Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05913245 |
| Other study ID # |
1738-N-22 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
March 30, 2023 |
| Est. completion date |
June 30, 2024 |
Study information
| Verified date |
June 2023 |
| Source |
Fundación Pública Andaluza para la gestión de la Investigación en Sevilla |
| Contact |
Daniel López-Herrera Rodríguez, PhD |
| Phone |
0034-955012276 |
| Email |
dalohero[@]gmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
In recent years, the world of anesthesiology is questioning one of its great dogmas: Are so
many hours of strict fasting necessary in patients who are candidates for elective surgeries?
The main objective of our clinical trial will be demonstrate whether preoperative oral
loading with hydrocarbonate beverages reduces the time of return of intestinal function in
the postoperative period compared to water administration and strict fasting in patients
undergoing elective radical cystectomy.
Description:
Many anaesthesiology societies now recommend intake of clear fluids (water, tea or coffee
without milk, juices without pulp) up to two hours before induction of anaesthesia for most
patients undergoing elective surgery. This change the traditional practice of overnight
fasting, while reducing thirst in the hours before surgery and seems to attenuate the
response to the stress that results from a major operation, such as activation of endocrine
and inflammatory systems which leads to tissue catabolism and insulin resistance. Among all
the complications, one of the most frequent in patients undergoing mayor surgeries is
undoubtedly paralytic ileus. The Enhanced Recovery After Surgery (ERAS) guidelines emphasize
the importance of preventing this event. To prevent ileus, prokinetic agents such as
metoclopramide are used, which although it has not been shown to shorten the period until the
first flatulence or the first peristaltic movement, decrease nausea and vomiting. Chewing gum
is another measure that is carried out, since it stimulates peristalsis and this measure if
it had significant effects in time until first flatulence and in time until first peristaltic
movement. In recent years there has been a great change in the perioperative management of
patients who will undergo a radical cystectomy. The weight of traditional perioperative care
has been an important barrier to the implementation of Fast Track (FT) protocols, since it is
difficult to change a therapeutic strategy that has been carried out for decades. The
positive results obtained in colorectal surgery led to Fast Track being implemented in other
types of surgery similar to colorectal surgery such as radical cystectomy. Although there is
apparently widespread enthusiasm for the implementation of Fast Track protocols, evidence of
the use of this type of protocols in cystectomy is not robust, numerous studies claim that
there is a big difference between the application of FT and the application of traditional
measures in terms of length of hospital stay or complications. Because of this, more
large-volume randomized experimental studies of patients are needed. This randomized double
blind placebo-controlled trial of preoperative oral carbohydrate (CHO) treatment in patients
undergoing elective radical cystectomy will investigate whether this treatment reduced the
time of return of intestinal function. Secondary outcomes will be the incidence of infection
of surgical wounds, the incidence of postoperative complications, the length of hospital stay
and early postoperative fatigue in the three groups of patients undergoing this type of
surgery.
