Hiatal reduction with the 'puborectalis sling': A multicentre randomised controlled trial.

Abstract

Introduction: Female pelvic organ prolapse is a common condition that may be regarded as a hernia through the levator hiatus. Both prolapse and recurrence after prolapse surgery seem associated with the size of this hernial portal. Reducing its size may reduce recurrence risk, and this may be achieved through the 'puborectalis sling. (PR Sling). We report medium- term results of a multicentre randomised controlled trial investigating this procedure. Method(s): Women undergoing prolapse repair at the discretion of the surgeon with a pre-operative hiatal area on Valsalva of >= 30cm2, were recruited to a prospective multicentre RCT which compared POP surgery alone or POP surgery with PR sling. Primary outcome was prolapse recurrence on POPQ and ultrasound at 2 years. The PR sling was inserted after completion of prolapse repair, via bilateral groin and perianal incisions of 2 cm in length. A tunnel was created digitally below the anococcygeal raphe, connecting the two perianal incisions. A 3cm x 25 cm strip of polypropylene mesh (Johnson & Johnson/Ethicon, Somerville NJ), was passed through this tunnel with the help of an angled clamp. A curved Stamey needle (90 degree curvature) was inserted through the obturator foramen to exit in the ipsilateral perianal incision, allowing retrieval of the mesh sling. Needle insertion was performed under digital guidance (vaginal and rectal). The mesh was secured to the periosteum of the inferior pubic rami using absorbable sutures. Follow-up included questionnaires, POPQ and translabial 4D ultrasound. Result(s): 221 women consented to participate in the trial and 200 were randomised;109 for the intervention and 91 for the control group. Mean age at operation was 58 (27-83). Mean body mass index was 29 (15-48). 94 (47%) had a previous hysterectomy, 58 (29%) a previous incontinence or prolapse procedure. On baseline examination, mean Ba was 1.1 (-3 to +8), mean C was -0.8 (-8 to +8), mean Bp was 0 (-3 to +7). Mean Gh+Pb was 9.4 (range, 6-15). On imaging, 133 (67%) had an avulsion which was bilateral in 66 (33%). The hiatal area on Valsalva was 42.1 (range, 30-68) cm2. There were 14 significant perioperative complications, four leading to a return to theatre: one compartment syndrome of the thigh, one rectal perforation requiring PRS removal, one worsened obstructed defecation requiring PRS release, one PRS release for chronic pain. Table: Symptoms and signs at mean follow-up of 1.9 years. *X2 test, ** 2-tailed t-test. #Bladder descent to >10 mm below, uterus to <15 above, rectum to >15 mm below the symphysis. 192 patients were evaluated at least once post-operatively, with 181 having 4D translabial ultrasound. At 1.9 (range, 0.1-6.7) years, there was an average reduction of 9 cm2 (range 32.6 to -13.8) cm2 reduction in hiatal area from a mean pre-operative hiatal area of 42.1 (30 - 68.1) cm2. 56/ 192 (29%) were aware of a vaginal lump/ bulge, 150/192 (78%) had clinical prolapse recurrence, with 38/192 (20%) beyond the hymen. Sonographic prolapse recurrence was seen in 84/ 183 (46%). Table 1 shows postoperative results (ITT analysis). Conclusion(s):While there were no significant differences for satisfaction, symptoms of prolapse and POPQ findings at an average follow-up of 1.9 years, we found a lower rate of anal incontinence in women after PRS. Bladder and rectal descent on imaging as well as prolapse on ultrasound was reduced, the latter highly significantly. Reduction of hiatal area on Valsalva was much more pronounced after PRS, onfirming published observational data.