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OpenTrials
Completed

NCT Number: NCT03566056

Early Recovery Outcomes After Standardized Fast-track Whipples Procedure

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Complications to Whipples procedure

Other

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

Primary outcomes

  1. Hypotension, defined as mean arterial bloodpressure <65 mmHg, measured by invasive arterial blood-pressure, the first morning after surgery at 06.00 (AM)

    Time frame: 6 am on the day after surgery

    Number of patients with the need for nor-adrenalin infusion to maintain mean arterial blood-pressure >65 mmHg, the first morning after surgery

Sponsors and collaborators

Lead sponsor

Eske Kvanner Aasvang

Other

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 21, 2018
Registry last updated
Sep 25, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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