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CompletedNCT02325648Updated Nov 2, 2016

The Intraoperative Physiologic Changes of Patients Under Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Prospective Observational Study

An observational study in Peritoneal Surface Malignancies, sponsored by Yonsei University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-11-02.

Sponsored by Yonsei University · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
22
Ages
20 Years and older
Sex
All
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Study summary

The most popular surgical treatment of peritoneal cancer is the type known as hyperthermic intraperitoneal chemoperfusion (HIPEC), a type of cytoreductive surgery for which a significantly high survival rate has been demonstrated by several studies. It is widely known that HIPEC entails severe physiological changes and precautions during anesthesia. However, very few studies have systematically outlined and organized these changes for each system, and most existing studies only report retrospective data or are limited to gynecological surgeries. Therefore, the present researchers planned a prospective observational study to determine the physiological changes that occur in patients during HIPEC cytoreductive surgeries performed in the colon and rectal surgery department of the investigators hospital. The investigators planned to monitor the patients' body temperature, metabolism, cardiovascular and respiratory changes during HIPEC cytoreductive surgery and analyze the anesthetic methods applied to identify the optimal anesthetic management strategy for HIPEC cytoreductive surgeries.

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Conditions studied

  • Peritoneal Surface Malignancies

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03

In context

Peritoneal Neoplasms

361 studies on the registry are indexed under Peritoneal Neoplasms; 56 are open to participants now.

This study's enrollment of 22 is below the median of 100 across 53 observational studies indexed under Peritoneal Neoplasms.

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Lead sponsor

Yonsei University is the lead sponsor of 1,387 studies on the registry; 232 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

patients who undergoing HIPEC cytoreductive surgery

Inclusion criteria

  • Adult patients 20 years of age or older who will undergo HIPEC cytoreductive surgery at the colon and rectal surgery department of our hospital

Exclusion criteria

Exclusion Criteria:

  • Cases in which there is a sudden change of surgery plans, or those in which consent forms are retracted.
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
22 participants (actual)
Patient registry
No

Groups and cohorts

  • HIPEC cytoreductive surgery

    Drug: HIPEC cytoreductive surgery

Interventions

  • DrugHIPEC cytoreductive surgery

    At least 30 minutes prior to the prospective conclusion of the surgery, 1 μg/kg of fentanyl is administered for postoperative analgesia and 0.075mg of palonosetron is IV-infused for the prevention of nausea and vomiting. Desflurane and remifentanil administration is ceased after the surgery is concluded, muscle relaxation is evaluated by train of four (TOP) monitoring using a nerve stimulator, and the neuromuscular blockade is reversed with 0.2 mg of glycopyrrolate and 1 mg of neostigmine. When the patient recovers consciousness and begins spontaneous respiration, extubation is performed and the patient is transferred to the ICU with monitoring of their vital signs.

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What researchers measure

Primary outcomes

  1. Vital sign

    Time frame: from 30 minutes to 90 minutes after HIPEC

  2. Body temperature

    Time frame: from 30 minutes to 90 minutes after HIPEC

  3. serum glucose

    Time frame: from 30 minutes to 90 minutes after HIPEC

  4. pulmonary vascular permeability index

    Time frame: from 30 minutes to 90 minutes after HIPEC

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Study locations

1 site
  • Severance Hospital
    Seoul, South Korea 120-752, Korea, Republic of
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References and documents

Publications

  • Kim MH, Yoo YC, Bai SJ, Lee KY, Kim N, Lee KY. Physiologic and hemodynamic changes in patients undergoing open abdominal cytoreductive surgery with hyperthermic intraperitoneal chemotherapy. J Int Med Res. 2021 Jan;49(1):300060520983263. doi: 10.1177/0300060520983263. PubMed 33445991 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 2, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02325648
Lead sponsor
Yonsei University
Responsible party
Sponsor
First posted
Dec 25, 2014
Start date
Dec 2014
Primary completion
Apr 2016
Completion
Apr 2016
Last update
Nov 2, 2016

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2016. You cannot join it, but the record below documents what was studied.

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