Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial (LAROSE)
|First Submitted Date ICMJE||March 13, 2012|
|First Posted Date ICMJE||March 16, 2012|
|Results First Submitted Date||May 16, 2016|
|Results First Posted Date||August 4, 2016|
|Last Update Posted Date||February 14, 2017|
|Start Date ICMJE||March 2012|
|Primary Completion Date||December 2015 (Final data collection date for primary outcome measure)|
|Current Primary Outcome Measures ICMJE
||Operative Time [ Time Frame: 1st 24 hours ]
Operative time is defined as skin incision to skin closure.
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT01556204 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Pain [ Time Frame: Baseline, 6-weeks, 6-months ]
Pain as estimated by endometriosis, Endometriosis Health Profile-30 (EHP-30). Score ranges from 0-100. Lower score denotes improvement. Pain: As score decreases, pain decreases. No subscales.
|Original Secondary Outcome Measures ICMJE
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial|
|Official Title ICMJE||Laparoscopy vs. Robotic Surgery for Endometriosis (LAROSE): a Prospective Randomized Controlled Trial|
|Brief Summary||The objective of this study is to conduct a prospective randomized controlled trial of robotic-assisted versus conventional laparoscopy for the treatment of endometriosis.|
This is a prospective randomized control trial. Study subjects will be recruited from patients that present to the Department of Gynecology who are to have surgery for endometriosis at the Cleveland Clinic.
Patient that require bowel resection and/or ureteral reanastomosis are not included due to the fact that these events impact operating time significantly and are not commonly performed as part of endometriosis surgery (subjects may not be equally distributed among both arms).
Eligible patients that agree to participate will be provided written informed consent administered by the collaborators listed on this Institutional Review Board (IRB) at the above clinic locations. In addition to a standardized evaluation including the history and physical examination, the patients will complete the validated health-related quality of life questionnaires SF-12 and Endometriosis Health Profile-30 (EHP-30) with additional questions to determine baseline pain and activity scales as well as daily pain medication use.
Surgeries will be performed by two board certified gynecologic surgeons (TF and JG). JG will participate in the laparoscopic arm of the study (Beachwood Family Health and Surgery Center) while TF will participate in both arms (Cleveland Clinic main campus). The patients of JG randomized to robotic surgery will be performed by TF at Cleveland Clinic main campus.
Additionally, after the surgery, the patients will complete the above questionnaires as well as diaries addressing narcotic use and quality of life at 6 weeks and 6 months. Completion of questionnaires and diaries is the only additional assessment that is specific to participation in this study that is not usually included as part of the standard care for the treatment of endometriosis. It should take no more than 10 minutes to complete the questionnaires and less than 5 minutes each day to complete the diaries. The study subjects will not be exposed to any additional risk by participating in this study except for the inconvenience of completing the questionnaires and daily diaries.
The participants will be randomized preoperatively (at the time of surgery scheduling) according to a computer-generated randomization schedule with random block sizes with the use of the SAS statistical software package (SAS Institute, Cary, NC). All patients will be blinded to their assignment. Intraoperative randomization of the patients is not feasible due to the fact that the operating room staff and operating room assigned for a given case is different for robotic and traditional laparoscopic cases.
Patients who do not choose to participate in this study will still be offered the standard evaluation and management including laparoscopic treatment of endometriosis as deemed appropriate by the primary surgeon. Robotic-assisted laparoscopic treatment of endometriosis is not routinely performed in this institution however, and thus is not considered part of the standard of care.
Laparoscopic assisted resection of endometriosis will be performed using up to five 5mm. ports. An umbilical port will be placed for the laparoscope and additional ports as dictated by each individual surgery. The robotic-assisted resection of endometriosis will be performed using the da Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) using up to five ports as needed. An umbilical port will be placed for the laparoscope (10/12mm), a 5mm assistant port will be placed in the right lower quadrant and two or three 8 mm robotic ports will be placed in the lower quadrants bilaterally.
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 or will be fulgurized using bipolar energy; 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).
Patients that are found not to have endometriosis at the time of surgery will be excluded from the study. The robot will be docked for all cases assigned for this arm irrespective of the amount of disease encountered (including mild endometriosis).
Data points recorded during the procedure will include: operating room time of entry and exit and time from incision to closure. From this information, the operating room costs and anesthesia costs, i.e., the amount that a provider must pay for goods or services, will be calculated. Estimated blood loss, perioperative and post-operative complications, and number of days in the hospital (in cases that warrant admission) will be calculated. The standard American Society of Reproductive Medicine (ASRM) intraoperative endometriosis scoring system will be documented at the end of each surgery. Procedure and inpatient hospital costs (if applicable) will also be determined. All the operating room data (including the primary outcome) will be collected by a research nurse or coordinator that will be assigned for this task (to optimize reliability of these measurements).
Patients will complete their daily narcotic use, which will include oral as well as patient-controlled analgesia IV narcotic use in the hospital when applicable as well as quality of life diaries. Patients will return to clinic for a two week post-operative visit.
Prior to surgery, the patients will undergo a physical examination by a physician who is blinded to the patient's surgical group assignments. Additionally, patients will fill out the SF-12 health survey, EHP-30 and activity assessment questionnaires, pain scale and daily pain medication / narcotic use at baseline.
At the 2 week postoperative visit, a routine physical exam will be performed, the daily pain medication diary will be retrieved and the questionnaires for surgical pain and activity assessment will be applied.
At 6 weeks and 6 months, the nurse or physician will repeat the questionnaires by email (using Redcap), mailed questionnaires or over the telephone (SF-12, EHP-30, pain scales, daily pain medication / narcotic use and activity assessment questionnaires). The physician or nurse will also collect all the intraoperative and inpatient data for this project as well as review the medical record for possible admissions and postoperative complications.
All data points and demographic information will be recorded in a secured, password protected database on the Gynresearch drive that will only be assessed by the collaborators on this IRB. Subjects will only be identified by their Cleveland Clinic medical record number. It is necessary to identify patients in this manner so that their clinical progress (e.g. postoperative complications, emergency room visits) can be located and recorded on the database.
|Study Type ICMJE||Interventional|
|Study Phase||Not Provided|
|Study Design ICMJE||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||December 2015|
|Primary Completion Date||December 2015 (Final data collection date for primary outcome measure)|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT01556204|
|Other Study ID Numbers ICMJE||12-173|
|Has Data Monitoring Committee||No|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||
|Responsible Party||The Cleveland Clinic|
|Study Sponsor ICMJE||The Cleveland Clinic|
|Collaborators ICMJE||Not Provided|
|PRS Account||The Cleveland Clinic|
|Verification Date||December 2016|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP