Sacrocolpopexy – Understanding the Procedure

1. Sacrocolpopexy – Understanding the Procedure July 2010

2. Steps in this Guide • Introduction to our Sacrocolpopexy tip • Instruments and accessories • Typical Procedure Steps • Total or Supracervical Hysterectomy for Uterine Prolapse • Develop the bladder flap interiorly • Develop the rectovaginal septum • Develop the Presacral Space and expose anterior longitudinal ligament • Attach mesh to the Anterior vaginal wall • Attach mesh to the posterior vaginal wall • Adjust mesh tension • Attach the mesh to the sacrum • Close the peritoneum • Uterine Morcellation for Supracervical Hyst • Surgical site closure. • Conclusion associated with our Sacrocolpopexy tip • This procedure is provided as a guide for our CooperSurgical Sales team only. It is only a guide to share with our internal team to enhance their understanding of how and why these procedures are being performed. Page 2

3. Introduction • The Sacrocolpopexy tip is connected to either the RUMI or RUMI Arch Manipulators. • In conjunction with these 2 manipulators, the user will get the only device intended specifically for laparotomy as well as laparoscopic sacrocolpopexy’s on the market today. • Each device is 3.8cm wide, by 11.4 cm long. (1.5” x 4.5”) • The Part number is Sacro-1 which gets you 3 in a box Page 3

4. Why this device is important • The SACRO-1: Sacrocolpopexy tip is a device that will expedite the attachment of mesh to the Anterior Vaginal Wall and Posterior Vaginal Wall during the procedure. • This is a procedure that can take anywhere from 1.5 hours up to 4 hours. • Therefore the UPS provides static holding power for the length of the procedure. Page 4

5. EEA Sizers Other forms of vaginal stents such as: Lucite stents Narrow malleable retractors, Or, Breisky Navratil retractors. What your surgeons are using today Page 5

6. Introduction of the Procedure • Sacrocolpopexys are an approach to surgical correction of vaginal vault or uterine prolapse by resupporting the vagina to the sacrum using a polypropylen mesh. Page 6

7. Introduction to the procedure Continued • Due to the difficulty of using traditional laparoscopy for suturing and dissection of the presacral space, an open approach is still widely used. • Since Sacrocolpopexys are intended for advanced vaginal vault repair or uterine prolapse are performed via laparotomy. Patient Positioning – Same as with a TLH • As with a TLH, the patient is placed on the table in the supine position with moderate to steep trandelenburg. • A modified dorsal lithotomy position is utilized. – the patient’s legs are separated and knees flexed using adjustable leg stirrups with boots. • Since it is identical to the TLH procedure, having the stirrups pushed in 1 inch from the end of the table rail provides us with just enough room to place our UPS on the end of that table. Page 7

8. Surgical Prep with the UPS • Once it is determined that our Uterine Positioning System will be utilized, and the patient is on the table, it is time to put the UPS on the table • After placing a chuck or towel over the UPS, the patient’s abdomen, upper thighs, vagina and peri-anal regions are sterilely prepped. • Draping of the UPS is next and then all other drapes are introduced to the sterile field. • Then typically a 16 Fr Foley catheter for bladder drainage is inserted. Page 8

9. Sacrocolpopexy • If necessary a hysterectomy is performed prior. • It is time to start the Sacrocolpopexy by inserting the Sacrocolpopexy tip onto either the RUMI or RUMI Arch. • The Sacrocolpopexy tip gets attached the same way a RUMI uterine tip gets inserted. • Simply rotate the tip clockwise while pushing gently Page 9

10. Starting the Sacrocolpopexy With the SACRO-1 inserted into the vagina the surgeon is able to manipulate the entire vaginal vault into the surgical field. In many instances it may benefit the procedure to place an EEA sizer into the rectum at the same time to allow for clear identification of the rectovaginal septum. Page 10

11. It is time to start the procedure • In a laparoscopic procedure the patient is in Trendelenburg position, this moves the small bowel and omentum out of the operative field. - including sacrum – an provides a clear path for the other cannulae • The camera port (typically a 12 mm cannula, is placed at the umbulicus. ) • 2 or 3 other ports will be utilized based on Surgeon preference. • Pelvic inspection takes place. • Retract small bowel if necessary • Locate Ureters, Sacral promontory, the midline with the sigmoid colon retracted, the middle sacral vessels and the iliac vessels. Page 11

12. If an Intuitive Surgical da Vinci Robot will be used • This is typically when the patient cart gets docked. • If docking within the patients legs, it is imperative that they do not come in contact with the UPS during docking. • A way to remedy this would be to allow the docking of the patient bedside cart only when the UPS is not connected to the RUMI or RUMI Arch manipulator. • Once in place the Surgical team will connect each arm; camera first, instrument arms are second. • Other docking tips per Intuitive are as follows: • Foster good cooperation in the OR • Work with your product rep • Start with one port at a time • Allow extra time until you have mastered the setup • Use an extra-long cannula for the camera port (For this procedure) Page 12

13. Other necessary typical instruments and accessories • Bipolar scissors/dissecting forceps • For Grasping, dissectin, bipolar coagulation • Monopolar curved scissors • Dissection, monopolar coagulation • Permanent Cautery Spatula, Permanent Cautery Hook. • Suturing Options: • Two large needle drivers • One large needle drive and one Suture cut needle driver. • 3rd port options: • Grasper, atraumatice tissue grasping and manipulation of the mesh • Forceps, for atraumatic tissue grabbing • Bipolar forceps for grasping dissecting and bipolar cautery. • Suction / irrigator • Endoscopic scissors • Additional graspers. Page 13

14. Other accessories • 4 x 4 sponges • Typically used today: Wide-weave polypropylene mesh • Either a predetermend Y Shape such as the intePro (From InterGraft) or large Pore Polypropylene Y-Sling, or • Configure a Y shaped piece of mesh from available meshes. • Typical Suture Material • Vaginal cuff closure • 0 Vicryl, on CT-1 needle cut to 12” length (must use 12 mm port due to CT-1 needle size) • Attaching mesh to anterior/posterier and sacrum • CV-2 Gore-Tex on THX-26 needle for attaching mesh to vagina and sacrum • 12-20” (Start with short sutures, and increase length with increasing experience) • Use 12” for sacral suture • Closing the peritoneum • 2-0 Vicryl on an SH needle cut to 14” long to close peritoneum We’ll go grab a picture from the Internet of a package of Vicral suture material. Page 14

15. Considerations prior to mesh attachment • Confirm Rectovaginal Septum (Separation) • Develop the Presacral Space and Expose the Anterior Longitudinal ligament. • Key land marks: • Sacral Promentory • Ilian vessels • Ureters • Anterior longitudinal ligament • Middle sacral vessels • Vaginal Vault • Sigmoid Colon Page 15

16. Attaching the Mesh Anterially • The Surgeon will attach the mesh to the anterior portion of the vagina first. • Typically they will place the distal and lateral anchoring sutures first (The corners) • Secure the mesh to the anterior vaginal wall with 6 to 9 sutures to distribute the forneces evenly. • After the anterior mesh has been attached the Surgeon will roll the sacral end of the mesh and hold it anteriorly. This allows the posterior mesh to drape over the posterior vaginal wall and facilitates posterior mesh placement. Page 16

17. Attaching the Mesh to the Posterior Vaginal Wall • Attach the mesh to the posterior vaginal wall • The key for the surgeon is to minimize slack in the mesh and help with posterior exposure. • It is vital to have equal tension on the anterior and posterior vaginal wall. • 6 to 9 sutures are used on the posterior side as well. • The Posterior mesh continuous to the sacrum • Place the distal (corner) sutures first. • During suturing the surgeon will make certain to not throw sutures all the way through the vaginal wall. Page 17

18. Adjusting Mesh Tension • The Mesh should be attached to the sacrum without undue tension • Confirm adequate support of the vagina with/without the cervix • To confirm appropriate tension, bring proximal (sacral end of the mesh to planned location of most distal/inferior (sacral) suture. • Correct adjustment of the mesh length will avoid undue tension on the vagina and potential for tight band that could result in an internal hernia. • The SACRO-1 is typically removed when determining mesh length/tension. • Instead the assistant will place fingers in the vagina to help gauge mesh placement and avoid undue tension. Page 18

19. Attaching Mesh to the Sacrum • Working inferiorly to superiorly, secure mesh to the anterior longitudinal ligament of the sacrum • Avoid middle sacral vessels or presacral venous plexus • Additional sutures are placed superiorly to allow for adequate visualization of the sacrum/adjacent structures. • Trim excess portion of the mesh at the superior aspect and remove. Page 19

20. Completing the procedure • Close the Peritoneum • Potentially morcelate the Uterus at this time if Hysterectomy was performed. • Remove and close Port sites with the CooperSurgical CT closure. Page 20

21. Conclusion • The SACRO-1 Sacrocolpopexy is a device that will expedite the attachment of mesh to the Anterior Vaginal Wall and Posterior Vaginal Wall during the procedure. • This is a procedure that can take anywhere from 1.5 hours up to 4 hours. • Your Surgeons need to use something from an EEA Sizer, to a lucite stent or narrow malleable Breisky retractor. The SACRO- 1 in conjunction with the RUMI, or RUMI Arch and a UPS is a much better solution Page 21

22. Questions Page 22