NCT07143058

Brief Summary

Different Modalities of Flaps used in Head and Neck Reconstructions in oral cancer Patients, retrospective study Study design: This study will be conducted in a Retrospective study with prospective collective data. At General Surgery Department of Sohag University Hospital in the period between June 2020 to June 2025. Data base will be gathered, reviewed, and consequently will be analyzed. Study population: The study will include patients presented post operative Head and Neck cancer Resection and Reconstruction with flap during the period of the study, analysis of the clinical presentation, follow up size, color, regeneration skin, early and late complication and a defect appear Inclusion criteria: All patients with head and neck Reconstruction on oral cancer patients

  1. 1.Age: any age.
  2. 2.Sex: males and females.
  3. 3.Cooperative, mentally healthy.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
1mo left

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress90%
Jun 2025Jun 2026

Study Start

First participant enrolled

June 12, 2025

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 27, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 12, 2026

Last Updated

August 27, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

June 29, 2025

Last Update Submit

August 26, 2025

Conditions

Keywords

Different Modalities of Flaps used in Head and Neck Reconstructions in oral cancer Patients, retrospective study

Outcome Measures

Primary Outcomes (8)

  • Hospital stay

    how many days staying in hospital post sugery of reconstrucion of head and neck

    Up to 1 week

  • incidence of infection

    incidence of wound infection , discharge pus ,edema ,how many days to releved by antibiotic

    Up to 1 week

  • incidence of Bleeding

    incidence of bleeding and hematoma under flap which cause compromise of local flap vascularity by inducing vasospasm, stretching the sub dermal plexus, or separating the flap from the surface of the recipient site

    Up to 1 week

  • incidence of Ischemia

    incidence of ischemia of flap as dark skin , Pale, cold, delayed capillary refill, no bleeding on needle prick.

    Up to 1 week

  • Wound Dehiscence

    : The surgical wound may separate, exposing the flap

    Up to 4 weeks

  • Fistula Formation

    An abnormal connection can form between the flap and other structures, like the oral cavity or pharynx , clinically leakage and ct neck e iv contrast or mri show track of fistula

    Up to 4 weeks

  • Number of participants with fibrosis

    may occur fibrosis between flap and beside structures of oral cavity ,make limitation of movement of mandible , mri image show fibrosis

    Up to 8 weeks

  • questionnaire quality of life of Washington university : Health-related quality of life (HRQOL) is an important outcome parameter following treatment for head and neck cancer.

    . Version 4 of the UW-QOL questionnaire consists of 12 single question domains, these having between 3 and 6 response options that are scaled evenly from 0 (worst) to 100 (best) according to the hierarchy of response. The domains are pain, appearance, activity, recreation, swallowing, chewing, speech, shoulder, taste, saliva, mood and anxiety. Another question asks patients to choose up to three of these domains that have been the most important to them.There are also three global questions, one about how patients feel relative to before they developed their cancer, one about their health-related QOL and one about their overall QOL..Scoring of UW-QOL domains The UW-QOL has domains based upon discrete ordinal responses. Scoring is scaled to so that a score of 0 represents the worst possible response, and a score of 100 represents the best possible response .http://www.hancsupport.com/professionals/quality-life/qol-questionnaires/uw-hrqol/uw-qol-v4-translations

    1 year after surgery

Interventions

Follow up and quality of life of reconstruction flaps in head and neck

All types of flaps in oral cancer reconstruction

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients with oral cancer done flap reconstruction

You may qualify if:

  • All patients with head and neck Reconstruction on oral cancer patients ,Cooperative and mentally healthy

You may not qualify if:

  • Mentally or psychologically disordered patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag university faculty of medicine

Sohag, Egypt

Location

MeSH Terms

Conditions

Mouth Neoplasms

Condition Hierarchy (Ancestors)

Head and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Resident in general surgery department

Study Record Dates

First Submitted

June 29, 2025

First Posted

August 27, 2025

Study Start

June 12, 2025

Primary Completion (Estimated)

June 12, 2026

Study Completion (Estimated)

June 12, 2026

Last Updated

August 27, 2025

Record last verified: 2025-08

Locations