SE & CO. KG) to not preheated optic

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00033789

Enrollment

Registered

2024-03-18

Start date

2022-10-01

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

All patients had a planned laparoscopy, most common indications were Uterine myoma, Endometriosis and various gynecological malignancies

Interventions

Group 1: Investigational group: patients in this group will be operated using the Endoflator® 50 (KARL STORZ SE & Co. KG), insufflated carbon dioxide will be heated to body temperature Group 2: Contr

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: • informed consent • Age over 18 years • Indication for laparoscopy • ASA Risk Classification I-II

Exclusion criteria

Exclusion criteria: • No informed consent • Pregnancy. This is validated preoperatively via a pregnancy test (urine), not older than 24 hours • Allergies to the anti-fog agents used • Phemoperitoneum or severe ascites • ASA = III • Duration of operation less than 30 min

Design outcomes

Primary

Measure	Time frame
primary outcome is the severity of fogging of the laparoscopic lens after 1, 10 and 30 min into surgery using a visual analogue scale, the fogging is evaluated by two independent, blinded doctors. This severity is classified on a 10-point visual scale, with 0 representing a completely clear view and 10 representing the greatest possible fogging	—

Secondary

Measure	Time frame
1. Number of cleanings of laparoscopic optic required during surgery with sterile dressing, irrigation or ResoClear® 2. Total time duration of laparoscopy optic cleanings, measured in seconds 3. Duration of surgery in minutes, measured from skin incision to skin suture 4. Intraoperative blood loss measured in milliliters 5. Changes in serum hemoglobin (in g/dl) measured preoperatively and 24 hours postoperatively 6. Duration of hospitalization in days 7. Detection of intraoperative and postoperative complications as well as the recording of transfusions 8. Measurement of CO2 usage in liters during surgery 9. Measurement of irrigation fluid usage in liters during surgery 10. Measurement of the number of trocar punctures including Palmer Point 11. Capture a conversion from laparoscopy to open surgery 12. Change in core body temperature (rectal measurement in C°) preoperative to postoperative 13. Measurement of blood pressure pre- and postoperative (in mmHg) 14. Postoperative Usage of Opiates as Pain Medication 15. Assessment of postoperative pain via a pain questionnaire 24 and 48 hours postoperatively	—

Measure

Time frame

1. Number of cleanings of laparoscopic optic required during surgery with sterile dressing, irrigation or ResoClear® 2. Total time duration of laparoscopy optic cleanings, measured in seconds 3. Duration of surgery in minutes, measured from skin incision to skin suture 4. Intraoperative blood loss measured in milliliters 5. Changes in serum hemoglobin (in g/dl) measured preoperatively and 24 hours postoperatively 6. Duration of hospitalization in days 7. Detection of intraoperative and postoperative complications as well as the recording of transfusions 8. Measurement of CO2 usage in liters during surgery 9. Measurement of irrigation fluid usage in liters during surgery 10. Measurement of the number of trocar punctures including Palmer Point 11. Capture a conversion from laparoscopy to open surgery 12. Change in core body temperature (rectal measurement in C°) preoperative to postoperative 13. Measurement of blood pressure pre- and postoperative (in mmHg) 14. Postoperative Usage of Opiates as Pain Medication 15. Assessment of postoperative pain via a pain questionnaire 24 and 48 hours postoperatively

—

Countries

Germany

Contacts

Public ContactErich-Franz Solomayer

Universitätsklinikum des Saarlandes, Klinik für Frauenheilkunde, Geburtshilfe und Reproduktionsmedizin

bashar.hajhamoud@uks.eu00 49 6841 1628000

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026