| CTRI Number |
CTRI/2025/02/079852 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
22/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective study of retrospective data |
| Study Design |
Other |
|
Public Title of Study
|
A review of problems that happened after surgery in patients who had HIPEC (a surgical procedure that treats certain abdominal cancers) |
|
Scientific Title of Study
|
A retrospective analysis of postoperative complications in Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy surgery: [CHERRY (Complications of HipEc suRgeRY)] |
| Trial Acronym |
CHERRY |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 4590_Protocol_Version_1.0_dated_11.09.2024 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Atul Kulkarni |
| Designation |
Professor and Head, Division of Critical Care |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Second Floor,Main Building,Dr.E.Borges Road, Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869077526 |
| Fax |
|
| Email |
kaivalyaak@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Atul Kulkarni |
| Designation |
Professor and Head, Division of Critical Care |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Second Floor,Main Building,Dr.E.Borges Road, Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869077526 |
| Fax |
|
| Email |
kaivalyaak@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Atul Kulkarni |
| Designation |
Professor and Head, Division of Critical Care |
| Affiliation |
Tata Memorial Centre |
| Address |
Department of Anaesthesia, Critical Care and Pain, Second Floor,Main Building,Dr.E.Borges Road, Tata Memorial Hospital
Mumbai
MAHARASHTRA
400012
India |
| Phone |
9869077526 |
| Fax |
|
| Email |
kaivalyaak@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Dept of Anaesthesia, Critical care and Pain, OT complex, Second floor, Main Building, Tata Memorial Hospital, Parel, Mumbai 400012 India |
|
|
Primary Sponsor
|
| Name |
Tata Memorial Hospital |
| Address |
Tata Memorial Hospital, Parel, Mumbai 400012, Maharashtra, India |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Atul Kulkarni |
Tata Memorial Centre |
Department of Anesthesia Critical care and Pain, Major OT complex, Second floor, Main Building, Tata Memorial Centre Dr E Borges Road, Parel,Mumbai-400012
Mumbai
MAHARASHTRA |
9869077526
kaivalyaak@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| TMH_Institutional Ethics Committee I |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C76-C80||Malignant neoplasms of ill-defined, other secondary and unspecified sites, (2) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
NA |
| Comparator Agent |
Nil |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All adults who have undergone CRS-HIPEC surgeries in the study period both for primary and recurrence. |
|
| ExclusionCriteria |
| Details |
Patients with incomplete dataset |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of Grade 3 & 4 Clavien Dindo Complications and as per Comprehensive
Complication Index (CCI) following HIPEC surgery
Medical complications
1) Respiratory complications
2) Cardiovascular complications
3) Renal and pelvicalyceal system complications
4) Central nervous system complications like delirium etc
5) Hepatobilliary and gastrointestinal complications
6) Hematological complications
7) Sepsis: cause by central line, foleys catheter etc
8) Venous thromboembolism: pulmonary embolism and deep venous thrombosis
9) others
Surgical complications
1) Intra-abdominal complications like Gastrointestinal anastomotic leak, fistula.
2) Stoma complications
3) Abdominal wall / surgical site complications
4) Need of reexploration
5) Radiological intervention like pigtail insertion |
Until hospital discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1) Need of Invasive mechanical ventilation more than 24 hours
2) Need of ICU admission more than 3 days
3) Mortality at 30 days and 90 days
|
Until hospital discharge |
|
|
Target Sample Size
|
Total Sample Size="400"
Sample Size from India="400"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
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. |