Comparative clinical trail of surgical microscope versus medical loupes in primary cleft palate surgery

Comparative clinical trail of surgical microscope versus medical loupes in primary cleft palate surgery - SOLPS

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

DRKS

Registry ID

DRKS00013046

Enrollment

Registered

2017-11-21

Start date

2017-09-01

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

Q35.5

Interventions

Group 1: Cleft palate surgery by using medical loupes Group 2: Cleft palate surgery by using a surgical microscope

Eligibility

Sex/Gender

All

Age

4 Months to 36 Months

Inclusion criteria

Inclusion criteria: Patients with a complete cleft lip and palate as well as patients with an isolatetd cleft palate before operation, after a verbal and written consent of their parents respectively legal guardians

Exclusion criteria

Exclusion criteria: No verbal or written consent of the patient's legal guardians/parents. Patients with compromised wound healing conditions or known wound healing disorders, coagulopathy or immunological primary disease. Children under the age of four months or older than 36 months.

Design outcomes

Primary

Measure	Time frame
The occurrence of postoperative palatal fistulas as well as their exact anatomical classification within 6 months postoperatively is defined as the primary outcome indicator to analyze the success and efficacy of two different optical aids (surgical microscope versus medical loupes) within the same operational procedure on children with cleft palate at the age of 4 to 36 months. A preoperative randomized patient allocation determines the choice of optical aid used during the operation. To measure the benefit of a surgical high resolution microscope in comparison to the established method using medical loupes the exact type of the palate cleft is assessed preoperatively and during routinely performed postoperative examinations at day 10 (removal of sutures), follow-up months 3 and 6 the occurrence of a palatal fistula is evaluated using the Pittsburgh Classification for oronasal fistulas (Losee et al., 2009; Smith et al., 2007). During the inpatient stay (usually one day preoperatively until 5th day postoperatively) detailed clinical examinations on lokal wound condititions and vital signs (i.e. blood pressure, heart rate, temperature) are evaluated daily. Optional laboratory tests are performed according to the general condition of the patient. The use of the surgical microscope in the practiced operation method is as well documented as the use of loupes in the standard operation procedure.	—

Measure

Time frame

The occurrence of postoperative palatal fistulas as well as their exact anatomical classification within 6 months postoperatively is defined as the primary outcome indicator to analyze the success and efficacy of two different optical aids (surgical microscope versus medical loupes) within the same operational procedure on children with cleft palate at the age of 4 to 36 months. A preoperative randomized patient allocation determines the choice of optical aid used during the operation. To measure the benefit of a surgical high resolution microscope in comparison to the established method using medical loupes the exact type of the palate cleft is assessed preoperatively and during routinely performed postoperative examinations at day 10 (removal of sutures), follow-up months 3 and 6 the occurrence of a palatal fistula is evaluated using the Pittsburgh Classification for oronasal fistulas (Losee et al., 2009; Smith et al., 2007). During the inpatient stay (usually one day preoperatively until 5th day postoperatively) detailed clinical examinations on lokal wound condititions and vital signs (i.e. blood pressure, heart rate, temperature) are evaluated daily. Optional laboratory tests are performed according to the general condition of the patient. The use of the surgical microscope in the practiced operation method is as well documented as the use of loupes in the standard operation procedure.

—

Secondary

Measure	Time frame
Interim evaluation and termination criterion: a first evaluation of the study is planned after 6 month, a second one after one year.	—

Countries

Germany

Contacts

Public ContactAnne Klausing

Klinik und Polklinik für Mund-, Kiefer- und Plastische Gesichtschirurgie

anne.klausing@ukb.uni-bonn.de0228-287 15203

Outcome results

None listed

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