NCT03890783|Completed
Functional Results of Soft Palate Free Flap Reconstruction
RECaVoLL
Evaluation of Functional Results After Surgery of Oropharyngeal Cancers With Soft Palate With Free Flap Reconstruction
Loading search results
RECaVoLL
Evaluation of Functional Results After Surgery of Oropharyngeal Cancers With Soft Palate With Free Flap Reconstruction
Sponsor study identifier
Secondary identifiers
OTHER · ID-RCB
observational
29
1 country
1
Study Start
February 27, 2019
Actual (reported)Primary Completion
March 11, 2020
Actual (reported)Study Completion
March 11, 2020
Actual (reported)The oropharynx is a complex anatomical structure necessary for nasal breathing, swallowing and phonation. The removal of oropharyngeal cancers can lead to sequelae, particularly in the case of resections affecting the soft palate. The main sequelae are represented by rhinolalia and swallowing disorders with nasal regurgitation. The treatment of oropharyngeal tumors is based on primary surgery or radiotherapy, but tumors of the soft palate are often treated by radiotherapy or radio-chemotherapy first. Surgery is often kept for relapses, because it is considered to lead to important sequelae. However, chemoradiotherapy of the oropharynx is also responsible for acute toxicities, and late sequelae can be frequent and important. Recent publications tend to show that primary surgery would give better survival rates compared to radiotherapy, particularly in advanced stages, including viro-induced cancers. In addition, primary surgery can reduce the dose of radiation delivered to the oropharynx and thus reduce its long-term toxicity. It is currently possible to reconstruct a loss of substance after surgery of oropharyngeal cancers, including the soft palate by using free flaps, limiting the postoperative sequelae usually observed without reconstruction. There is little data on reconstructions of the soft palate, their sequelae and their impact on the quality of life.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 11, 2020
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 30, 2019
Actual (reported)February 27, 2019
Actual (reported)March 26, 2019
Actual (reported)March 11, 2020
Actual (reported)March 11, 2020
Actual (reported)Evaluation of phonation quality at least 12 months after the end of external radiotherapy.
Self-evaluation by completion of the Voice Handicap Index questionnaire, in its 30 items version. For self evaluation of phonation using the Voice Handicap Index 30 (VHI 30) questionnaire: The VHI is rated on 120 points. For each question a score from 0 to 4 is assigned (0 = never, 1 = almost never, 2 = sometimes, 3 = almost always, 4 = always). Its three sub-scales allow to establish an emotional score E out of 40, a physical score P out of 40 and a Functional score F out of 40. The total score can therefore be between 0 and 120 points. The interpretation of this test is done by comparing the sub-scores and the total score obtained with the averages values of these sub-scores and total score.
12 months
Hetero evaluation of phonation quality at least 12 months after the end of external radiotherapy
12 months
Patients after surgery of oropharyngeal cancers with soft palate with free flap reconstruction and adjuvant radiotherapy
Evaluation of phonation quality by : * Self-evaluation: completion of the Voice Handicap Index questionnaire, in its 30 items version * Hetero-evaluation: reading and recording of 2 texts, and notation by 3 practitioners using the grade, rough, breathy, asthenic, strained (GRBAS) scale, to evaluate the occurrence and the gravity of rhinolalia
Evaluation of swallowing quality by: * Self-evaluation: completion of the Deglutition Handicap Index questionnaire * Hetero-evaluation: nasofibroscopy to evaluate the occurrence of aspiration and nasal regurgitation
Patients over 18 years of age, with oropharyngeal tumor requiring surgical management with excision of part or all of the soft palate, with free flap reconstruction
Groupement Hospitalier Lyon Nord - Hospices Civils de Lyon
Lyon, 69004, France
29 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2019
First Posted
March 26, 2019
Study Start
February 27, 2019
Actual (reported)Completion of the European Organization for Research and Treatment of Cancer Quality of Life questionnaire (EORTC QLQ - C30) and the EORTC QLQ - H\&N35 questionnaires
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
March 11, 2020
Actual (reported)Study Completion
March 11, 2020
Actual (reported)Last Updated
October 14, 2020
Record last verified: 2020-10
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.
Source retrieved: