A Prospective Randomized Trial Comparing Vaginal Hysterectomy and Laparoscopic Supracervical Hysterectomy at the Time of Sacrocolpopexy for the Treatment of Uterovaginal Prolapse
Phase: NA
Conditions: Vaginal Hysterectomy, Laparoscopic Supracervical Hysterectomy
Sponsor: The Cleveland Clinic

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A prospective randomized trial comparing vaginal hysterectomy and laparoscopic 
supracervical hysterectomy at the time of sacrocolpopexy for the treatment of 
uterovaginal prolapse  
 
Cecile A. Ferrando, MD MPH; Staff. Center for Urogynecology and Pelvic 
Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health Institute, Cleveland 
Clinic, Cleveland OH 
 
Marie Fidela R. Paraiso, MD; Professor, Center for Urogynecology and Pelvic 
Reconstructive Surgery; Obstetrics/Gynecology and Women’s Health Institute, Cleveland 
Clinic, Cleveland OH 
 
Shannon Wallace, MD; Staff. Center for Urogynecology and Pelvic Reconstructive 
Surgery; Obstetrics/Gynecology and Women’s Health Institute, Cleveland Clinic, 
Cleveland OH 
 
Amy Park, MD; Staff. Center for Urogynecology and Pelvic Reconstructive Surgery; 
Obstetrics/Gynecology and Women’s Health Institute, Cleveland Clinic, Cleveland OH 
 
 
Background and Significance: 
 
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 (Walters). Minimally invasive abdominal 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 (Ganatra).  
 
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. The surgery can be 
performed for uterovaginal prolapse or post-hysterectomy vaginal vault prolapse. In cases 
of uterovaginal prolapse, hysterectomy is often performed unless uterine preserving 
surgery is desired and a hysteropexy is performed. When concurrent hysterectomy is 
done, a supracervical or total approach may be taken.  
 
In 2014, there was a de facto change in practice patterns after the Food and Drug 
Administration advised against power morcellation for extraction of the uterine specimen 
after minimally invasive supracervical hysterectomy. At that time, surgeons performing 
prolapse surgery had to choose to continue performing concurrent supracervical 
hysterectomy at the time of sacrocolpopexy using an extended abdominal incision to 
remove the uterus. An alternative solution became to perform total vaginal hysterectomy 
followed by a combination of mesh attachment vaginally (to the vagina) and 
laparoscopically (to the sacrum) versus mesh attachment performed laparoscopically only 

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(to the vagina and sacrum). Very few studies have looked at the outcomes of these two 
ways to perform minimally invasive sacrocolpopexy with concurrent hysterectomy. One 
study published by Nosti et al. did compare the two groups retrospectively and found that 
there was no difference in mesh-related complications between the groups and that 
vaginal mesh attachment following vaginal hysterectomy decreased operative time 
significantly with no differences in intraoperative complications, reoperation for recurrent 
prolapse, and subjective or objective outcomes compared to concurrent supracervical 
hysterectomy (Nosti). In our practice, both techniques are currently used, and while we 
also believe there are no differences in complications and outcomes between the two 
modes of surgery, anecdotally our group feels that surgical time may be the same 
between the two types of prolapse repairs.  
 
 
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 (Weinbraum) 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 a mode of hysterectomy and 
technique for mesh attachment at the time of sacrocolpopexy that may make the entire 
procedure faster and more efficient.  
 
Given the sparse data that exist, it remains unclear if one type of concurrent hysterectomy 
and subsequent mesh attachment at the time of sacrocolpopexy is more efficient. 
Furthermore, because no prospective studies exist, we also do not know with any degree 
of certainty if one approach reduces the risk of intraoperative and postoperative mesh-
related complications as well as the risk of prolapse recurrence. Therefore, the primary 
objective of the proposed study is to determine the difference in surgical time between 
minimally invasive (laparoscopic) sacrocolpopexy performed with concurrent vaginal 
hysterectomy versus laparoscopic supracervical hysterectomy. The secondary objectives 
are to determine if there are differences in intraoperative adverse events and 
postoperative mesh-related complications and prolapse recurrence between the groups. 
 
 
Hypothesis: There is no clinically difference in surgical time in patients undergoing 
vaginal hysterectomy versus laparoscopic supracervical hysterectomy at the time of 
sacrocolpopexy  
 
Study Design: Randomized trial  
 
Primary Outcome: Surgical time defined as time of incision to time of sacrocolpopexy 
completion (abdominal incisions closed) 
 
Secondary Outcomes:  
1. Intraoperative, peri-operative and post-operative complications up to 6 weeks 
after surgery 

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2. Pelvic floor symptoms (urinary, bowel, prolapse, sexual function): PFDI, ISI, 
PISQ) at 6, 12, and 24 months 
3. Patient satisfaction (PGII) at 6, 12 and 24 months 
4. Prolapse recurrence at 12 and 24 months  
5. Mesh-related complication defined by mesh erosion on vaginal examination or 
report of reoperation for any type of sacrocolpopexy mesh excision within 24 
months of the index surgery 
 
 
Study Population: Study subjects will be recruited from patients that present to the Center 
for Urogynecology & Pelvic Reconstructive Surgery 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 sacrocolpopexy for uterovaginal 
prolapse and desire concurrent hysterectomy at the time of surgery 
• Other concomitant laparoscopic or prolapse and anti-incontinence procedures 
(cystocele repair, rectocele repair or mid-urethral sling procedures) will be 
performed at the primary surgeon’s discretion. 
• Patient’s must have an up-to-date PAP smear on record, or a PAP smear is 
performed in the office and verified to be normal pre-enrollment  
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  
• Patients desiring uterine preservation (hysteropexy) 
 
 
Study Procedures: 
 
Study Identification and Recruitment 
Potential subjects will be identified by members of the Center for Urogynecology & 
Pelvic Reconstructive Surgery at the Cleveland Clinic Main campus, Hillcrest Hospital 
and Fairview Hospital. Eligible patients who agree to participate will be provided written 
informed consent administered by the collaborators listed on this IRB. 
 
Randomization 

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All subjects will be predetermined by their surgeon to undergo a laparoscopic 
sacrocolpopexy. The participants will then be randomized to either concurrent vaginal 
hysterectomy or laparoscopic supracervical hysterectomy according to a computer-
generated randomization schedule with the use of the SAS statistical software package 
(SAS Institute, Cary, NC).  
 
Office Interventions 
All patients will be seen for a preoperative visit and then postoperatively at 6, 12 and 24 
months. The 6 month visit will be standard of care, the 12 month and 24 month visit will 
be a research visit. At each visit, a vaginal exam and a complete Pelvic Organ Prolapse 
Quantification (POP-Q) exam will be performed. In addition, patients will be asked to 
complete the Pelvic Floor Distress Inventory (PFDI-20), Incontinence Severity Index 
(ISI), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and 
Patient Global Impression of Improvement (PGII) questionnaires at the pre-operative 
visit as well as the 6, 12, and 24 month postoperative visits. Completion of these 
questionnaires 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 questionnaires. The study subjects will 
not be exposed to any additional risk by participating in this study except for the 
inconvenience of completing the questionnaires.  
 
Surgical Interventions 
The laparoscopic portions of the surgery will be performed using four ports: an umbilical 
port for the laparoscope (either 5 or 10/12mm), two ports (either 5, 8 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.  
 
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 
laparoscopically. The uterus will be amputated at the level of the internal cervical os and 
the endocervical canal will be cauterized. The specimen will be extracted in a 
laparoscopic endocatch bag and removed through an extended incision at the umbilicus at 
the end of the case. Dissection of the vagina anteriorly and posteriorly will be done 
laparoscopically with the use of an end-to-end anastomosis (EEA) sizer in the vagina. 
Dissection of the presacral space will also be done laparoscopically. Five to six 2-0 PDS 
sutures will be placed to secure the mesh to the anterior vagina as well as the posterior 
vagina for a total of 10-12 sutures on the vagina; the arm of the mesh will be secured to 
the anterior longitudinal ligament of the sacrum using two 0 Prolene sutures. The 
Coloplast® Restorelle Y mesh will be used for all cases. The peritoneum will be closed 
with 0 or 2-0 vicryl sutures.  
 
 

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If a vaginal hysterectomy is performed, it will be done in a standard fashion using a 
traditional clamp and suture technique starting at the uterosacral ligaments and ending 
with the utero-ovarian ligaments. The specimen will be extracted through the vagina. 
Dissection of the vagina anteriorly and posteriorly will be done vaginally. The mesh will 
be attached vaginally using five to six 2-0 PDS sutures on the anterior and posterior 
vagina for a total of 10-12 sutures on the vagina. The Coloplast® Restorelle Dual flat 
mesh will be used. The vagina will then be closed in two layers using 0 or 2-0 vicryl 
suture. Laparoscopic entrance will then be gained and set up will be done as described 
above. The presacral space will be dissected laparoscopically and the mesh attached to 
the anterior longitudinal ligament of the sacrum using two 0 Prolene sutures. The 
peritoneum will be closed with 0 or 2-0 vicryl sutures.  
 
 
Data Collection & Management: 
 
Preoperative data will include the following: 
• Patient age, race, vaginal parity, menopausal sate, BMI, comorbid conditions, 
tobacco use, preoperative prolapse stage, preoperaetive use of vaginal estrogen 
• PFDI-20, ISI, PISQ-12  
 
Data points recorded during the procedure will include:  
• Total OR time = operating room time of entry and exit 
• Surgical time = time from incision to end of sacrocolpopexy (abdominal incisions 
closed) 
• Total Case time = time from incision to end of procedure 
• Hysterectomy time= time from start of hysterectomy to end of hysterectomy 
• Concomitant procedures 
o Lysis of Adhesions >45 min 
o Anterior colporrhaphy 
o Posterior colporrhaphy 
o Perineorrhaphy 
o Midurethral sling 
o Other 
• Estimated blood loss 
• Intraoperative complications 
o Vascular Injury 
o Cystotomy 
o Ureteral Injury 
o Bowel Injury - small bowel, large bowel, rectal 
 
Postoperative data will include the following: 6, 12, 24 months 
• POP-Q exam (performed by a provider who did not perform the surgery)  
• Vaginal exam, inspection for mesh exposure 
• PFDI-20, ISI, PISQ-12 
• Assessment of use of postoperative vaginal estrogen  

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• 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 2 arms to this study: laparoscopic supracervical hysterectomy and 
sacrocolpopexy with Restorelle® Y mesh and vaginal hysterectomy and sacrocolpopexy 
using the Restorelle® Dual flat mesh.  
We determined that 30 subjects in each arm were needed to detect a difference of 30 
minutes or more (standard deviation 30 minutes) in surgical 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 35 subjects to each arm, for a total of 70 subjects.  
.  
 
 
 
 
 
 
 
 
 
 
 
70 Subjects 
35 Laparoscopic 
Supracervical 
Hysterectomy  
35 Vaginal 
Hysterectomy  
Randomization

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All statistical analyses will be done using jmp 14. 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]. The two types of hysterectomy (laparoscopic supracervical and vaginal) will 
be compared. With a continuous outcome and two categorical independent factors, a two-
way 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.  
 
 
Summary of tasks for study: 
 
Preop 
Day of 
Surgery 
6 mo  
12 mo  
24 mo  
Enrollment/Informed 
consent 
X 
 
 
 
 
Demographic data 
X 
 
 
 
 
PFDI-20 
X 
 
X 
X 
X 
ISI 
X 
 
X 
X 
X 
PISQ-12 
X 
 
X 
X 
X 
POP-Q 
X 
 
X 
X 
X 
Vaginal exam  
 
 
X 
X 
X 
Randomization 
 
X 
 
 
 
Intraoperative Data 
 
X 
 
 
 
Review of d/c summary, 
chart, complications  
(ER visits, etc) 
 
 
X 
 
 
References:  
1. Walters MD, Ridgeway BM. Surgical treatment of vaginal apex prolapse. Obstet 
Gynecol 2013;121(2):354-373. 
2. Ganatra AM, Rozet F, Sanchez-Salas R, et al. The current status of laparoscopic 
sacrocolpopexy: A review. Eur Urol 2009;55(5):1089-1103.  
3. Nosti PA, Carter CM, Sokol AI, et al. Transvaginal versus transabdominal 
placement of synthetic mesh at time of sacrocolpopexy. Fem Pelvic Reconstr Surg 
2016; 22(3):151-155. 
4. Weinbraum AA, Ekstein P, Ezri T. Efficiency of the operating room suite. Am J 
Surg 2003;185:244-250.