Randomized Trial of Y Mesh vs Dual Mesh
Condition: Prolapse
MeSH terms: Prolapse
Study type: Interventional

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.
    

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.

        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. 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.
    

Intervention name(s): Y mesh; Dual flat mesh
Intervention type(s): Device; Device
Intervention description(s): Y mesh; Dual flat mesh
Other intervention name(s): Cololast, Inc. Restorell Y mesh; Coloplast, Inc. Restorelle Dual flat mesh
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment