Early Recovery Outcomes After Standardized Fast-track Whipples Procedure

NCT03566056 | Completed

• 1 other identifier: RH-2016-304-potawhipple
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreas Cancer

Outcome Measures

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)

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

  6 am on the day after surgery

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patients included is chosen from all the patients in the surgery ward when they have undergone the Whipples procedure and furthermore meet the criteria listed above.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eske Kvanner Aasvang: lead

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principle investigator, Associate professor

Study Record Dates

• First Submitted: April 10, 2018
• First Posted: June 21, 2018
• Study Start: January 18, 2018
• Primary Completion: July 18, 2018
• Study Completion: July 18, 2018
• Last Updated: September 25, 2019

Record last verified: 2019-09

Locations

DK (1)