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临床试验/CTRI/2025/09/094438
CTRI/2025/09/094438尚未招募不适用

An Audit of Retrospective Database on Esophagectomy Surgeries at a Tertiary Care Cancer Hospital in India.

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 1,140 人开始时间: 2025年9月22日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,140
试验地点
1
主要终点
To find out the incidence of postoperative complications (Clavein-Dindo 3a and above) till discharge across all types of esophagectomies performed at a single-centre tertiary care cancer hospital.

研究概览

简要总结

Esophageal cancers account for the seventh most common type of cancer worldwide. ¹Esophagectomy is the modality of treatment for locally-advanced esophageal cancers in many patients. The ERAS guidelines strongly recommend smoking and alcohol abstinence, and low level of recommendation for investigations such as CPET. Nutrition is an important aspect in esophagectomy surgeries as many patients are malnourished, often requiring additional support. 2 There is moderate evidence that minimally invasive surgeries are associated with less blood loss, shorter hospital stay and reduced pain. ERAS guidelines also comment on optimum fluid administration and maintenance of normothermia. Intraoperatively, one-lung ventilation with permissible hypercapnia is strongly recommended. They also strongly recommend optimum pain management with thoracic epidural, paravertebral block and co-analgesics such as NSAID’s and acetaminophen.2

The Esophageal Complications Consensus group (ECCG) has provided a list of the most common complications occurring in esophagectomy surgeries that categorizes a wide range of potential complications, organized by the specific body system affected. These complications, which include issues like pneumonia and pleural effusions in the pulmonary system, cardiac arrest and dysrhythmias, gastrointestinal leaks and infections, and various other systemic problems, often require further medical intervention, prolonged hospital stays, or specialized management. 3 They also obtained prospective data for over 2700 patients across 24 centres in 14 countries over 2 years. 56.2% surgeries were performed in the distal esophagus with more than half of them receiving some form of treatment prior to surgery. The incidence of complications was found to be 59%, with pneumonia contributing 14.6% and anastomotic leak 14.5% The readmission rates were 11.2% and 30 and 90-day mortality rates were 2.4% and 4.5%, respectively. 4

Studies conducted across the globe aim at estimating the incidence of complications based on ECCG. Netherlands reported 65% of patients (1046 of 1617) with postoperative complications, with 29% (468 patients) experiencing a major complication. The most prevalent complications observed were pneumonia (21%), esophago-enteric leak from the anastomosis, staple line, or localized conduit necrosis (19%), and atrial dysrhythmia (15%). The associated 30-day mortality rate was 1.7%. 5 The Dutch Upper Gastrointestinal Cancer Audit also analysed 4096 patients and concluded that pulmonary complications and anastomotic leakage are the most impactful adverse events following surgery, significantly contributing to postoperative mortality (44.1% and 30.4% attributable risk, respectively), prolonged hospital stays (31.4% and 30.9% attributable risk) and hospital readmissions (7.3% and 14.7% attributable risk). Additionally, anastomotic leakage is the primary driver for reoperations, accounting for 47.1% of such instances. Other complications have a comparatively minor effect on these outcomes. 6 The main complications identified in a study in New Zealand spanning 25 years include POPC’s and anastomotic leaks. 7

Hence, we wanted conduct and audit based on the data at our centre as we conduct over 150 esophageal surgeries per year. This would help in improving the quality of treatment in such complex surgeries in India. This will be a single-centre audit of over 1000 patients who underwent elective esophagectomy from 2017-2024.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • ALL ADULT PATIENTS UNDERGOING ELECTIVE ESOPHAGECTOMY SURGERIES AT TMH.

排除标准

  • Emergency surgeries Inoperability after exploration Performing any other procedure in addition to esophagectomy Missing data.

结局指标

主要结局

To find out the incidence of postoperative complications (Clavein-Dindo 3a and above) till discharge across all types of esophagectomies performed at a single-centre tertiary care cancer hospital.

时间窗: As we have a database of esophagectomy surgeries, the data will be assessed immediately after approval of registration.

次要结局

  • 1. To determine the pre-operative & intraoperative factors that could contribute towards postoperative complications in esophagectomy surgeries.(2. To determine intraoperative sentinel events (arrhythmias, need for vasopressors; desaturation needing intervention).)

研究者

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

Dr Swapnil Parab

Tata Memorial Centre, Parel, Mumbai

研究点 (1)

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