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Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial (LAROSE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01556204
First Posted: March 16, 2012
Last Update Posted: February 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
The Cleveland Clinic
Results First Submitted: May 16, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition: Endometriosis
Interventions: Procedure: Robotic surgery
Procedure: Laparoscopic Surgery

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Robotic Surgery

da Vinci Surgical System

Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).

Laparoscopy

Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm ports.

Surgery for endometriosis: The technique for resection of superficial and deep endometriosis will be performed in a standard fashion. All superficial lesions suspicious for endometriosis (pigmented and non-pigmented) will be completely resected until non-diseased peritoneal margins are visualized around the defect; all deep lesions suspicious for endometriosis will be completely resected until non-diseased margins are visualized in the tissue surrounding the defect. Cystectomy(ies) will be performed for endometrioma(s). The fascia of any port greater or equal to 10mm will be reapproximated. Cystoscopy would only be performed when deemed appropriate by the surgeon (e.g., to assess for lower urinary tract injury in cases that require extensive ureterolysis).


Participant Flow:   Overall Study
    Robotic Surgery   Laparoscopy
STARTED   35   38 
COMPLETED   35   38 
NOT COMPLETED   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Robotic Robotic surgery
Laparoscopic Laparoscopic surgery
Total Total of all reporting groups

Baseline Measures
   Robotic   Laparoscopic   Total 
Overall Participants Analyzed 
[Units: Participants]
 35   38   73 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.3  (7.2)   34.5  (8.5)   34.5  (8.5) 
Gender 
[Units: Participants]
Count of Participants
     
Female      35 100.0%      38 100.0%      73 100.0% 
Male      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
     
United States   35   38   73 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Operative Time   [ Time Frame: 1st 24 hours ]

2.  Secondary:   Pain   [ Time Frame: Baseline, 6-weeks, 6-months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Tommaso Falcone, M.D.
Organization: Cleveland Clinic
phone: 216-444-1752
e-mail: falcont@ccf.org



Responsible Party: The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT01556204     History of Changes
Other Study ID Numbers: 12-173
First Submitted: March 13, 2012
First Posted: March 16, 2012
Results First Submitted: May 16, 2016
Results First Posted: August 4, 2016
Last Update Posted: February 14, 2017