U-shape incision on on prostate capsule: New intrapritineal laparoscopic technique in simple prostatectomy
Design
A clinical trial with two groups of patients: parallel, therapeutic, blanced block randomization, single blind (patient). 10 patients referred to Sinai Hospital.
Settings and conduct
10 patients at Sina Hospital. blanced block randomization, single blind(patient). Patients are divided into two groups:
Group 1: intrapritineal laparoscopic technique and U-shape incision on prostate capsule.
Group 2: Extraperitoneal laparoscopic technique and direct incision on the prostate capsule.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Patients with indications for prostate surgery: including infection, bladder stones, refractory retention, non-response to medical treatment, and refractory hematuria, Consent to participate in the study. Exclusion criteria:Abnormal rectal examination,Active infection,Severe heart or lung disease.
Intervention groups
Intervention group 1:intrapritineal laparoscopic technique and U-shape incision on prostate capsule.
Intervention group 2:Extraperitoneal laparoscopic technique and direct incision on the prostate capsule.
Main outcome variables
Duration of surgery,
Average bleeding during surgery,
Average length of hospital stay.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190624043991N15
Registration date:2021-07-28, 1400/05/06
Registration timing:prospective
Last update:2021-07-28, 1400/05/06
Update count:0
Registration date
2021-07-28, 1400/05/06
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-30, 1400/06/08
Expected recruitment end date
2022-01-28, 1400/11/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
U-shape incision on on prostate capsule: New intrapritineal laparoscopic technique in simple prostatectomy.
Public title
intrapritineal laparoscopic technique
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with indications for prostate surgery
infection
bladder stones
refractory retention
non-response to medical treatment
refractory hematuria
Consent to participate in the study
Exclusion criteria:
Abnormal rectal examination
Active infection
Severe heart or lung disease
Age
From 18 years old to 70 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
10
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a single-blind randomized clinical trial.
For randomization, the blanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined. According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned. After the methodologist prepares the randomization sequence using the sealdenvelop online site, the generated sequence will be made available to a technician outside the research team. Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician. The patient is placed in (intrapritineal laparoscopic technique and U-shape incision on prostate capsule) or (Extraperitoneal laparoscopic technique and direct incision on the prostate capsule) group based on the randomly selected envelope.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients who have given their consent to participate in the study will be treated with intrapritineal laparoscopic technique and U-shape incision on prostate capsule or Extraperitoneal laparoscopic technique and direct incision on the prostate capsule. The patient has no information about the surgical procedure and the design.
Placebo
Not used
Assignment
Parallel
Other design features
-
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sina Hospital Research Ethics Committee
Street address
Sina Hospital - Hassan Abad St. - Tehran - Iran
City
تهران
Province
Tehran
Postal code
1136746911
Approval date
2020-06-28, 1399/04/08
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1399.008
Health conditions studied
1
Description of health condition studied
Intraperitoneal laparoscopic prostatectomy
ICD-10 code
N42
ICD-10 code description
Other and unspecified disorders of prostate
Primary outcomes
1
Description
Improving surgical technique
Timepoint
before and one month after surgery
Method of measurement
International prostatectomy score, maximum urinary flow rate and Prostate-Specific Antigen
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: intrapritineal laparoscopic technique and U-shape incision on prostate capsule. During surgery; the patient is placed in the supine and intubated via a NG Tube. A Foley catheter 22f is inserted and the patient ‘s legs is placed at a 30-degree angle. Then a two-centimeter incision is made below the umbilicus, after that the peritoneum is opened and a 10 mm port is placed. The abdomen is then slowly filled with CO2 gas and two ports (5mm) are inserted in the umbilicus and the lateral of rectum under direct vision. In the next step, peritoneum is opened in the anterior part of the bladder and then the fourth port is placed in the suprapubic area for suctioning. The prostate capsule is opened transversely by a U-Shape incision at the distance of 0.5 cm from the bladder neck. At this time, the prostate adenoma is removed by suction and after inserting a 22f catheter, the capsule is sutured continuously. Patient is discharged with the catheter. One week later, the patient catheter is removed and 3 months later, IPSS and QMAX will measured again.
Category
Treatment - Surgery
2
Description
Intervention group: Extraperitoneal laparoscopic technique and direct incision on the prostate capsule
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Urology Research Center, Sina Hospital, Imam Khomeini St., Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center, Sina Hospital , Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center, Sina Hospital , Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Urology Research Center, Sina Hospital , Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
demographic information anonymously
When the data will become available and for how long
one year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Any analysis can be done with the consent of the main researcher
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.