Pheochromocytoma Clinical Trial
Official title:
Posterior Retroperitoneoscopic Approach Versus Transperitoneal Laparoscopic Approach in Management of Adrenal Tumors: A Randomized Comparative Study
This randomized comparative study assesses the safety and efficacy of the posterior retroperitoneoscopic adrenalectomy in comparison to the standard, anterior transperitoneal approach and suppose that this new technique is a safe and effective alternative to the standard approach.
Aim of the study:
To upgrade the urosurgical care level for candidate of surgical adrenalectomy due to adrenal
diseases, to increase efficacy of the procedure and shorten the operative time and duration
of hospital stay and convalescence.
Study Objective:
Comparing the safety and efficacy of posterior retroperitoneoscopic versus anterior
transperitoneal adrenalectomy, as regard to the operative time, estimated intraoperative
blood loss, days of postoperative hospital stay, and rate of complications.
Study Question:
Can the posterior retroperitoneoscopic approach provide a better alternative to anterior
laparoscopic approach in terms of effectiveness and safety for laparoscopic adrenalectomy?
Study Hypothesis:
Investigators suggest that posterior retroperitoneoscopic approach is a safe and effective
alternative to anterior transperitoneal approach for adrenalectomy with less operative time,
estimated blood loss, postoperative days of hospitalization and rate of complications.
Significance and Relevance:
This study is suspected to be beneficial for urologists and oncology surgeons, as they can
select the most effective intervention for patients with adrenal disease.
Study setting:
The study will be carried out over one year starting from 4/2015 to 5/2016, including the
operations and data management. Operative procedures will be carried out at Urology
Departments on Suez Canal, and Alexandria University hospitals.
Study population The study will focus on patients with adrenal disease indicated for
adrenalectomy. The sample frame will include patients of any age, gender and body weight,
with fair cognitive function, who is candidate for simple laparoscopic adrenalectomy in Suez
Canal University Hospital and Alexandria University Hospital. Inclusion and exclusion
criteria will be mentioned at Eligibility section.
Sampling:
A non-probability convenience sample will be taken. That is the cases present and referred
to urology clinic and diagnosed to have adrenal mass or hyperplasia and are candidates for
laparoscopic adrenalectomy.
The sample size will be calculated to compare mean values of two independent groups of equal
sizes with a possibility of two way outcome. The sample size will be 20 cases, randomly
divided into 10 cases for each group.
Work plan:
The main objective of the study is to compare the data related obtained in the two
laparoscopic approachs in order to assess the efficacy of each one and determine a statistic
evidence of preferring one of them over the other. This goal could be achieved through the
following steps. First, patient evaluation; and this will be through the urology clinic of
the university hospitals in Suez Canal and Alexandria Universities. It also includes
patients referred from related clinics of oncosurgery, gynecology, endocrinology and
cardiology clinics. History taking, full clinical examination will be done. Laboratory
investigations will be requested according to provisional clinical diagnosis. Imaging
studies will be done to confirm final diagnosis and determine the treatment plan. Second, as
the case is indicated and fit for laparoscopic adrenalectomy, and as the case fulfill the
inclusion criteria of the study, the patient will get a study number and will be randomly
assigned to each operative approach. Third phase of the study is postoperative follow up.
The patient will be followed for a month. Parameters will include the postoperative days to
full diet, days to mobilization, days to discharge and days to full recovery. Also the
postoperative pain score and the scar cosmetic outcome are included.
Instruments:
The theatre room should be prepared for laparoscopic procedure with: a charge-coupled device
video camera, a video monitor, Xenon light source, high frequency generator and suction and
irrigation devices. Laparoscopic surgeries depend on five main steps. Insufflation using CO2
high flow insufflator. This step involve 2 techniques; the closed techniques with Veress
needle in transperitoneal access; and the open Hasson techniques. Trocar insertion that
include the multiport type, open or closed technique, retroperitoneal and transperitoneal.
Dissection through abdominal planes will need endoscopic curved scissors with or without
rotatable blades, endoscopic curved dissectors and suction irrigation probe. Also the
procedure may include sharp dissection with endoshears or blunt dissection with
endo-peanuts, right angle dissector. Upon heamostasis the basic instruments are: 5 mm
monopolar coagulation forceps/dissector, 5 mm bipolar forceps, 10 mm endoclip applicator and
endoscopic staplers. LigaSure™ for blunt dissection and heamostasis. Endoscopic needle
holder and short threaded small needle are needed for suturing. Finally, the LapSac™ is the
best tested bag for retrieval of specimens. The data of the patient and his preoperative and
postoperative parameters will be collected by a questionnaire designed for the purposes of
this study. It also include the traditional numerical rating scale and visual analogue scale
for assessment of the postoperative pain. The patient satisfaction of the scar will be
assessed by three questionnaires; body image questionnaire, photo series questionnaire and
future surgical procedure preference questionnaire.
Variables:
For each case the data will include demographic data of the patient and his medical and
surgical history. This includes age, gender, body mass index calculated as kg/square meter.
The side of the affected gland plays a role in operative time, so determination of the side
by computed tomography (CT) is essential. Also size of the adrenal mass in CT and the
clinical diagnosis regarding the function and the possibility of malignancy will also be
considered the main independent variable. A significant independent variable is the
surgeon's experience. The number and type of the procedures done by the operator with rate
and cause of conversions will be included to each case. Dependent variables will include the
full operative data of each case. Starting from the indication of the intervention and the
rationale for preference of laparoscopic approach and eventually the cause of conversion if
needed. This study focuses on operative time in minutes; total time from the first abdominal
incision to the last suture, and the time elapsed to identify the adrenal vein, a critical
step at the operation. The study is also interested in comparing the estimated blood loss
measured in milliliters and the correlation to the type of tumor, patients and operative
variables. On the postoperative phase, the data gathered include the number of days to full
diet, of post-operative hospital stay and to complete recovery; i.e. return to usual daily
activity. The patient will achieve a score assessment of the postoperative pain and
assessment of cosmotic outcome of the incisions. The rate of short term complications
postoperatively will be assessed for each group and classified by Clavien-Dindo system.
Statistical Analysis:
This will include data management and coding. The data entry will be via SPSS™ or Microsoft™
Excel™. Mainly the comparison of the study variables will be via detecting the significance
of differences between mean values of each group parameters. Finally, the data will be
arranged into tables and graphs and presented to conclude the findings of the study.
Ethical consideration:
All patients are informed about participation in training course for urology trainees as a
part of the consent of admission and getting surgical intervention at an authorized teaching
hospital. However, each participant will be offered an informed consent for being included
into this comparative study. The patient will receive his ideal and best line of treatment
according to the latest guidelines and available facilities whatever his response to the
consent. The risk of complications of both intervention is comparable and all participants
will have the same chance to have either transperitoneal or posterior retroperitoneal
approaches. To avoid bias, patient will be assigned randomly into the two study groups. At
the other hand, patient's data involved at this study will be treated confidentially.
Budget:
This study is funded by the researcher's financial resources. That includes transportation
fees, paper work and audio-video utilities. Cases done in the Suez Canal University Hospital
may be afforded by the college or the hospital fund. This includes the admission, the rent
of the laparoscopic set and the associated medications.
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