[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100538146":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":29,"locations":35,"responsibleParty":52,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":58,"acronym":10,"eligibilityCriteria":59,"healthyVolunteers":56,"sex":60,"minAge":61,"maxAge":10,"enrollmentInfo":62,"targetDuration":10,"studyType":65,"phases":10,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":38,"whyStopped":10,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":75,"completionDateStruct":77,"leadSponsor":79,"locationsCount":80},{"fullName":5,"class":6},"Regina Elena Cancer Institute","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Salvage total laryngectomy STL primary suture",null,"Patients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing.The primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)31. It would be preferable for all centers to use a homogeneous pharyngeal suture technique, such as the T-shaped with Connell suture.",[13],"Procedure: Primary suture",{"label":15,"type":10,"description":16,"interventionNames":17},"Salvage total laryngectomy STL primary suture + onlay flap","Patients in both groups will then undergo salvage total laryngectomy STL surgery with primary suturing, but in the patients of the second group, in addition, the positioning of a free\u002Fpedunculated covering flap will also be carried out with the onlay technique. Reconstruction with the onlay technique can be performed using a pedicled pectoralis major myofascial flap or anterolateral thigh myofascial free flap at the surgeon's discretion (pharyngeal suture unchanged). The flap will be positioned with an onlay technique to reinforce the pharyngeal suture and in turn sutured to the prevertebral fascia or residual surrounding tissues.",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":10},"PROCEDURE","Primary suture","The primary suture can be performed according to the different techniques available at the discretion of the surgeon (vertical, horizontal or T-shaped closure, with continuous suture, according to Connell or with detached stitches)",[9,15],[25],{"name":26,"affiliation":27,"role":28},"Raul Pellini, Doctor","IRCCS \"Regina Elena\" National Cancer Institute","PRINCIPAL_INVESTIGATOR",[30],{"name":26,"role":31,"phone":32,"phoneExt":33,"email":34},"CONTACT","06-52664484","+39","raul.pellini@ifo.it",[36],{"facility":37,"status":38,"city":39,"state":39,"zip":40,"country":41,"countryCode":42,"cosmosGeoPoint":43,"geoPoint":48,"contacts":49},"\"Regina Elena\" National Cancer Institute","RECRUITING","Rome","00144","Italy","IT",{"type":44,"coordinates":45},"Point",[46,47],12.51133,41.89193,{"lat":47,"lon":46},[50],{"name":51,"role":31,"phone":32,"phoneExt":10,"email":34},"Pellini Raul, Doctor",{"type":53,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100538146","the-role-of-the-freepedunculated-flap-in-total-laryngectomy-after-chemo-radiotherapy-failure-for-laryngeal-carcinoma-impact-on-the-risk-of-pharyngocutaneous-fistula-pcf-100538146",false,"NCT06287034","The Role of the Free\u002FPedunculated Flap in Total Laryngectomy After (Chemo-)Radiotherapy Failure for Laryngeal Carcinoma: Impact on the Risk of Pharyngocutaneous Fistula (PCF)","Inclusion Criteria:\n\n* Histological confirmation of recurrence\u002Fpersistence of squamous cell carcinoma of the larynx previously subjected to exclusive radiotherapy or concomitant chemo-radiotherapy treatment:\n\n  1. pre (ChT-)RT staging: cT1\u002FT2\u002FT3 N0\u002FN+;\n  2. pre STL staging: rcT1\u002FcT2\u002F Selected cT3 cT4a (extension to thyroid cartilage and\u002For prelaryngeal tissues) N0\u002FN+ (clinically and radiologically).\n* Indication for STL surgery (no pharyngeal mucosal resection);\n* Functional total laryngectomies after radical (chemo-)radiotherapy treatment;\n* Age \\> 18 years;\n* Signature of informed consent and ability to complete in-office questionnaires.\n\nExclusion Criteria:\n\n* STL extended to the pharynx and\u002For total pharyngeal laryngectomies;\n* Extension of the tumor to the pharyngeal mucosa and\u002For massive extra-laryngeal extension;\n* Previous open organ preservation surgery (OPHL).","ALL","18 Years",{"count":63,"type":64},102,"ESTIMATED","OBSERVATIONAL","Multicenter, prospective, randomized study aimed at evaluating the difference in risk of PCF after salvage laryngectomy in two groups of patients: one cohort treated with Total Laryngectomy (LT) with primary suture, a second group treated with LT and reinforcement by flap positioning with onlay technique (PMM, ALT)",[68],"Larynx Carcinoma",[70],"pharyngocutaneous fistula","2026-06-04",{"date":73,"type":74},"2026-06-05","ACTUAL",{"date":76,"type":74},"2023-03-21",{"date":78,"type":64},"2027-09-21",{"name":5,"class":6},1]