A Partners Prospective Study Assessing the Perioperative Outcomes of Common Methods of Minimally Invasive Contained Tissue Extraction
Conditions: Hysterectomy
Sponsor: Brigham and Women's Hospital

PARTNERS HUMAN RESEARCH COMMITTEE 
PROTOCOL SUMMARY 
Partners Human Subjects Research Application Form  
 
Filename: Protocol Summary 
Version Date:  June 1, 2005 
 
  
1 
 
Answer all questions accurately and completely in order to provide the PHRC with the relevant 
information to assess the risk-benefit ratio for the study.  Do not leave sections blank. 
 
PRINCIPAL/OVERALL INVESTIGATOR 
Jon Ivar Einarsson, MD, PhD, MPH  
 
PROTOCOL TITLE 
 
A Partners prospective study assessing the perioperative outcomes of 
common methods of minimally invasive contained tissue extraction  
 
FUNDING 
None 
 
 
VERSION DATE 
1/13/2016 
 
 
SPECIFIC AIMS 
Concisely state the objectives of the study and the hypothesis being tested. 
 
The goal of this study is to compare common methods of tissue 
extraction at the time of minimally invasive surgery, including vaginal 
extraction and mini-laparotomy; both performed within a containment 
system.  The primary aim is to assess return to normal daily activities after 
each of the surgical techniques.  Return to daily activities will be recorded on 
a post-operative patient activity diary recording the following tasks: a) work 
(if applicable), b) domestic tasks, c) driving a vehicle (if applicable) and d) 
physical exercise (if applicable).  Additional information regarding post-
operative pain (measured on a Likert scale), potential complications of each 
technique, such as tearing of the bag or leakage, and peri- and post-operative 
outcomes will be collected. 
 
 
BACKGROUND AND SIGNIFICANCE 
Provide a brief paragraph summarizing prior experience important for understanding the 
proposed study and procedures. 
 
 
Laparoscopic approaches to gynecologic surgery are generally accepted 
as enabling superior visualization of the abdomino-pelvic cavity, smaller 
incisions, reduced blood loss and decreased recovery time relative to surgeries 
performed via laparotomy1, 2, 3. A common method of tissue extraction is 
laparoscopic power morcellation. Power morcellation systems have been 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
  2 
frequently employed in laparoscopic surgery, and effectively core the desired 
tissue into pieces that are small enough to be removed via the cannula in 
laparoscopic trocar ports. 
On 4/17/14 the FDA issued a statement discouraging the use of power 
morcellation. The FDA released further guidance on 11/24/14 that encourages 
alternatives to laparoscopic power morcellation for women with symptomatic 
uterine fibroids, such as vaginal or abdominal specimen removal and 
laparotomy using a smaller incision (mini-laparotomy). Given the recent 
limitations on use of power morcellation, manual morcellation via vagina or 
minilaparotomy with use of a knife blade are the only options which allow for 
large specimen removal at the time of minimally invasive surgery. This study 
will compare two methods of manual morcellation: vaginal extraction and 
mini-laparotomy 
incision. 
Although 
the 
techniques 
for 
vaginal 
or 
minilaparotomy morcellation have not typically involved use of a containment 
bag as standard of practice, we plan to perform all morcellation procedures 
within a containment bag system in an attempt to minimize any risks 
associated with tissue disruption or dissemination.  
 
 
RESEARCH DESIGN AND METHODS 
Briefly describe study design and anticipated enrollment, i.e., number of subjects to be enrolled 
by researchers study-wide and by Partners researchers.  Provide a brief summary of the 
eligibility criteria (for example, age range, gender, medical condition).  Include any local site 
restrictions, for example, “Enrollment at Partners will be limited to adults although the sponsor’s 
protocol is open to both children and adults.”
 
This study is designed as a prospective cohort study. The primary aim 
is to assess return to daily activities after the two methods of tissue extraction. 
Secondary aims include evaluating peri-operative outcomes and incidence of 
spillage of the morcellated tissue or fluids in the abdomen and pelvis.  
 
We anticipate enrolling a total of 70 adult women scheduled to undergo 
a laparoscopic Hysterectomy. Power calculation was based on a previous study 
which assessed recovery time in total laparoscopic hysterectomy and 
supracervical laparoscopic hysterectomy20. Using a study power of 90% and 
an alpha level of 0.05, we concluded that we would need 28 patients for each 
tissue extraction group (vaginal extraction and mini-laparotomy) in order to 
detect a mean difference of 5 days in return to daily activities, and an 
additional 14 patients to account for anticipated 25% loss to follow-up.  This 
will be a multi-center trial with surgeons participating at Brigham and 
Women’s Hospital, Faulkner Hospital and Massachusetts General Hospital. Our 
goal for enrollment is 70 subjects with the first 35 subjects included in a mid-
point analysis.  
Inclusion criteria include women 18 years of age or greater who are 
eligible to undergo laparoscopic Hysterectomy, as determined clinically by the 
operating surgeon. Other concomitant laparoscopic procedures will be 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
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performed as indicated and at the discretion of the primary surgeon (e.g., 
lysis of adhesions or removal of an ovarian cyst).  
In all cases, exclusion criteria will include suspected malignancy, 
medical illness precluding laparoscopy, inability to give informed consent, or 
allergy to indigo carmine or methylene blue dye.   
 
 
Briefly describe study procedures.  Include any local site restrictions, for example, “Subjects 
enrolled at Partners will not participate in the pharmacokinetic portion of the study.”  Describe 
study endpoints.
 
Subjects in this research study will undergo laparoscopic hysterectomy.  
Tissue extraction for hysterectomy patients will be performed via vaginal 
extraction with knife morcellation or mini-laparotomy incision with knife 
morcellation. All procedures will be performed within a containment system 
(bag).  The choice of procedure will be determined clinically by the operating 
surgeon based on patient characteristics and patient preference.   
 
Vaginal extraction with knife morcellation in bag 
 
Vaginal extraction with knife morcellation will be done in the standard 
fashion with the specimen being placed in a containment bag with the addition 
of 5cc of either indigo carmine or methylene blue dye.  
Vaginal extraction will be limited to total laparoscopic hysterectomy 
when a colpotomy (vaginal opening) is already made as part of the procedure. 
After the uterus is completely amputated from the vagina, a gloved sponge 
will be placed in the vagina to maintain pneumoperitoneum. A specimen 
retrieval bag of appropriate size will be introduced into the abdominal cavity 
via one of the abdominal ports or via the vaginal opening. The specimen will 
be placed in the bag and the opening of the bag brought out through the 
vaginal introitus, making sure that the whole circumference of the bag opening 
is exteriorized. With a syringe attached to an elongated aspirator tip, 5cc of 
either indigo carmine or methylene blue will be injected into the dependent 
portion of the bag with care to avoid spilling outside the bag. A self retaining 
Alexis-type retractor may be placed inside the bag to aid with retraction. It is 
recommended to maintain pneumoperitoneum within the abdomen during the 
morcellation process to aid with keeping viscera away from area of knife 
morcellation.  Knife morcellation will then proceed in the standard fashion until 
the specimen is removed. 
 
Mini-laparotomy incision with knife morcellation in bag 
 
Mini-laparotomy incision with knife morcellation will be done in the 
standard fashion with the specimen being placed in a containment bag with 
the addition of 5cc of either indigo carmine or methylene blue dye.  

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A 2-5 cm mini-laparotomy will be made either at suprapubic or umbilical 
location.  Upon abdominal entry, a self-retaining Alexis-type retractor or gel 
port single-port device is placed. The specimen retrieval bag is then placed 
intra-abdominally through the mini-laparotomy. A cap is placed over the 
retractor or port to maintain pneumoperitoneum. Switching back to 
laparoscopy, the specimen is then placed into the bag and the opening of the 
bag is brought out through the mini-laparotomy, making sure that the whole 
circumference of the bag opening is exteriorized. 5cc of either indigo carmine 
or methylene blue will be injected into the dependent portion of the bag with 
care to avoid spilling outside the bag. The retractor may be placed inside the 
bag 
to 
aid 
with 
self-retraction. 
It 
is 
recommended 
to 
maintain 
pneumoperitoneum within the abdomen during the morcellation process to aid 
with keeping viscera away from area of knife morcellation. Knife morcellation 
will then proceed in the standard fashion. 
 
 
In all cases, following morcellation and removal of the bag, the abdomen 
and pelvis will be carefully examined for any signs of spillage of fluid, tissue 
or blue dye as well as the integrity of the containment system by the surgeon. 
After surgery the bag will be carefully examined for any tears or damage. The 
used bag will be emptied, washed, dried, and filled with blue dye-tinted fluid 
(indigo carmine or methylene blue). The bag will be filled to the level where it 
was inside the patient during morcellation, as noted by marking pen during 
morcellation process (ie: any portion of bag exterior to patient during 
morcellation process will not be assessed). 
If there is leakage noted prior to morcellation, the specimen will be 
removed and a new containment system will be replaced.  If there is trauma 
to surrounding structures (bladder, bowel, blood vessels) during morcellation, 
the procedure will be discontinued.  Conversion to laparotomy may be 
performed to repair these structures.   
 
After Surgery 
 
After surgery, patients will complete a report of their recovery 
symptoms in a diary including a report of pain, medication use and activities. 
They will fill out this diary daily until their post-operative visit or the day they 
return to perform their activities (work, household chores, driving and 
exercise) without limitations (exactly the same way they used to do before 
surgery, as determined by a pre-operative baseline diary), an estimated 2-4 
week time frame.  
 
Post-operative Visit 
 
As per routine post-operative care, the patients will return for a post-
operative office visit between 2 and 6 weeks after surgery. This will include a 

Partners Human Subjects Research Application 
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Filename: Protocol Summary 
Version Date:  June 1, 
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discussion of recovery and exam as appropriate. Patients will return their diary 
at this time if they have returned to normal activities. 
 
Follow-up 
 
Patients who had not yet returned to all of their activities by the post-
operative visit will receive a package either in person or in the mail including 
a pre-paid envelope for them to return when they have resumed all 
activities.  A phone call reminder will be made 2 weeks after sending the 
package. 
All data will be analyzed using SPSS. A member of the team (such as a 
research assistant who has been trained in HIPPA procedures) will be in charge 
of abstracting data from the medical records and entering this information into 
a study database.   
The following data points will be collected via the intraoperative data 
collection sheet: surgeon, patient MRN, date of surgery, hospital (BWH, FH, 
MGH), procedure (total hysterectomy, supracervical hysterectomy), 
approach (laparoscopic, robotic), method of tissue extraction (vaginal, mini-
laparotomy), size and location of mini-laparotomy if applicable, indication 
(pain/endometriosis, abdominal bleeding, fibroids, prolapse, other), length 
of procedure (incision to close), time for morcellation (insertion of bag to 
removal of bag),  type of bag (EcoSac, LapSac, Lahey Bag, EndoCatch, 
Anchor tissue retrieval, Alexis Contained Extraction System), use of bag 
protector, use of indigo carmine or methylene blue, bag 
breaking/tearing/leaking and spillage of dye or tissue fragments.  
The following data points will be extracted from the medical record: 
race, age, gravidity, parity, BMI, prior abdominal surgery (LSC, Laparotomy, 
None), pathology, weight of specimen, chromopertubation, intraoperative 
complications and estimated blood loss, concomitant procedures, hand-
assisted, 
cystoscopy 
(for 
hysterectomy), 
and 
adnexal 
surgery 
(for 
hysterectomy).  Post-operative complications will be assessed 8 weeks after 
surgery and rated using the Clavien-Dindo scale. Outcome information 
including EBL >1000ml, bowel injury, bladder/ureter injury, transfusion, 
conversion to open, reoperation, readmission and length of stay will also be 
collected. 
 
 
For studies involving treatment or diagnosis, provide information about standard of care at 
Partners (e.g., BWH, MGH) and indicate how the study procedures differ from standard care.  
Provide information on available alternative treatments, procedures, or methods of diagnosis.
 
On 4/17/14 the FDA issued a statement discouraging the use of power 
morcellation. The FDA document includes language that acknowledges the 
fact that surgeons have offered morcellation in closed systems (i.e. a bag) 
and it does not recommend against this technique. The most recent FDA 

Partners Human Subjects Research Application 
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Filename: Protocol Summary 
Version Date:  June 1, 
2005  
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guidance released on 11/24/14 allows for uncontained power morcellation in 
women who are not peri- or post-menopausal.  
Our study protocol is more conservative than the current FDA 
recommendations with the addition of a containment bag to minimize spread 
of tissue when performing manual morcellation with a knife blade.   
Women who choose not to participate in this study will receive 
traditional care as determined appropriate by patient and physician 
discussion. 
 
 
Describe how risks to subjects are minimized, for example, by using procedures which are 
consistent with sound research design and which do not unnecessarily expose subjects to risk or 
by using procedures already being performed on the subject for diagnostic or treatment purposes.
 
The risks to subjects are minimized by use of a tissue containment 
system during morcellation. There have been no reported risks of 
dissemination of tissue morcellated in an enclosed containment system.   
Risk of trauma to surrounding structures is minimized in a containment 
system as the specimen and scalpel is away from vital structures.   
 
 
Describe explicitly the methods for ensuring the safety of subjects.  Provide objective criteria for 
removing a subject from the study, for example, objective criteria for worsening disease/lack of 
improvement and/or unacceptable adverse events.  The inclusion of objective drop criteria is 
especially important in studies designed with placebo control groups.
 
We have been performing in bag morcellation since early 2014, and 
the events of tissue and dye spillage have been minimal. Should an 
unforeseen adverse event arise that appears likely to be related in any way 
to the study, the principal investigator will review cases, consider halting 
study and report the event to the IRB. Potential adverse events include 
vascular or visceral injury associated with the morcellator device, spread of 
tissue and leakage of dye or tissue. 
 
 
FORESEEABLE RISKS AND DISCOMFORTS 
Provide a brief description of any foreseeable risks and discomforts to subjects.  Include those 
related to drugs/devices/procedures being studied and/or administered/performed solely for 
research purposes.  In addition, include psychosocial risks, and risks related to privacy and 
confidentiality.  When applicable, describe risks to a developing fetus or nursing infant.
 
The participants are undergoing a surgically indicated procedure and all 
surgeons are experienced at performing laparoscopic hysterectomies and 
laparoscopic myomectomies. Subjects will not undergo any additional 

Partners Human Subjects Research Application 
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Filename: Protocol Summary 
Version Date:  June 1, 
2005  
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treatment as part of this study other than scheduled surgery. The study 
procedures will not cause any additional discomforts. 
There is a theoretical risk for tissue dissemination if the bag tears or 
breaks. The use of a containment bag does not pose an additional threat to 
women undergoing vaginal extraction or mini-laparotomy incision, and 
represents an additional safety step over traditional practice in cases of 
vaginal or minilaparotomy morcellation.   
There have been no studies evaluating risk of indigo carmine dye 
spillage; however there have been reports of a pressor effect with use of 
indigo carmine.  Diluted indigo carmine dye has been used for 
chromopertubation (evaluation of the patency of fallopian tubes).  There 
have been no reported reactions during these procedures. There have also 
been no studies evaluating the risk of methylene blue dye spillage.  Diluted 
methylene blue has also been used routinely for chromopertubation.  There 
have been no reported reactions during these procedures.   Thus, if there is 
spillage of dye into the abdomen or pelvis, risk of a reaction is theoretically 
low.   
There is the possibility that the process of keeping a diary about pain 
and return to daily activities will cause subjects discomfort.   
There are no other foreseeable risks or discomforts to subjects. Should 
an unforeseen adverse event arise that appears likely to be related in any 
way to the study, the principal investigator will halt the study and report the 
event to the IRB. 
 
 
EXPECTED BENEFITS 
Describe both the expected benefits to individual subjects participating in the research and the 
importance of the knowledge that may reasonably be expected to result from the study.  Provide 
a brief, realistic summary of potential benefits to subjects, for example, “It is hoped that the 
treatment will result in a partial reduction in tumor size in at least 25% of the enrolled subjects.”  
Indicate how the results of the study will benefit future patients with the disease/condition being 
studied and/or society, e.g., through increased knowledge of human physiology or behavior, 
improved safety, or technological advances. 
 
Patients enrolled that undergo laparoscopic morcellation in a 
containment system (bag) may experience traditional benefits of minimally 
invasive surgery. These include, but are not limited to, lower incidence of 
complications, such as infection, hemorrhage, deep venous thrombosis and 
pulmonary embolism, incisional hernias, postoperative adhesions. We 
hypothesize that patients who have vaginal morcellation will experience earlier 
return to normal activities compared to mini-laparotomy.  The effect on 
operating room times is unknown. Moreover, the results of our study may 
provide the investigators with valuable information to facilitate the creation of 
an ideal morcellation containment system to be used in future gynecologic 
laparoscopies.  A greater understanding of alternatives to laparoscopic power 

Partners Human Subjects Research Application 
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morcellation (vaginal extraction and mini-laparotomy incision) will be gained 
and may benefit future patients.  
 
 
EQUITABLE SELECTION OF SUBJECTS 
The risks and benefits of the research must be fairly distributed among the populations that stand 
to benefit from it.  No group of persons, for example, men, women, pregnant women, children, 
and minorities, should be categorically excluded from the research without a good scientific or 
ethical reason to do so.  Please provide the basis for concluding that the study population is 
representative of the population that stands to potentially benefit from this research.
 
The study population of women will be derived from the population 
that is seeking laparoscopic Hysterectomy at Brigham and Women’s 
Hospital, Faulkner Hospital, and Massachusetts General Hospital. All cases of 
laparoscopic hysterectomies and myomectomies will be eligible. The first 35 
eligible cases will comprise the subset for mid-point analysis.  Patients with a 
known allergy to indigo carmine or methylene blue will be excluded from the 
recruitment.  
 
This is the same population that stands to potentially benefit from this 
research. 
 
 
 
 
 
 
 
 
When people who do not speak English are excluded from participation in the research, provide 
the scientific rationale for doing so.  Individuals who do not speak English should not be denied 
participation in research simply because it is inconvenient to translate the consent form in 
different languages and to have an interpreter present.
 
There are no plans to exclude non-English speaking subjects from this 
research project. When potential non-English speaking subjects are 
encountered, the hospitals’ translator services will be asked to assist with 
explaining the study and obtaining informed consent. The PHRC policy on 
Obtaining and Documenting Informed Consent of Subjects who do not speak 
English will be followed.   
 
 
For guidance, refer to the following Partners policy: 
          Obtaining and Documenting Informed Consent of Subjects who do not Speak English
          http://healthcare.partners.org/phsirb/nonengco.htm 
 
 
 
RECRUITMENT PROCEDURES 
Explain in detail the specific methodology that will be used to recruit subjects.  Specifically 
address how, when, where and by whom subjects will be identified and approached about 

Partners Human Subjects Research Application 
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Filename: Protocol Summary 
Version Date:  June 1, 
2005  
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participation.  Include any specific recruitment methods used to enhance recruitment of women 
and minorities.
 
Recruitment begins at the initial consult visit. The surgeon will explain 
the study, and then ask the patient if they would like to hear more about it. 
Only patients that affirm that they are interested will then be given a 
description of the study protocol by the surgeon and will be given a copy of 
the consent form to take home with them. A research assistant will contact 
the patient approximately one week after their initial appointment to confirm 
if the patient is interested in enrolling in the study and to answer any 
outstanding questions about the study. If the patient is interested in 
participating, informed consent will be obtained by a physician investigator 
prior to surgery.  
  
 
Provide details of remuneration, when applicable.  Even when subjects may derive medical 
benefit from participation, it is often the case that extra hospital visits, meals at the hospital, 
parking fees or other inconveniences will result in additional out-of-pocket expenses related to 
study participation.  Investigators may wish to consider providing reimbursement for such 
expenses when funding is available
 
There is no remuneration available for this study.  There are no 
additional hospital-related expenses anticipated as a result of patient 
participation in this study, as all visits described are within the standard 
guidelines for routine surgery.  
 
 
For guidance, refer to the following Partners policies: 
          Recruitment of Research Subjects 
          http://healthcare.partners.org/phsirb/recruit.htm
 
          Guidelines for Advertisements for Recruiting Subjects
          http://healthcare.partners.org/phsirb/advert.htm
 
          Remuneration for Research Subjects
          http://healthcare.partners.org/phsirb/remun.htm
 
 
CONSENT PROCEDURES 
Explain in detail how, when, where, and by whom consent is obtained, and the timing of consent 
(i.e., how long subjects will be given to consider participation).  For most studies involving more 
than minimal risk and all studies involving investigational drugs/devices, a licensed physician 
investigator must obtain informed consent.  When subjects are to be enrolled from among the 
investigators’ own patients, describe how the potential for coercion will be avoided.
 

Partners Human Subjects Research Application 
Form 
 
Filename: Protocol Summary 
Version Date:  June 1, 
2005  
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Once a patient agrees to take part in this study, she will be screened, 
and if she is eligible, and agrees to participate in the study, the informed 
consent will be obtained by a physician investigator. The patient will keep a 
copy of the consent form and the signed original copy will be held on file.   
 
 
NOTE: When subjects are unable to give consent due to age (minors) or impaired decision-
making capacity, complete the forms for Research Involving Children as Subjects of Research 
and/or Research Involving Individuals with Impaired Decision-making Capacity, available on 
the New Submissions page on the PHRC website: 
http://healthcare.partners.org/phsirb/newapp.htm#Newapp
 
For guidance, refer to the following Partners policy: 
          Informed Consent of Research Subjects
          http://healthcare.partners.org/phsirb/infcons.htm
 
 
 
DATA AND SAFETY MONITORING 
Describe the plan for monitoring the data to ensure the safety of subjects.  The plan should 
include a brief description of (1) the safety and/or efficacy data that will be reviewed; (2) the 
planned frequency of review; and (3) who will be responsible for this review and for determining 
whether the research should be altered or stopped.  Include a brief description of any stopping 
rules for the study, when appropriate.  Depending upon the risk, size and complexity of the 
study, the investigator, an expert group, an independent Data and Safety Monitoring Board 
(DSMB) or others might be assigned primary responsibility for this monitoring activity.        
 
NOTE: Regardless of data and safety monitoring plans by the sponsor or others, the principal 
investigator is ultimately responsible for protecting the rights, safety, and welfare of subjects 
under his/her care. 
 
The principal investigator will review and investigate any study-related 
complications as they occur. An analysis of the data will be performed as 
necessary pursuant to any complications observed, and at the mid-point of 
the study. The primary investigator will be in charge of deciding if the study 
should be stopped based on these analyses.  There will be continuous 
monitoring of events by the principal investigator and prompt reporting of 
complications to the IRB and all other study physicians, in accordance with 
the study’s Data and Safety Monitoring Plan (DSMP). The principle investigator 
will also keep track of investigator deviations in terms of informed consent 
processes and study procedure, and all repeat deviations will be reviewed.  
Any unanticipated problems involving risks to subjects or others 
including adverse events will be reported to the Partners Human Research 
Committee (PHRC) in accordance with PHRC unanticipated problems reporting 
guidelines. Adverse events will be reported according to pre-established 
guidelines such that the relationship of the risks and benefits to subjects 

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participating in research studies remains acceptable throughout the conduct 
of the study.  Reports of unanticipated problems involving risks to subjects or 
others will be tracked on an adverse event tracking log and submitted through 
Insight/eIRB within 5 working days/7 calendar days of the date the 
investigator first becomes aware of the problem.  Adverse events and minor 
deviations tracking logs will also be maintained in-house.   
 
 
Describe the plan to be followed by the Principal Investigator/study staff for review of adverse 
events experienced by subjects under his/her care, and when applicable, for review of sponsor 
safety reports and DSMB reports.  Describe the plan for reporting adverse events to the sponsor 
and the Partners’ IRB and, when applicable, for submitting sponsor safety reports and DSMB 
reports to the Partners’ IRBs.  When the investigator is also the sponsor of the IND/IDE, include 
the plan for reporting of adverse events to the FDA and, when applicable, to investigators at 
other sites.   
 
NOTE: In addition to the adverse event reporting requirements of the sponsor, the principal 
investigator must follow the Partners Human Research Committee guidelines for Adverse Event 
Reporting
 
There are no foreseeable risks or discomforts to subjects. Should an 
unforeseen adverse event arise that appears likely to be related in any way to 
the study, the principal investigator will halt the study and report the event to 
the IRB. 
 
MONITORING AND QUALITY ASSURANCE 
Describe the plan to be followed by the principal investigator/study staff to monitor and assure 
the validity and integrity of the data and adherence to the IRB-approved protocol.  Specify who 
will be responsible for monitoring, and the planned frequency of monitoring.  For example, 
specify who will review the accuracy and completeness of case report form entries, source 
documents, and informed consent.   
 
NOTE: Regardless of monitoring plans by the sponsor or others, the principal investigator is 
ultimately responsible for ensuring that the study is conducted at his/her investigative site in 
accordance with the IRB-approved protocol, and applicable regulations and requirements of the 
IRB.
 
The principal investigator will perform continuous monitoring of any 
events and report problems to the IRB and other appropriate bodies as 
needed. 
All surgeons involved in this study will be responsible for completing 
correct operative data collection at the time of surgery, as well as during the 
post-operative period. A minimum number of persons will be involved with the 
data abstraction in an attempt to decrease introduction of bias. The research 
assistants will also keep a copy of all source documents such as informed 

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consent on file, and informed consent must be revisited in discussion with the 
patient on the day of surgery prior to subjecting her to study protocol. 
 
For guidance, refer to the following Partners policies: 
          Data and Safety Monitoring Plans and Quality Assurance
          http://healthcare.partners.org/phsirb/datasafe.htm
 
          Adverse Event Reporting Guidelines
          http://healthcare.partners.org/phsirb/adverse_events.htm
 
 
 
PRIVACY AND CONFIDENTIALITY 
Describe methods used to protect the privacy of subjects and maintain confidentiality of data 
collected.  This typically includes such practices as substituting codes for names and/or medical 
record numbers; removing face sheets or other identifiers from completed 
surveys/questionnaires; proper disposal of printed computer data; limited access to study data; 
use of password-protected computer databases; training for research staff on the importance of 
confidentiality of data, and storing research records in a secure location.   
 
NOTE: Additional measures, such as obtaining a Certificate of Confidentiality, should be 
considered and are strongly encouraged when the research involves the collection of sensitive 
data, such as sexual, criminal or illegal behaviors.
 
With regard to risk of disclosure of confidential patient information, all 
possible precautions will be taken to ensure the confidentiality of study data.  
Specific precautions include keeping all identifying information in password 
protected computer systems or in locked filing systems accessible only to 
study staff.   
 
SENDING SPECIMENS/DATA TO RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
Specimens or data collected by Partners investigators will be sent to research collaborators 
outside Partners, indicate to whom specimens/data will be sent, what information will be sent, 
and whether the specimens/data will contain identifiers that could be used by the outside 
collaborators to link the specimens/data to individual subjects.
 
No specimens or data will be sent outside of Partners. 
 
 
Specifically address whether specimens/data will be stored at collaborating sites outside 
Partners for future use not described in the protocol.  Include whether subjects can withdraw 
their specimens/data, and how they would do so.  When appropriate, submit documentation of 
IRB approval from the recipient institution.
 

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No specimens or data will be stored outside of Partners. 
 
 
RECEIVING SPECIMENS/DATA FROM RESEARCH COLLABORATORS OUTSIDE 
PARTNERS 
When specimens or data collected by research collaborators outside Partners will be sent to 
Partners investigators, indicate from where the specimens/data will be obtained and whether the 
specimens/data will contain identifiers that could be used by Partners investigators to link the 
specimens/data to individual subjects.  When appropriate, submit documentation of IRB 
approval and a copy of the IRB-approved consent form from the institution where the 
specimens/data were collected.
 
No specimens or data will be received from parties outside of Partners. 
 
 

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Filename: Protocol Summary 
Version Date:  June 1, 
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Official Title: A Partners prospective study assessing the perioperative 
outcomes of common methods of minimally invasive contained tissue 
extraction  
 
NCT Number: NCT02496130 
 
Date of Document: 1/13/2016