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

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.

Inclusion Criteria:

- women 18 years of age or greater who are to undergo laparoscopic treatment of
presumed endometriosis, as determined clinically by the operating surgeon.

Exclusion Criteria:

- suspected malignancy,

- medical illness precluding laparoscopy,

- inability to give informed consent,

- morbid obesity (BMI > 44), or

- need for concomitant bowel resection and/or ureteral reanastomosis.