A Prospective Randomized Trial Comparing Restorelle Y Mesh vs. Restorelle Dual Flat Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy
Phase: NA
Conditions: Prolapse
Sponsor: The Cleveland Clinic

 
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A prospective randomized trial comparing restorelle Y mesh vs. restorelle dual flat 
mesh for laparoscopic and robotic-assisted laparoscopic sacrocolpopexy  
 
Cecile A. Unger, MD MPH; Fellow in Female Pelvic Medicine and Reconstructive 
Surgery. Center of Urogynecology and Pelvic Floor Disorders; Obstetrics/Gynecology 
and Women’s Health Institute at the Cleveland Clinic 
 
Beri M. Ridgeway, MD; Assistant Professor, Center of Urogynecology and Pelvic Floor 
Disorders; Obstetrics/Gynecology and Women’s Health Institute at the Cleveland Clinic 
 
Megan E. Tarr, MD; Assistant Professor, Center of Urogynecology and Pelvic Floor 
Disorders; Obstetrics/Gynecology and Women’s Health Institute at the Cleveland Clinic 
 
Marie Fidela R. Paraiso, MD; Professor, Section Head of the Center of Urogynecology 
and Pelvic Floor Disorders; Obstetrics/Gynecology and Women’s Health Institute at the 
Cleveland Clinic 
 
 
Background and Significance: 
 
Abdominal sacrocolpopexy is considered the gold standard for vault prolapse, and has 
demonstrated superior anatomic outcomes compared to transvaginal suspension 
procedures. Laparoscopic sacrocolpopexy has become an alternative to open abdominal 
sacrocolpopexy as this mode of surgery bridges the gap between the advantages of 
vaginal surgery, namely decreased morbidity and faster patient recovery, with the 
surgical success rates of abdominal sacrocolpopexy (1). For young women who are 
sexually active with symptomatic pelvic organ prolapse, reconstruction with a 
sacrocolpopexy procedure is beneficial because the success rates are high as the 
procedure adequately restores support of the vaginal apex and maintains vaginal length 
(2). Robotic-assisted laparoscopic sacrocolpopexy has also emerged as a mode of vaginal 
vault prolapse surgery, and is a good option for patients with significant body mass index, 
or known pelvic adhesive disease that may make a conventional laparoscopic approach 
more challenging.  
 
Sacrocolpopexy involves suspension of the vagina to the anterior longitudinal ligament of 
the sacrum at the level of S1 using a bridging graft which can be made of biologic or 
synthetic materials. The graft is sutured to the anterior as well as the posterior vagina and 
then attached to the anterior longitudinal ligament of the sacrum. There are a number of 
prosthetic materials available for use in pelvic reconstructive surgery, including 
sacrocolpopexy.  Mersilene was a popular prosthetic for many decades, but its use rapidly 
declined in favor of polypropylene which is now the most commonly used synthetic 
product (3). The ideal prosthetic material is biocompatible, inert, has minimal allergic or 
inflammatory reaction, is sterile, non-carcinogenic, resistant to infection, and avoids 
shrinkage and mechanical stress and is easy to handle and readily available at a 
reasonable cost (4). Additionally, pore size of the graft material affects resistance to 
infection and cellular infiltration and also the flexibility of the mesh (5). Lastly, the 
interaction at the tissue interface of the graft material is also very important, with the 

 
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ideal prosthesis causing minimal initial inflammatory and cellular response followed by 
adequate vascular and fibroblastic infiltration (6). Many different materials have been 
used as a graft in sacrocolpopexy including biologic materials (fascia lata, rectus fascia, 
dura mater) and synthetic materials (polypropylene mesh, polyester fiber mesh, 
polytetrafluorethylene mesh, Dacron mesh, and Silastic silicone rubber).  Large pore 
light-weight polypropylene mesh is a monofilament graft and is most commonly used 
today as it meets the above-mentioned requirements, and likely has fewer complications 
compared to other synthetics because of these characteristics (2).  
 
Restorelle Smartmesh (Coloplast®, Minneapolis, MN, USA) is an ultra-light 
macroporous polypropylene mesh graft intended for pelvic floor reconstruction. Two 
grafts are currently made for sacrocolposuspension: the restorelle Y mesh and the 
restorelle flat mesh (L mesh). The Y mesh has two arms which attach to the anterior and 
posterior vagina and a stem which attaches to the sacral promontory. The flat mesh is a 
sheet of polypropylene that comes in three sizes (Restorelle M Flat Mesh - 15cm x 10cm, 
Restorelle L Rectangle Flat Mesh - 24cm x 8cm, Restorelle XL Flat Mesh - 30cm x 
30cm) and can be trimmed into two strips that are attached to the anterior and posterior 
vagina, respectively, and then sutured together to the sacral promontory. Currently, both 
types of grafts are used to perform sacrocolpopexy.  
 
Cost of health care has become a hot topic in the medical community. One of the focuses 
of cost containment in medicine has centered around operating room efficiency. Several 
studies have looked at OR time nonutilization (7) in order to determine the economic 
value of saving OR time. Surgeons can make significant contributions to these types of 
savings by reducing equipment needs, facilitating case set-up times, and focusing on 
intraoperative efficiency. This includes choosing materials that may make certain 
procedures faster and more efficient. When performing a sacrocolpopexy, surgeons have 
the option of choosing a mesh graft configured in a Y shape, which requires introduction 
into the pelvis only once, and suturing of one arm to the sacral promontory; versus a dual 
flat mesh, which requires introduction into the pelvis twice, as there are two separate 
pieces to suture to the vagina, and suturing of both pieces of mesh together to the 
promontory. It is unclear if one version of the restorelle mesh is faster to use than the 
other, and if this savings in time, translates to cost savings in the operating room. The 
primary objective of the proposed study is to determine the difference in suturing time 
when using the restorelle Y mesh versus the restorelle dual flat mesh at the time of 
laparoscopic and robotic-assisted laparoscopic sacrocolpopexy. 
 
 
 
 
 
 
 
 

 
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Hypothesis: Suturing time when using the restorelle Y mesh will be faster than when 
using the restorelle dual flat mesh at the time of laparoscopic and robotic-assisted 
laparoscopic sacrocolpopexy. 
 
Study Design: Randomized single-blind prospective clinical trial 
 
Primary Outcomes:  
1. Total Suturing time for mesh placement = time from insertion of Y mesh or first 
flat mesh arm into pelvis to last sacral suture placed 
2. Total OR time = operating room time of entry and exit 
3. Total Case time = Incision to end of closure 
 
Secondary Outcomes:  
1. Intraoperative, peri-operative and post-operative complications 
2. Hospital costs (Y mesh v. dual mesh and stratified by RA LSC v. LSC) 
3. Post-operative patient outcomes at 6 weeks, 6 months, 12 months and 24 months 
• Pelvic Organ Prolapse Quantification (POPQ) system (standardized 
quantification of prolapse established by the International Continence 
Society) – Required at 6 months; Optional but encouraged at 12 and 24 
months. 
• Pelvic Floor Dysfunction Inventory (PFDI-20) – Required pre-operatively 
and at 6 weeks, 6, 12 and 24 months. 
 
Study Population: Study subjects will be recruited from patients that present to the Center 
of Urogynecology and Pelvic Floor Disorders in the Department of Obstetrics and 
Gynecology at the Cleveland Clinic main campus, Hillcrest Hospital and Fairview 
Hospital, and their surgeries will be performed at either one of these sites. 
 
Inclusion Criteria: 
• Age ≥ 18, who are to undergo laparoscopic or robotic laparoscopic 
sacrocolpopexy for pelvic organ prolapse 
• Other concomitant laparoscopic or prolapse and anti-incontinence procedures 
(e.g., laparoscopic supracervical hysterectomy, cystocele repair, rectocele repair 
or mid-urethral sling procedures) will be performed at the primary surgeon’s 
discretion. 
Exclusion Criteria: 
• Inability to comprehend written and/or spoken English 
• Inability to provide informed consent 
• Medical illness precluding laparoscopy 
• Need for concomitant surgeries not related to pelvic organ prolapse or 
incontinence  
• Sacrocolpoperineopexy  
 

 
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Study Procedures: 
 
Study Identification and Recruitment 
Potential subjects will be identified by members of the Center for Urogynecology and 
Pelvic Reconstructive Surgery at the Cleveland Clinic main campus and Fairview 
Hospital. Eligible patients that agree to participate will be provided written informed 
consent administered by the collaborators listed on this IRB at the Cleveland Clinic main 
campus and Fairview Hospital.  
 
Randomization 
All subjects will be predetermined by their surgeon to undergo either a laparoscopic or 
robotic assisted laparoscopic sacrocolpopexy depending upon their clinical evaluation. 
The participants will then be randomized to either Y mesh or dual flat mesh 
sacrocolpopexy according to a computer-generated randomization schedule with random 
block sizes with the use of the SAS statistical software package (SAS Institute, Cary, 
NC). Randomization will be carried out by provider. All patients will be blinded to their 
assignment.    
 
Office Interventions 
In addition to a standardized evaluation including the history and physical examination, 
patients will be asked to complete the Pelvic Floor Distress Inventory (PFDI-20) 
questionnaire at the pre-operative visit as well as the 6 week, 6, 12 and 24 month 
postoperative visit. Completion of these questionnaire is the only additional assessment 
that is specific to participation in this study and is not usually included as part of the 
standard care of sacrocolpopexy. It should take no more than 10-15 minutes to complete 
the questionnaire. The study subjects will not be exposed to any additional risk by 
participating in this study except for the inconvenience of completing the questionnaire.  
 
Surgical Interventions 
Laparoscopic sacrocolpopexy  will be performed using four ports: an umbilical port for 
the laparoscope, two ports (either 5 or 10/12 mm) in the bilateral lower quadrants, and 
one 5-mm port placed at the level of the umbilicus, lateral to the rectus muscle on either 
side for retraction. The robotic-assisted hysterectomy will be performed using the da 
Vinci Surgical System (Intuitive Surgical Inc., Sunnyvale, CA, USA) using five ports: a 
12mm umbilical port for the laparoscopic, two 8 mm robotic ports placed 2cm inferior 
and 9-10cm lateral to the umbilicus bilaterally, an 8mm robotic port placed in the left 
axillary line at the level of the umbilicus, and a 8mm or 10/12mm accessory port either in 
the right upper quadrant approximately 3cm distal from the costal margin, or in the right 
lower quadrant, 2cm above and medial to the anterior superior iliac spine.  
 
If a supracervical hysterectomy is to be performed, it will be done in a standard fashion. 
A uterine manipulator will be placed inside of the uterus. The round ligaments will be 
transected using cautery. The fallopian tubes and ovaries will be left in situ or removed at 
the time of hysterectomy depending upon the preoperative decision made between the 
surgeon and patient. The uterine arteries and cardinal ligaments will be cauterized 

 
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laparoscopically. The uterus will be amputated at the level of the internal cervical os and 
the endocervical canal will be cauterized.  
 
The sacrocolpopexy will also be performed and in a standard fashion. An end-to-end 
anastomosis (EEA) sizer will be placed in the vagina for manipulation of the apex as well 
as in the rectum for delineation of the rectovaginal septum. First, the presacral dissection 
will be performed with a longitudinal peritoneal incision over the sacral promontory and 
there is identification of the anterior longitudinal ligament. Dissection is then done 
caudally through the peritoneum and subperitoneal fat down to the level of the posterior 
cul-de-sac. The vagina is elevated cephalad using the EEA sizer and the peritoneum 
overlying the anterior vaginal apex is incised transversely, and the bladder is dissected off 
the anterior vagina using sharp dissection, creating a 4 to 5 cm pocket. If this plane is 
difficult to establish, the bladder will be filled in a retrograde fashion to find the correct 
dissection plane. Similarly, the peritoneum overlying the posterior vagina is incised, and 
dissection is then done overlying the vagina and extending into the posterior cul-de-sac, 
creating a 4 to 5 cm pocket. Once dissection is complete, the mesh graft is prepared. 
Subjects will have been randomized to either one of two mesh grafts: 
 
1. Restorelle Y mesh 
• The mesh is introduced into the pelvis through one of the ports.  
• First, either then anterior or the posterior arm is fixed to the anterior or posterior 
vaginal wall using 5 delayed- absorbable (PDS) No. 2-0 sutures in an interrupted 
fashion, 1 to 2 cm apart from each other.  
• The opposing arm of the graft is then attached to either the anterior or posterior 
vaginal wall, depending on which arm was placed first, in a similar fashion using 
5 delayed- absorbable (PDS) No. 2-0 sutures in an interrupted fashion, 1 to 2 cm 
apart from each other.  
• The stem portion of the graft is then brought to the sacral promontory and sutured 
to the anterior longitudinal ligament using 2 permanent (prolene) No. 0 sutures. 
The excess mesh is then trimmed.  
 
2. Restorelle dual flat mesh: 2 pieces of 15 x 4 cm mesh 
• One mesh arm is introduced into the pelvis through one of the ports. 
• The arm is fixed to the anterior or posterior vaginal wall using 5 delayed- 
absorbable (PDS) No. 2-0 sutures in an interrupted fashion, 1 to 2 cm apart from 
each other.  
• The second mesh arm is then introduced into the pelvis through one of the ports. 
• The arm is fixed to either the anterior or posterior vaginal wall, depending on 
where the first arm was placed, using 5 delayed- absorbable (PDS) No. 2-0 
sutures in an interrupted fashion, 1 to 2 cm apart from each other.  
• The two arms are then brought to the sacral promontory and sutured together to 
the anterior longitudinal ligament using 2 permanent (prolene) No. 0 sutures. The 
excess mesh is then trimmed.  
 
The peritoneum is then closed over the exposed graft with absorbable suture.  

 
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Routine cystoscopy will also be performed in order to assess for lower urinary tract 
injury. A vaginal exam is performed, and an anterior and/or posterior colporrhaphy and 
perineorrhaphy are performed if needed. Anti-incontinence procedures may also be 
performed if needed.  
 
**In laparoscopic cases, all suturing will be done extracorporeally while intracorporeal 
knot-tying technique will be performed in robot assisted laparoscopic cases.  
 
Data Collection & Management: 
 
Preoperative data will include the following: 
• Patient age, race, vaginal parity, menopausal sate, BMI, prior prolapse surgery, 
preoperative prolapse stage  
• PFDI-20  
• Labs (Hb/Hct) 
 
Data points recorded during the procedure will include:  
• Total OR time = operating room time of entry and exit 
• Total Case time = time from incision to closure  
• Total Suturing time = time from insertion of Y mesh or first flat mesh arm into 
pelvis to last sacral suture placed 
• Level of surgeon performing suturing: Attending v. Fellow v. Both 
• Concomitant procedures 
o Hysterectomy – Supracervical or Total 
o Anterior Colporrhaphy 
o Posterior Colporrhaphy 
o Perineorrhaphy 
o Midurethral Sling 
• Estimated blood loss 
• Intraoperative complications 
o EBL > 500cc 
o Vascular Injury 
o Cystotomy 
o Ureteral Injury 
o Bowel Injury - small bowel, large bowel, rectal 
 
Postoperative data will include the following: 
• Days in the hospital 
• 6-week postoperative visit: PFDI-20  
• 6-month postoperative visit (Required): POP-Q exam (performed by a provider 
blinded to the mesh used at the time of the procedure) 
• 12 month, 24 month postoperative visit (Optional): POP-Q exam (performed by a 
provider blinded to the mesh used at the time of the procedure) 
• 6-month, 12-month, 24-month postoperative visit: PFDI-20  

 
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• At 6, 12 and 24-months: Review of electronic medical record (inpatient notes, d/c 
summary, ER visits), assessing for postoperative complications  
o Reoperation for immediate complications = reoperation within 30 days of 
surgery 
o Abdominal Wound infection = fascial, subcutaneous, cutaneous infection 
requiring antibiotic treatment 
o Hematoma = intrapelvic/abdominal 
o Vaginal cuff cellulitis/Pelvic Abscess = requiring IV/PO antibiotic therapy 
and/or transvaginal, trangluteal or percutaneous drainage 
o DVT/PE = diagnosed with Doppler US or CT scan 
o Reoperation for SUI with pubovaginal sling (synthetic or fascial), 
colposuspension, injection with periurethral bulking agents 
o Reoperation for mesh exposure 
o Reoperation for recurrent POP 
o Bowel Injury/Bowel Obstruction = enterotomy, perforation, ileus, 
partial/complete obstruction 
o Port site or incisional hernia 
o Need for any radiologic imaging 
o Lower urinary tract injury = bladder, ureteral 
o Neurologic Injury = brachial plexus, abdominal wall (ilioinguinal, 
iliohypogastric), lower extremity (femoral, sciatic, common peroneal) 
o Pulmonary complications = pneumonia, pulmonary hypertension, 
pulmonary edema within 14 days of surgery 
o Cardiac = ACS, MI, HF within 14 days of surgery 
o Postoperative ICU admission 
 
Protection of each subject’s personal health information will be a priority in this study. 
One master excel file containing subject personal information including name and 
medical record number will be kept in a password-protected file, on a designated 
protected research drive on a password-protected computer in a locked office at the 
Cleveland Clinic. In that file, each subject will be assigned a subject identification 
number that will be used for the purposes of data collection in order to de-identify 
subjects.  
 

 
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All paper forms used for data collection will be kept in a research cabinet dedicated to 
this project which will be locked at all times, in a locked office at the Cleveland Clinic. 
All forms will contain de-identified information – identification numbers will correspond 
to the subjects listed in the master excel file.  
 
All study data will be transferred and managed electronically using REDCap (Research 
Electronic Data Capture). Each subject will be entered into REDCap using the assigned 
identification number from the master excel file. REDCap is a secure, web-based 
application designed to support data capture for research studies, providing user-friendly 
web-based case report forms, real-time data entry validation, audit trials, and a de-
identified data export mechanism to common statistical packages. They system was 
developed by a multi-institutional consortium which was initiated at Vanderbilt 
University and includes the Cleveland Clinic. The database is hosted at the Cleveland 
Clinic Research Datacenter in the JJN basement and is managed by the Quantitative 
Health Sciences Department. The system is protected by a login and Secure Sockets 
Layers (SSL) encryption. Data collection is customized for each study as based on a 
study-specific data dictionary defined by the research team with guidance from the 
REDCap administrator in Quantitative Health Sciences at the Cleveland Clinic.  
 
Analysis Plan: 
There will be 4 arms to this study: laparoscopic (robotic-assisted and conventional) 
sacrocolpopexy with Y mesh and laparoscopic (robotic-assisted and conventional) 
sacrocolpopexy with dual flat mesh. Subjects will be chosen based on surgeon preference 
to either undergo RA LSC ASC or conventional LSC ASC. They will then be 
randomized to either a Y mesh arm or a Dual Mesh arm. We determined that 9 subjects in 
each arm were needed to detect a difference of 30 minutes or more in suturing time 
between the two groups with 80% power and a significance level of .05. We will account 
for potential subject drop out and loss to follow-up as well as unforeseen factors in 
recruiting and will plan to recruit 15 subjects to each arm, for a total of 60 subjects.  
 
 
 
 
 
 
 
 
We will use descriptive statistics to show our demographic and baseline data: categorical 
variables will be presented as n/N (%) with 95% confidence intervals and continuous 
variables will be presented as mean+/-SD [range]. Y mesh and dual mesh will be 
compared between the two groups (Y mesh LSC + RA LSC v. Dual mesh LSC + RA 
LSC). With a continuous outcome and two categorical independent factors, a two-way 
60 Subjects 
30 RA LSC ASC 
30 LSC ASC 
15 RA LSC ASC 
Y Mesh  
15 RA LSC ASC 
Dual Mesh 
15 LSC ASC 
Y Mesh 
15 LSC ASC 
Dual Mesh 
Randomization

 
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analysis of variance will be used to evaluate differences between the groups. The results 
will be presented in a standard ANOVA table, which should be sufficient to determine if 
differences exist. A linear regression will be done to demonstrate actual changes in 
surgical time attributed to each variable. We will control for LSC ASC and RA LSC ASC 
by performing a logistic regression. Cost utility analysis will be used to compare the 
differential mean operating room costs with incremental cost effectiveness ratios (ICERs) 
calculated as appropriate.    
 
Summary of tasks for study: 
 
Preop 
O
R 
6 wk 
postop 
6 mo 
f/u 
12 
mo 
f/u 
24 
mo 
f/u 
Informed consent 
X 
 
 
 
 
 
Demographic data 
X 
 
 
 
 
 
Randomization 
X 
 
 
 
 
 
PFDI-20 
X 
 
    X 
X 
X 
X 
POP-Q 
X 
 
 
X 
X1 
X1 
OR data collection sheet 
 
X 
 
 
 
 
Review of d/c summary, 
chart, postop Hct, 
complications  
(ER visits, etc) 
 
 
X 
X 
X 
X 
1. POP-Q – Optional but encouraged at 12 and 24 months. 
References:  
1. Ganatra AM, Rozet F, Sanchez-Salas R, et al. The current status of laparoscopic 
sacrocolpopexy: A review. Eur Urol 2009;55(5):1089-1103.  
2. Walters MD, Ridgeway BM. Surgical treatment of vaginal apex prolapse. Obstet 
Gynecol 2013, 121(2):354-373. 
3. Porges RF & Smilen SW. Long term analysis of the surgical management of 
pelvic floor support defect. Am J Obstet Gynecol 1994;171:1518–1528. 
4. Birch C. The use of prosthetics in pelvic reconstructive surgery. Best Pract Res 
Clin Obstet Gyn 2005;19(6):979-991.  
5. Chu CC & Welch L. Characterisation of morphological and mechanical properties 
of surgical mesh fabrics. J Biomed Res 1985;19:903–916. 
6. Kaupp HA, Matulewicz TJ & Lattimer GL. Graft infection or graft reaction? Arch 
Surg 1979;114:1419-1423. 
7. Weinbraum AA, Ekstein P, Ezri T. Efficiency of the operating room suite. Am J 
Surg 2003;185:244-250.