| CTRI Number |
CTRI/2019/08/020496 [Registered on: 01/08/2019] Trial Registered Prospectively |
| Last Modified On: |
20/07/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Enhanced Recopvery After HIPEC for Peritoneal Carcinamatosis |
|
Scientific Title of Study
|
Enhanced recovery after surgery in cytoreductive surgery with hyperthermic intraperitoneal chemotherapy in peritoneal carcinomatosis- compliance, safety & efficacy – a pilot study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr naveeth Shukkur |
| Designation |
Senior resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of Surgical Oncology
Super Specialty Block, 3rd Floor
Pondicherry
PONDICHERRY
605008
India |
| Phone |
09551303371 |
| Fax |
|
| Email |
nave.muchi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prashanth Penumadu |
| Designation |
Assosciate Professor |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of Surgical Oncology
Super Specialty block, 3rd floor
Pondicherry
PONDICHERRY
605008
India |
| Phone |
9042092936 |
| Fax |
|
| Email |
drpenumadu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Naveeth Shukkur |
| Designation |
Senior resident |
| Affiliation |
JIPMER, Pondicherry |
| Address |
Department of Surgical Oncology
Super Speciality Block, Third Floor
Pondicherry
PONDICHERRY
605008
India |
| Phone |
09551303371 |
| Fax |
|
| Email |
nave.muchi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of surgical Oncology, JIPMER, Pondicherry |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
NA |
| Type of Sponsor |
Other [Other(Self)] |
|
|
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 |
| Naveeth Shukkur |
JIPMER |
Department of Surgical Oncology, Super Speciality Block, JIPMER, PUDUCHERRY-605006
Pondicherry
PONDICHERRY |
9551303371
nave.muchi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JIPMER Institutional erthics Committee (human studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: C00-D49||Neoplasms, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ERAS in HIPEC |
we follow the steps of ERAS in HIPEC patients
once per patient
preop, intraop & post op |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
. Patients with a peritoneal carcinomatosis undergoing cytoreductive surgery and hyperthermic intraperitoneal chemotherapy
ii. Peritoneal carcinomatosis Index (PCI) Score any iii. Age >18 years and <65 years
iv. European Cooperative Oncology Group (ECOG) Performance status 0-1
vi. No functional disturbance in bone marrow; WBC at least 3,000/mm3, Platelet count of atleast125,000/mm3.
vii. No functional disturbance in liver; Bilirubin less than 2.5 mg/dL, PT-INR < 1.5
viii. No function disturbance in kidney; Creatinine no greater than 1.5 times upper limit of normal.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the compliance of ERAS protocol in patients with peritoneal carcinomatosis undergoing CRS & HIPEC
2. To identify the correlation of the compliance pattern with morbidity & mortality
|
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the length of ICU stay, hospital stay & factors associated with morbidity. |
30 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/09/2019 |
| 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="2"
Months="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
CRS and HIPEC often involve complex surgical procedures in addition to intraperitoneal chemotherapy. These procedures are challenging & complex with multiple organ resection, prolonged operating time & complex hemodynamic changes during & after surgery. Enhanced recovery after surgery (ERAS) protocols are multimodal perioperative care pathways designed to achieve early recovery after surgical procedures by maintaining preoperative organ function and reducing the profound stress response following surgery. There are multiple studies which have proved the feasibility and improved outcomes of ERAS in gastrointestinal surgery & gynecological surgery but very few studies regarding ERAS in CRS & HIPEC. Present study will evaluate the safety & feasibility of ERAS protocol in CRS & HIPEC. It is expected that the ERAS protocol can hasten the recovery after CRS & HIPEC and decrease the in-hospital stay & morbidity |