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NCT06475261Recruiting

Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy

Tissue Oximetry's Measurement in Cytoreductive Surgery With Hyperthermic Intraperitoneal Chemotherapy: Prospective Observational Study With Device

Source: ClinicalTrials.gov · Last updated 7 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

Tissue oximetry obtained from peripheral muscle measures the state of tissue oxygenation of various organs and, as already widely described in the literature, can be used to measure the state of kidney's tissue oxygenation. However, there is no evidence in the existing scientific literature on the use of muscle tissue oximetry in patients undergoing cytoreductive surgery for ovarian cancer with hyperthermic intraperitoneal chemotherapy. The primary objective of our study is to evaluate whether there is a correlation between average intraoperative muscle tissue oximetry below 65% (a value which is considered critical in the literature for the resulting cellular damage) and postoperative renal damage in patients undergoing cytoreductive surgery with hyperthermic intraperitoneal chemotherapy for ovarian cancer.

Status (registry)
Recruiting
Study type
Observational
Enrollment
50 (estimated)
First submitted
20 Jun 2024
Start date
27 Jul 2024
Primary completion date
31 Aug 2025
Lead sponsor
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
NCT number
NCT06475261

What you commit to

  • Study type: Observational
  • Planned participants: 50
  • From 27 Jul 2024 to the primary completion date, 31 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Cytoreductive surgery without hyperthermic intraperitoneal chemotherapy

Age

  • Age \< 18 years

Other

  • ASA \> or = 3

Who the study is looking for

  • American Society Anesthesiologists (ASA) Classification 1-2
  • Cytoreductive surgery for ovarian cancer with laparoscopic or laparotomic technique with Hypertermic Intraperitoneal Chemotherapy.

Age in the registry: 18 years to 75 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Policlinico "A. Gemelli" IRCCS
Coordinator of this site? Confirm its status
RomeItalyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.