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Clinical Trials/CTRI/2024/07/070222
CTRI/2024/07/070222Not yet recruitingPhase 3 4

Comparative evaluation of functional and esthetic outcomes in reconstruction of Commissure of Mouth with radial forearm free flap with and without Palmaris Longus Tendon in patients being operated for squamous cell carcinoma of Buccal Mucosa and lip

Datta Meghe Institute of Higher Education and Research1 site in 1 country16 target enrollmentStarted: September 1, 2024Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
16
Locations
1
Primary Endpoint
Reconstruction with radial forearm free flap will help in better functional and esthetics outcomes

Study Overview

Brief Summary

Introduction-: Our experience demonstrates the effectiveness of radial forearm flap (RFF) in lip deformity and buccal mucosa restorations, both with and without Palmaris Longus Tendon. The best therapy after large oncologic resections is with microvascular free flaps. The tissue produced by the Radial Forearm Free Flap is thin, malleable, and well-vascularized. It guarantees less morbidity at the donor site because it is harvested pedicled on the radial artery. Successful vascularization is facilitated by microvascular anastomosis. With a high success rate, RFFF provides good functional and cosmetic results for a range of intraoral reconstructions.

Need of the study This study will help evaluate the functional and aesthetic results of reconstructing the lip and buccal mucosa in cases with squamous cell carcinoma. Long-term preservation of the vertical lip height and lip supports is carried out by the Palmaris Longus Tendon, which functions as a sling over which the flap is elevated.

Aim: The study is design to compare & evaluate functional & estheticoutcomes in reconstruction of Commissure of Mouth with radial forearm free flap with & without Palmaris Longus Tendon in patients being operated for squamous cell carcinoma of Buccal Mucosa and lip.

Materials and Method**:**  Prospective Observational study. The clinical study will be performed at the Department of Oral and Maxillofacial Surgery, Siddharth Gupta Memorial Cancer Hospital, Sawangi, Wardha, Maharashtra. After taking approval from the IEC, DMIHER (DU) and explaining detailed treatment protocol to the patients. Procedure will be performed in patients which are histopathological proven. Detailed Case History,Clinical Examination,Past medical, dental history, general personal information, and then biopsy will be performed. In patient with biopsy proven of Squamous Cell Carcinoma, further be subjected to Radiographic Examination (CT SCAN) for knowing the extent of lesion, metastasis of lymph node. Patients with Biopsy proven  and those who are meeting the inclusion criteria will be included in the study after obtaining detailed informed consent.

2 group in which 8 patients with Radial forearm free flap with Palmaris Longus Tendon & 8 without Palmaris Longus Tendon in which functional outcomes like Drooling, Swallowing, Speech & Esthetics outcomes Smile, Lip Competence & Commissural ends will be assessed.

Study Design

Study Type
Interventional
Allocation
Randomized
Masking
Participant Blinded

Eligibility Criteria

Ages
18.00 Year(s) to 85.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • • Biopsy proven case of Squamous Cell Carcinoma of buccal mucosa and lip.
  • • All patient with carcinoma of commissure of mouth.
  • • All patient with carcinoma of Buccal Mucosa and lip.
  • • All patients who have shown positive test on Allen test , as a pre-requisite to Radial Forearm Free Flap with or without Palmaris Longus Tendon.

Exclusion Criteria

  • • Any carcinoma ( verrucous carcinoma, basal cell carcinoma ,etc) other than squamous cell carcinoma.
  • • Patient who have undergone surgery, or chemotherapy.
  • • Patient who has undergone radiotherapy.
  • • Patient who are lost to follow up.
  • • Patient who are not fit for surgery.
  • • All patient not willing for RADIAL FOREARM FREE FLAP.

Outcomes

Primary Outcomes

Reconstruction with radial forearm free flap will help in better functional and esthetics outcomes

Time Frame: Assesment will be done 7 days,1 month,3 month after surgery

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Datta Meghe Institute of Higher Education and Research
Sponsor Class
Private medical college
Responsible Party
Principal Investigator
Principal Investigator

Dr Imran Solanki

Datta Meghe Institute of Higher Education and Research, Wardha

Study Sites (1)

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