Unilateral Cleft Repair in One Surgery With Pure Primary Healing

NCT ID: NCT04108416

Last Updated: 2019-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-01

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Retrospective analysis of the current surgical method to repair unilateral cleft lip and palate malformations at our centre

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cleft Lip and Palate

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cleft lip and palate repair

The intervention is the currently used cleft lip and palate repair technique at the University Hospital Basel and University Childrens Hospital Basel

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* newborn patients with complete unilateral cleft lip and palate

Exclusion Criteria

* with associated syndrome
* previous lip/ palate repair
* previous presurgical orthopaedics other than passive palatal plate
Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Basel, Switzerland

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Benito Benitez

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Benitez Benito, MD DMD

Role: PRINCIPAL_INVESTIGATOR

University of Basel and University Hospital Basel

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Universitätsspital Basel

Basel, , Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

References

Explore related publications, articles, or registry entries linked to this study.

Aduss H, Pruzansky S. Width of cleft at level of the tuberosities in complete unilateral cleft lip and palate. Plast Reconstr Surg. 1968 Feb;41(2):113-23. doi: 10.1097/00006534-196802000-00003. No abstract available.

Reference Type BACKGROUND
PMID: 4873510 (View on PubMed)

Berkowitz S, Duncan R, Evans C, Friede H, Kuijpers-Jagtman AM, Prahl-Anderson B, Rosenstein S. Timing of cleft palate closure should be based on the ratio of the area of the cleft to that of the palatal segments and not on age alone. Plast Reconstr Surg. 2005 May;115(6):1483-99. doi: 10.1097/01.prs.0000161673.31770.23.

Reference Type BACKGROUND
PMID: 15861051 (View on PubMed)

Mueller AA, Zschokke I, Brand S, Hockenjos C, Zeilhofer HF, Schwenzer-Zimmerer K. One-stage cleft repair outcome at age 6- to 18-years -- a comparison to the Eurocleft study data. Br J Oral Maxillofac Surg. 2012 Dec;50(8):762-8. doi: 10.1016/j.bjoms.2012.02.002. Epub 2012 May 1.

Reference Type BACKGROUND
PMID: 22551772 (View on PubMed)

Brief J, Behle JH, Stellzig-Eisenhauer A, Hassfeld S. Precision of landmark positioning on digitized models from patients with cleft lip and palate. Cleft Palate Craniofac J. 2006 Mar;43(2):168-73. doi: 10.1597/04-106.1.

Reference Type BACKGROUND
PMID: 16526922 (View on PubMed)

Benitez BK, Brudnicki A, Surowiec Z, Singh RK, Nalabothu P, Schumann D, Mueller AA. Continuous circular closure in unilateral cleft lip and plate repair in one surgery. J Craniomaxillofac Surg. 2022 Jan;50(1):76-85. doi: 10.1016/j.jcms.2021.07.002. Epub 2021 Aug 3.

Reference Type DERIVED
PMID: 34896005 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PurePrimary

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Domperidone in Refractory Gastroparesis
NCT00760461 TERMINATED PHASE2
Tolerability of Enteral NAC in Infants
NCT06260566 NOT_YET_RECRUITING PHASE1