Comparison of Sacrospinous Ligament Fixation and Uterosacral Ligament Suspension for Apical Prolapse Surgery: A Randomized Clinical Trial

1. Objectives General objective To compare the surgical outcome between SSLF and modified USLS for apical fixation in women undergoing vaginal prolapse surgery Specific objectives 1) To compare the success rate of SSLF and modified USLS for apical fixation at 6 month and one year after vaginal prolapse surgery 2) To evaluate perioperative complications of the two procedures 3) To study the change in pelvic floor disorders symptoms in postoperative period ( 6 months and 12 months) among two groups.
2. Methods 2.1. Recruitment: Women with stage II or higher POP with involvement of apical compartment planned for surgical management will be included in the study. Detailed history will be taken regarding demographic profile like age, parity, menopausal status, mode of previous deliveries, history of smoking, heavy weight lifting. The presenting complaints as well as other associated complaints will be noted. History of previous abdominal or pelvic surgeries will be obtained. For recording the history regarding pelvic floor disorders, PFDI 20 (translated in Nepali language and pretested) will be used. General and systemic physical examination will be performed. The BMI will be noted. The prolapse will be examined and staged according to POP-Q staging system. Cough stress test and ESST will be performed to rule out SUI. The tests will be performed after reducing the prolapse to rule out occult SUI. The intended prolapse surgery as well as necessary concomitant surgeries will be decided by the surgeon. Informed written consent will be obtained from the participants for including into the trial.

2.2. Randomization: The participants will be randomized on 1:1 basis to one of the methods of vaginal apical suspension either SSLF or USLS. Computer generated randomization table will be generated and used for randomization. The patients will be randomized by one of the residents posted in unit who is not involved in the research one day prior to surgery after pre-operative examination and decision for surgery is made.

2.3 Surgical procedures The surgeries will be performed by a team of surgeons with technical competency in both the techniques.

Method of Sacrospinous Ligament Fixation (SSLF):

Women who are randomized to this group will undergo unilateral sacrospinous ligament fixation. For all the women with uterine descent requiring the hysterectomy, vaginal hysterectomy will be performed using standard method. In women with vault prolapse, the apex of the vagina is grasped with Allis forceps. A horizontal incision is given in the apex over previous scar of vaginal vault. The enterocele sac will be dissected off the vaginal mucosa. The sacrospinous ligament will be accessed via posterior approach. A vertical incision will be given in the posterior vaginal wall leaving ~2-3 cm bridge of vaginal mucosa between the incision and the vault. The right pararectal space will be entered by blunt dissection till the sacrospinous ligament is reached. The rectum will be mobilized medially. Once the ischial spine is identified, SSL is palpated by dorsal and medial movement of the fingers. Any fibroareolar tissue present over the ligament will be removed with the swab held in sponge holding forceps. Per rectal examination is performed to rule out rectal injury. For proper visualization of SSL, Breisky-Navratil retractor will be used. A permanent suture Polyster no 1 will be passed through the SSL around 1.5 to 2 cm medial to the ischial spine under direct vision with the help of long needle holder. The other end of the suture is brought out to the right end of vaginal vault and it will be tagged. Another suture will be placed in SSL medial to the previous one and again brought out to the vault towards left end and will be tagged. Anterior repair if needed will be performed. The upper portion of posterior vaginal wall mucosa will be closed. The suspension sutures are then tied so that the vagina comes in contact with the SSL without the bridge of suture in between. Posterior colpoperinorrhaphy will then be performed. If anti-incontinence procedures are needed, will also be performed.