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Early Recovery Outcomes After Standardized Fast-track Whipples Procedure

Early Recovery Outcomes After Standardized Fast-track Whipples Procedure

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03566056
Enrollment
100
Registered
2018-06-21
Start date
2018-01-18
Completion date
2018-07-18
Last updated
2019-09-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pancreas Cancer

Brief summary

Today the Whipple procedure is the preferred operation for malignancy in the pancreas. In abdominal surgery this procedure is known for its high surgical stress-response in the patient, which has been attempted to be resolved with the introduction of preoperative high-dose steroids and goal-directed fluid therapy (GDT). Despite this effort, complications still occur regularly (30%) in the first weeks after the operation here at Rigshospitalet. Therefore there is still a challenge in the patients who have undergone the Whipple procedure in the acute postoperative phase. This shows in for example at Rigshospitalet, where 50% of the patients continue to be in the need of vasoactive medication the morning after the operation. Nevertheless, no studies have in detail described the acute (\<24h) postoperative phase. There is also an importance in the fact that there is often no description or control over other important factors, for example medicine with influence on the circulatory system, fluid treatment and response to this etc.. The purpose of this study is to investigate what issues or complications, in particular those of circulatory matter that occurs in this particular group of patients 24 hours after the operation. Furthermore there is lacking a description of which cause-response- link there can be between early and later (30 days) complications, as well as when each of these complications occur. Therefore, there will also be collected data on complications within the first 30 days after the operation for the purpose of a later secondary publication with the same authors.

Interventions

OTHERComplications to Whipples procedure

Patients undergoing the Whipple procedure often tend to have a lot of complications. This study aims to investigate what complications these patients experience

Sponsors

Eske Kvanner Aasvang
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* the patient has undergone the Whipple procedure * The patient is over 18 years ol * The patient has signed a consent statement from the postoperative therapy ward

Exclusion criteria

* The patient did not receive 125 mg of methylprednisolone prior to the operation * The patient did only undergo pancreatectomy * The patient wasn't given epidural anesthesia * the patient was given anesthesia through a mask

Design outcomes

Primary

MeasureTime frameDescription
Hypotension, defined as mean arterial bloodpressure <65 mmHg, measured by invasive arterial blood-pressure, the first morning after surgery at 06.00 (AM)6 am on the day after surgeryNumber of patients with the need for nor-adrenalin infusion to maintain mean arterial blood-pressure \>65 mmHg, the first morning after surgery

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026