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临床试验/CTRI/2025/02/079852
CTRI/2025/02/079852尚未招募不适用

A retrospective analysis of postoperative complications in Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy surgery: [CHERRY (Complications of HipEc suRgeRY)]

Tata Memorial Hospital1 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2025年2月5日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
400
试验地点
1
主要终点
Incidence of Grade 3 & 4 Clavien Dindo Complications and as per Comprehensive

研究概览

简要总结

Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) is a comprehensive treatment option performed for peritoneal surface malignancies (PSM), both primary peritoneal cancers and peritoneal metastasis secondary to colorectal, appendiceal, ovarian, gastric and other malignancies. CRS is performed to treat macroscopic disease and HIPEC is used to treat microscopic residual disease with the intent to treat the PC by a single procedure, CRS comprises the surgical removal of visible tumour from peritoneal surfaces as well as abdomino-pelvic organs. CRS includes a wide spectrum which ranges from excision of a single peritoneal nodule to complete peritonectomy along with multi-visceral resections and up to 3-5 anastomoses. It is followed by HIPEC which involves pumping highly concentrated chemotherapy drugs heated to 41°C - 43°C into the peritoneal cavity. HIPEC can be performed either with closed or open abdominal techniques. The primary disease and institutional protocol dictate the type of HIPEC treatment used in various institutes. The duration of surgery can vary from eight to fifteen hours, with longer duration being the norm rather than an exception.

CRS-HIPEC is a complex procedure with some life-threatening complications in the immediate postoperative period, reported morbidity rates between 12%-60% and a mortality rate of 0.9%-5.8%. The postsurgical complications have been reported as late as 90 d after surgery. Percentage of these complications, morbidity and mortality outcomes varies in different studies and those depends on many factors like primary malignancy, extent of metastasis, patient related factors, perioperative management. Over the years since its introduction in 1980, better patient selection, improvements in surgical techniques, surgical skills and perioperative management strategies, have further reduced the morbidity and improved the survival.

Several studies found reduction of morbidity and mortality over time, stressing the importance of the learning curve principle [3,4,5]. studies like Terence C.Chua et.al. have analysed impact of clinical and treatment-related variables on complications and outcomes, Andrew D. Newton et.al. found in there review study that CRS and HIPEC is performed at experienced high volume centers, can be associated with long term survival with acceptable morbidity and mortality rates. Our institute doing CRS-HIPEC surgeries since 2015 with optimal number of surgeries per year, hence decided to study on the complications in CRSHIPEC surgery and impact of risk factors associated with morbidity and mortality

For the purpose of description, these complications have been grouped into Medical complications like Respiratory, Cardiovascular, Renal and pelvicalyceal system, Central nervous system complications like delirium, Hepatobilliary and gastrointestinal, Hematological, Sepsis : cause by central line, foleys catheter etc Venous thromboembolism : pulmonary embolism and deep venous thrombosis and others. Surgical complication like Intra-abdominal complications like Gastrointestinal anastomotic leak, fistula, Stoma complications, Abdominal wall / surgical site, Need of reexploration, Radiological intervention like pigtail insertion.

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 adults who have undergone CRS-HIPEC surgeries in the study period both for primary and recurrence.

排除标准

  • Patients with incomplete dataset.

结局指标

主要结局

Incidence of Grade 3 & 4 Clavien Dindo Complications and as per Comprehensive

时间窗: Until hospital discharge

Complication Index (CCI) following HIPEC surgery

时间窗: Until hospital discharge

Medical complications

时间窗: Until hospital discharge

1) Respiratory complications

时间窗: Until hospital discharge

2) Cardiovascular complications

时间窗: Until hospital discharge

3) Renal and pelvicalyceal system complications

时间窗: Until hospital discharge

4) Central nervous system complications like delirium etc

时间窗: Until hospital discharge

5) Hepatobilliary and gastrointestinal complications

时间窗: Until hospital discharge

6) Hematological complications

时间窗: Until hospital discharge

7) Sepsis: cause by central line, foleys catheter etc

时间窗: Until hospital discharge

8) Venous thromboembolism: pulmonary embolism and deep venous thrombosis

时间窗: Until hospital discharge

9) others

时间窗: Until hospital discharge

Surgical complications

时间窗: Until hospital discharge

1) Intra-abdominal complications like Gastrointestinal anastomotic leak, fistula.

时间窗: Until hospital discharge

2) Stoma complications

时间窗: Until hospital discharge

3) Abdominal wall / surgical site complications

时间窗: Until hospital discharge

4) Need of reexploration

时间窗: Until hospital discharge

5) Radiological intervention like pigtail insertion

时间窗: Until hospital discharge

次要结局

  • 1) Need of Invasive mechanical ventilation more than 24 hours(2) Need of ICU admission more than 3 days)

研究者

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

Dr Atul Kulkarni

Tata Memorial Centre

研究点 (1)

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