Peritoneal Surface MalignanciesNCT02325648
The Intraoperative Physiologic Changes of Patients Under Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Prospective Observational Study
An observational study of Peritoneal Surface Malignancies, run by Yonsei University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peritoneal Surface Malignancies
- What is being tested?
- HIPEC cytoreductive surgery
- Type of treatment
- Injection or infusion
- How many people
- 22 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients who undergoing HIPEC cytoreductive surgery
Who may be able to join
- Adult patients 20 years of age or older who will undergo HIPEC cytoreductive surgery at the colon and rectal surgery department of our hospital
Who cannot join
- Cases in which there is a sudden change of surgery plans, or those in which consent forms are retracted.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Peritoneal Surface Malignancies
- Being tested
- HIPEC cytoreductive surgery
- Medical subject headings
- Peritoneal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HIPEC cytoreductive surgeryDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| HIPEC cytoreductive surgery | Not described Receives: Drug: HIPEC cytoreductive surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital sign
Measured: from 30 minutes to 90 minutes after HIPEC
Body temperature
Measured: from 30 minutes to 90 minutes after HIPEC
serum glucose
Measured: from 30 minutes to 90 minutes after HIPEC
pulmonary vascular permeability index
Measured: from 30 minutes to 90 minutes after HIPEC
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peritoneal Surface MalignanciesStudies of the same condition, open and under way.
- More trials run by Yonsei UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02325648
- Sponsor's protocol ID
- 4-2014-0854
- Status last verified
- Nov 2016
- First submitted
- 14 Dec 2014
- Last updated
- 2 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intraoperative Physiologic Changes of Patients Under Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Cytoreductive Surgery; Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02325648
- Acronym / sponsor ID
- 4-2014-0854
- Conditions
- Peritoneal Surface Malignancies
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 25 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HIPEC cytoreductive surgery | – | Drug: HIPEC cytoreductive surgery |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients who undergoing HIPEC cytoreductive surgery
Key inclusion criteria (1 listed)
- Adult patients 20 years of age or older who will undergo HIPEC cytoreductive surgery at the colon and rectal surgery department of our hospital
Key exclusion criteria (1 listed)
- Cases in which there is a sudden change of surgery plans, or those in which consent forms are retracted.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HIPEC cytoreductive surgeryAt 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. | Drug | HIPEC cytoreductive surgery |
Primary outcome
Vital sign
Time frame: from 30 minutes to 90 minutes after HIPEC
Body temperature
Time frame: from 30 minutes to 90 minutes after HIPEC
serum glucose
Time frame: from 30 minutes to 90 minutes after HIPEC
pulmonary vascular permeability index
Time frame: from 30 minutes to 90 minutes after HIPEC
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2016.
- Derived from this study: PubMed 33445991Kim 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peritoneal Surface Malignancies, run by Yonsei University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital sign (time frame: from 30 minutes to 90 minutes after HIPEC). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02325648, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2016.