跳至主要内容
临床试验/CTRI/2024/07/070222
CTRI/2024/07/070222尚未招募Phase 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 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年9月1日最近更新:

试验速览

阶段
Phase 3 4
状态
尚未招募
发起方
入组人数
16
试验地点
1
主要终点
Reconstruction with radial forearm free flap will help in better functional and esthetics outcomes

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • • 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.

排除标准

  • • 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.

结局指标

主要结局

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

时间窗: Assesment will be done 7 days,1 month,3 month after surgery

次要结局

未报告次要终点

研究者

发起方
Datta Meghe Institute of Higher Education and Research
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Dr Imran Solanki

Datta Meghe Institute of Higher Education and Research, Wardha

研究点 (1)

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