This study aims to compare objective and subjective operational related outcomes between laparoscopic ovarian cystectomies with and without robotic assistance. Laparoscopic ovarian cyctectomy will be performed by entering laparoscope through three 5 mm incisions on the abdomen; then, cyst wall is removed and bleeding sites are controlled. This study is single blind randomized control trial. This trial begins from November 2010 and our time limit is up to June 2011 all patients recruited from Arash hospital. Eligible patients are those with small and moderate size cysts (3 to 10 cm), sonographically benign ovarian cysts and normal tumor markers. Patients with large size cysts, increased tumor markers and medical and surgical contraindications for laparoscopic surgery are excluded from the study. All operations will be done by trained surgeon in this field (at least 10 hour). Forty patients are equally divided into two groups. One group receives robotic assistance operation and the other human assistance. Time of operation and tiredness of the surgeon as primary outcomes and some secondary outcomes are all compared between two groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201104035867N3
Registration date:2011-05-18, 1390/02/28
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2011-05-18, 1390/02/28
Registrant information
Name
Haydeh Samiee
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1857
Email address
hsamiee@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences(TUMS) and Sharif University of Technology
Expected recruitment start date
2010-11-15, 1389/08/24
Expected recruitment end date
2011-06-05, 1390/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of surgeon assistant robot in laparoscopic ovarian cystectomy vs conventional laparoscopic ovarian cystectomy
Public title
Comparison of the efficacy of surgeon assistant robot in laparoscopic ovarian cystectomy vs conventional laparoscopic ovarian cystectomy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria:
Small or middle size(3-10cm); simple,thin wall and benign ovarian cyst(s); normal ovarian tumor markers; sonographic approval of benign cyst and trained surgeon for robotic laparoscopic surgery
Exclusion Criteria: Medical or surgical contraindication for laparoscopic surgery; elevated ovarian tumor marker(s); large size (more than 10cm)cyst and unaccepted robotic surgery by the patient
Age
From 14 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
6th floor,tehran university of medical sciences,Bulvar Str.
City
Tehran
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
۱۵۸۱/ ۱۳۰/ د/ ۸۹
Health conditions studied
1
Description of health condition studied
Ovarian cyst
ICD-10 code
N83.2
ICD-10 code description
Other and unspecified ovarian cysts
Primary outcomes
1
Description
Tiredness of the surgeon
Timepoint
At the end of operation
Method of measurement
Desirrment or undesirment to continue the procedure+ Feeling and expression of tiredness by the surgeon
2
Description
Lenght of the operation
Timepoint
For each operation
Method of measurement
Lenght of operation from the entering of lens to the abdomen to its removal time
Secondary outcomes
1
Description
Frequency of undesired movement of the lens and camera head cleaning
Timepoint
During the operation
Method of measurement
Frequency of occurrences
2
Description
Frequency of changing robot to human assist
Timepoint
During the operation
Method of measurement
Frequency of changing
3
Description
occupied space of the room
Timepoint
during the operation
Method of measurement
The proportion of the space occupied with system to the entire room space
4
Description
Frequency of lens focus correction
Timepoint
During operation
Method of measurement
Frequency of occurrences
5
Description
Responding to the surgeon's orders
Timepoint
During the operation
Method of measurement
Frequency of occurrences of proper responses and non responses