Clinical trial · Observational
An Audit of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy
A Prospective Audit of Perioperative Parameters of Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy (CRS-HIPEC)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Peritoneal carcinomatosis is a common event in the natural history of colorectal and other digestive tract cancers. Cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) provides a promising therapeutic option for highly selected patients with peritoneal carcinomatosis arising from different malignancies such as colorectal cancer, gastric cancer, ovarian cancer, or peritoneal mesothelioma with improvement of both patient survival and quality of life. CRS, i.e., removal of all visible metastatic abdominal and pelvic disease with peritonectomy along with HIPEC (for 90 min at a temperature of 42º C) and/or early postoperative intraperitoneal chemotherapy (EPIC) in order to eradicate all microscopic metastasis. CRS with HIPEC is a long and complex procedure with significant blood and fluid loss during debulking, hemodynamic, hematological, and metabolic alterations before and during the HIPEC phase, and even in the early postoperative period, with resultant significant morbidity and mortality. Despite that most of the reported patients are in American Society of Anesthesiologist class I and II, without significant comorbidities or systemic disorder; the morbidity and mortality ranges from 12 to 65% in these procedures, so a well coordinated team of anesthesiologist, surgeons and intensivist and other ancillary services can result in good outcome. This study will see the challenges faced by the team regarding the pathophysiological alterations during the CRS with HIPEC in the perioperative period.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
| Peritoneal Disease | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Hyperthermic intraperitoneal chemotherapy | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (4)
- measure
- Changes in invasive blood pressure in perioperative period
- timeFrame
- From start of surgery upto 48 hours after surgery
- description
- Invasive blood pressure will be measured in radial artery in perioperative period and changes from baseline will be recorded in a graphical manner
- measure
- Changes in body temperature in perioperative period
- timeFrame
- From start of surgery upto 48 hours after surgery
- description
- Body temperature will be measured in degree centigrade by nasopharyngeal temperature probe in perioperative period and changes from baseline will be recorded in a graphical manner
- measure
- Changes in cardiac output in perioperative period
- timeFrame
- From start of surgery upto 48 hours after surgery
- description
- Cardiac output will be measured in perioperative period and changes from baseline will be recorded in a graphical manner
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age between 18 to 70 years 2. ASA Class I to III 3. Colorectal and gynecological oncology cases posted for CRS with HIPC. Exclusion Criteria: 1. Age less than 18 and more than 70 years 2. ASA Class IV and above
References
Publications (1)
- DERIVEDSolanki SL, Agarwal V, Ambulkar RP, Joshi MP, Chawathey S, Rudrappa SP, Bhandare M, Saklani AP. The Hemodynamic Management and Postoperative Outcomes After Cytoreductive Surgery and Hyperthermic Intraperitoneal Chemotherapy: A Prospective Observational Study. Crit Care Res Pract. 2024 Dec 27;2024:8815211. doi: 10.1155/ccrp/8815211. eCollection 2024. PMID 39760061