Randomized Trial of Y Mesh vs Dual Mesh

• Sponsor: The Cleveland Clinic (Other)
• Overall Status: Completed
• CT.gov ID: NCT02156687
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arms: 2
• Actual Duration (Months): 71.6
• Patients Per Site Per Month: 0.8

Study Details

Study Description

Brief Summary

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.

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.

Condition or Disease	Intervention/Treatment	Phase
Prolapse	Device: Y mesh; Device: Dual flat mesh	N/A

Detailed Description

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 Case time = Incision to end of closure

Secondary Outcomes:

Post-operative patient outcomes at 24-months

• Pelvic Floor Dysfunction Inventory (PFDI-20)

• Pelvic Organ Prolapse Distress Inventory (POPDI)

• Colorectal Anal Distress Inventory (CRADI)

• Urogenital Distress Inventory (UDI)

• Objective Recurrence (POP-Q)

• Subjective Recurrence (vaginal bulge)

• Reported mesh erosion

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.

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 Investigational Research Board (IRB) proposal at Cleveland Clinic Main campus and Fairview Hospitals.

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, 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 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.

1. 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. 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Prospective Randomized Trial Comparing Restorelle Y Mesh vs. Restorelle Dual Flat Mesh for Laparoscopic and Robotic-assisted Laparoscopic Sacrocolpopexy
• Actual Study Start Date: Apr 14, 2014
• Actual Primary Completion Date: Nov 7, 2019
• Actual Study Completion Date: Apr 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cololast, Inc. Restorell Y mesh Y mesh	Device: Y mesh; Y mesh; Other Names: Cololast, Inc. Restorell Y mesh
Active Comparator: Coloplast, Inc. Restorelle Dual flat mesh Dual flat mesh	Device: Dual flat mesh; Dual flat mesh; Other Names: Coloplast, Inc. Restorelle Dual flat mesh

Outcome Measures

Primary Outcome Measures

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 [one day intraoperative]

2. Total OR Time = Operating Room Time of Entry and Exit [one day intraoperative]

Secondary Outcome Measures

1. Post-operative Mean Difference POPDI at 24 Months [24 months]

   Mean difference between baseline (pre-procedure) and 24-months post-procedure. The POPDI is a six-item measure from the PFDI-20 which measures 6 different pelvic organ prolapse symptoms and degree of bother. The scale exists from 0-100 (0=no symptoms, 100=worse symptoms).

2. Postoperative Mean Difference CRADI at 24 Months [24 months]

   Mean difference between baseline (pre-procedure) and 24-months post-procedure. The CRADI is a eight-item measure from the PFDI-20 which measures 8 different pelvic organ prolapse symptoms and degree of bother. The scale exists from 0-100 (0=no symptoms, 100=worse symptoms).

3. Postoperative Mean Difference UDI at 24 Months [24 months]

   Mean difference between baseline (pre-procedure) and 24-months post-procedure. The UDI is a six-item measure from the PFDI-20 which measures 6 different pelvic organ prolapse symptoms and degree of bother. The scale exists from 0-100 (0=no symptoms, 100=worse symptoms).

4. Postoperative Subjective Recurrence at 24 Months [24 months]

   Subjective Recurrence was defined as patients who complained of vaginal bulge symptoms (Question #3 on the PFDI-20).

5. Postoperative Objective Recurrence at 24 Months [24 months]

   Objective Recurrence

6. Reported Mesh Erosion at 24 Months [24 months]

   Mesh Erosion was defined as presence of eroded mesh in the vagina on examination postoperatively up to 24-months after surgery.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cleveland Clinic	Cleveland	Ohio	United States	44195

Sponsors and Collaborators

• The Cleveland Clinic

Investigators

• Principal Investigator: Cecile Unger, M.D., The Cleveland Clinic

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 26, 2015

More Information

Publications

None provided.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02156687
• Other Study ID Numbers: 14-354
• First Posted: Jun 5, 2014
• Last Update Posted: Nov 24, 2020
• Last Verified: Nov 1, 2020

• Additional relevant MeSH terms: Prolapse

Study Results

Participant Flow

Arm/Group Title	Coloplast, Inc. Restorelle Y Mesh	Coloplast, Inc. Restorelle Dual Flat Mesh
Arm/Group Description	Subjects implanted with Coloplast, Inc. Restorelle Y mesh at the time of minimally invasive sacrocolpopexy.	Subjects implanted with Coloplast, Inc. Restorelle Dual flat mesh at the time of minimally invasive sacrocolpopexy.
Period Title: Overall Study
STARTED	30	29
COMPLETED	20	24
NOT COMPLETED	10	5

Baseline Characteristics

Arm/Group Title	Cololast, Inc. Restorell Y Mesh	Coloplast, Inc. Restorelle Dual Flat Mesh	Total
Arm/Group Description	Y mesh Y mesh: Y mesh	Dual flat mesh Dual flat mesh: Dual flat mesh	Total of all reporting groups
Overall Participants	30	29	59
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	60.3 (7.3)	62.4 (8.1)	61 (8)
Sex: Female, Male (Count of Participants)
Female	30 100%	29 100%	59 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	2 6.7%	2 6.9%	4 6.8%
White	28 93.3%	27 93.1%	55 93.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Body Mass Index (BMI) (kg/m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/m^2]	28.9 (3.5)	28.2 (4.2)	28.5 (3.9)
Tobacco use (Count of Participants)
Count of Participants [Participants]	2 6.7%	3 10.3%	5 8.5%
Parity (pregnancies) [Median (Full Range) ]
Median (Full Range) [pregnancies]	3	2	3
Prior prolapse surgery (Count of Participants)
Count of Participants [Participants]	15 50%	15 51.7%	30 50.8%
Prolapse Stage 1 (Count of Participants)
Count of Participants [Participants]	0 0%	0 0%	0 0%
Prolapse Stage 2 (Count of Participants)
Count of Participants [Participants]	9 30%	10 34.5%	19 32.2%
Prolapse Stage 3 (Count of Participants)
Count of Participants [Participants]	20 66.7%	17 58.6%	37 62.7%
Prolapse Stage 4 (Count of Participants)
Count of Participants [Participants]	1 3.3%	2 6.9%	3 5.1%

Outcome Measures

1. Primary Outcome

Title	Total Suturing Time for Mesh Placement = Time From Insertion of Y Mesh or First Flat Mesh Arm Into Pelvis to Last Sacral Suture Placed
Time Frame	one day intraoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coloplast, Inc. Restorelle Y Mesh	Coloplast, Inc. Restorelle Dual Flat Mesh
Arm/Group Description	Y mesh Y mesh: Y mesh	Dual flat mesh Dual flat mesh: Dual flat mesh
Measure Participants	30	29
Mean (Standard Deviation) [minutes]	46 (14.7)	46.3 (12.3)

2. Primary Outcome

Title	Total OR Time = Operating Room Time of Entry and Exit
Time Frame	one day intraoperative

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coloplast, Inc. Restorelle Y Mesh	Coloplast, Inc. Restorelle Dual Flat Mesh
Arm/Group Description	Y mesh Y mesh: Y mesh	Dual flat mesh Dual flat mesh: Dual flat mesh
Measure Participants	30	29
Mean (Standard Deviation) [minutes]	204.2 (52.8)	204.5 (43.7)

3. Secondary Outcome

Title	Post-operative Mean Difference POPDI at 24 Months
Description	Mean difference between baseline (pre-procedure) and 24-months post-procedure. The POPDI is a six-item measure from the PFDI-20 which measures 6 different pelvic organ prolapse symptoms and degree of bother. The scale exists from 0-100 (0=no symptoms, 100=worse symptoms).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coloplast, Inc. Restorelle Y Mesh	Coloplast, Inc. Restorelle Dual Flat Mesh
Arm/Group Description	Y mesh Y mesh: Y mesh	Dual flat mesh Dual flat mesh: Dual flat mesh
Measure Participants	20	24
Mean (Standard Deviation) [score on a scale]	-32.5 (24.1)	-40.7 (26.9)

4. Secondary Outcome

Title	Postoperative Mean Difference CRADI at 24 Months
Description	Mean difference between baseline (pre-procedure) and 24-months post-procedure. The CRADI is a eight-item measure from the PFDI-20 which measures 8 different pelvic organ prolapse symptoms and degree of bother. The scale exists from 0-100 (0=no symptoms, 100=worse symptoms).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coloplast, Inc. Restorelle Y Mesh	Coloplast, Inc. Restorelle Dual Flat Mesh
Arm/Group Description	Y mesh Y mesh: Y mesh	Dual flat mesh Dual flat mesh: Dual flat mesh
Measure Participants	20	24
Mean (Standard Deviation) [score on a scale]	-24.2 (20.6)	-20.2 (16.1)

5. Secondary Outcome

Title	Postoperative Mean Difference UDI at 24 Months
Description	Mean difference between baseline (pre-procedure) and 24-months post-procedure. The UDI is a six-item measure from the PFDI-20 which measures 6 different pelvic organ prolapse symptoms and degree of bother. The scale exists from 0-100 (0=no symptoms, 100=worse symptoms).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coloplast, Inc. Restorelle Y Mesh	Coloplast, Inc. Restorelle Dual Flat Mesh
Arm/Group Description	Y mesh Y mesh: Y mesh	Dual flat mesh Dual flat mesh: Dual flat mesh
Measure Participants	20	24
Mean (Standard Deviation) [score on a scale]	-39.0 (27.0)	-33.2 (18.9)

6. Secondary Outcome

Title	Postoperative Subjective Recurrence at 24 Months
Description	Subjective Recurrence was defined as patients who complained of vaginal bulge symptoms (Question #3 on the PFDI-20).
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coloplast, Inc. Restorelle Y Mesh	Coloplast, Inc. Restorelle Dual Flat Mesh
Arm/Group Description	Y mesh Y mesh: Y mesh	Dual flat mesh Dual flat mesh: Dual flat mesh
Measure Participants	20	24
Count of Participants [Participants]	2 6.7%	2 6.9%

7. Secondary Outcome

Title	Postoperative Objective Recurrence at 24 Months
Description	Objective Recurrence
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coloplast, Inc. Restorelle Y Mesh	Coloplast, Inc. Restorelle Dual Flat Mesh
Arm/Group Description	Y mesh Y mesh: Y mesh	Dual flat mesh Dual flat mesh: Dual flat mesh
Measure Participants	20	24
Count of Participants [Participants]	5 16.7%	4 13.8%

8. Secondary Outcome

Title	Reported Mesh Erosion at 24 Months
Description	Mesh Erosion was defined as presence of eroded mesh in the vagina on examination postoperatively up to 24-months after surgery.
Time Frame	24 months

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Coloplast, Inc. Restorelle Y Mesh	Coloplast, Inc. Restorelle Dual Flat Mesh
Arm/Group Description	Y mesh Y mesh: Y mesh	Dual flat mesh Dual flat mesh: Dual flat mesh
Measure Participants	20	24
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	Adverse events were collected up to 6 weeks after index surgery
Arm/Group Title	Coloplast, Inc. Restorelle Y Mesh		Coloplast, Inc. Restorelle Dual Flat Mesh
Arm/Group Description	Y mesh Y mesh: Y mesh		Dual flat mesh Dual flat mesh: Dual flat mesh
All Cause Mortality
	Coloplast, Inc. Restorelle Y Mesh		Coloplast, Inc. Restorelle Dual Flat Mesh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/29 (0%)
Serious Adverse Events
	Coloplast, Inc. Restorelle Y Mesh		Coloplast, Inc. Restorelle Dual Flat Mesh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/29 (0%)
Other (Not Including Serious) Adverse Events
	Coloplast, Inc. Restorelle Y Mesh		Coloplast, Inc. Restorelle Dual Flat Mesh
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/30 (0%)		0/29 (0%)

Limitations/Caveats

The biggest limitation in this study was lost to follow-up; however, this limitation was mitigated apriori by considering potential lost to follow-up in our power analysis.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.