Enhanced Recopvery After HIPEC for Peritoneal Carcinamatosis

Not yet recruiting

• Conditions: Neoplasms,

• Registration Number: CTRI/2019/08/020496

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-01-09
• Last Update Posted: 2019-07-20

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.
• 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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. To assess the compliance of ERAS protocol in patients with peritoneal carcinomatosis undergoing CRS & HIPEC	30 Days
2. To identify the correlation of the compliance pattern with morbidity & mortality	30 Days

Secondary Outcome Measures

Name	Time	Method
To assess the length of ICU stay, hospital stay & factors associated with morbidity.	30 days

Trial Locations

Locations (1)

JIPMER; 🇮🇳 Pondicherry, PONDICHERRY, India

JIPMER

🇮🇳Pondicherry, PONDICHERRY, India

Naveeth Shukkur

Principal investigator

9551303371

nave.muchi@gmail.com