跳至主要内容
临床试验/CTRI/2024/04/065961
CTRI/2024/04/065961尚未招募4 期

To assess and compare the outcomes of tail of parotid ligation with circumferential sutures versus 2-Octyl-cyanoacrylate glue application in patients undergoing neck dissection for squamous cell carcinoma of oral cavity - a prospective comparative study

Department of Oral and Maxillofacial Surgery1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年5月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
入组人数
40
试验地点
1
主要终点
• To evaluate the outcome of tail of parotid ligation with circumferential sutures and 2- Octyl- cyanoacrylate glue in prevention of sialocele and salivary fistula

研究概览

简要总结

To Assess and Compare the outcomes of tail of parotid ligation with circumferential sutures versus 2-Octyl-cyanoacrylate glue application in patients undergoing neck dissection for Squamous cell carcinoma of oral cavity .

 INTRODUCTION:-

 Head and neck cancer remains a significant global public health problem and with the presence of cervical lymph node metastasis it is associated with increased morbidity and diminished overall survival rate. So effective management of neck leads to improved disease specific and overall survival rate in Oral squamous cell carcinoma cases. Neck dissection is a surgical procedure performed in treating head and neck cancer patients with or without cervical nodal neck metastasis. Depending on the location and extent of tumor the type of neck dissection and its complications varies.

During a neck dissection many surgeons will include the parotid tail within the superior extent of the dissection. The transected portion of the parotid gland might be at risk of causing a sialocele and subsequent salivary fistula post neck dissection. Post-operative sialocele and salivary fistula formation is a frequent complication following major head and neck cancer management with incidence varying from 5 to 20% in the literature.

Salivary fistulas result in significant morbidity for the patient, increasing the length of hospital stay, risk of readmission, need for adjuvant procedures, and perhaps most importantly, often delaying the time to adjuvant therapy which compromises oncologic outcomes other risk factors such as preoperative radiation with or without chemotherapy, poor nutritional status, co-morbidities, may also influence the likelihood of fistula formation. Sometimes iatrogenic trauma to parotid gland may results in extravasation of saliva in the soft tissues with subsequent formation of sialoceles, cutaneous fistulas or cysts of the salivary duct.

With an understanding of the anatomical and physiologic constraints an extra barrier over the parotid gland can reduce the incidence of postoperative salivary fistula formation. Parotid ligation using vicryl and chromic sutures have been tried in the past but the results are not to that extent. Some studies have used natural (i.e. fibrin-based sealants) for parotid ligation but fibrin based products offer greater pliability but reduced adhesion and stiffness which led to post operative fistula formations. While most surgeons are aware of the demonstrated efficacy of surgical sealants in cutaneous surgical incision closure, their utility in other surgical sites is often less well recognized. Synthetic sealants provide greater stiffness and adhesion with minimal elasticity and tissue toxicity. So in this study we are using a synthetic sealant n octyl cyanoacrylate for parotid ligation versus circumferential sutures to assess and compare the outcomes in patients undergoing neck dissection for management of oral squamous cell carcinoma.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
None

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • 1.Patients histopathologically diagnosed with ‘Oral Squamous Cell Carcinoma’ 2.Patients Fit to undergo surgery without any other comorbidities.
  • 3.Patients who have not underwent any previous salivary gland surgical procedures and radiation therapies.

排除标准

  • 1.Patients who had undergone radiotherapy /chemotherapy.
  • 2.Patients who have been operated earlier for Oral Squamous Cell Carcinoma and underwent neck dissection.
  • 3.Patients who doesn’t require neck dissection procedure .
  • 4.Patients who are unfit for surgery.

结局指标

主要结局

• To evaluate the outcome of tail of parotid ligation with circumferential sutures and 2- Octyl- cyanoacrylate glue in prevention of sialocele and salivary fistula

时间窗: 6 months

次要结局

  • To evaluate the length of the hospital stay.(To evluate the drain collection)

研究者

申办方类型
Research institution and hospital
责任方
Principal Investigator
主要研究者

Anukula Hema Sai Lakshmi

Department of Oral and maxillofacial Surgery, Sharad Pawar dental college

研究点 (1)

Loading locations...

相似试验