A DOUBLE-BLIND, NON-INFERIORITYRANDOMIZED CONTROLLED TRIAL OF TRANSVAGINAL PROCEDURES FOR THE REPAIROF A RECTOCELE
E. W. HENN1, B. W.RICHTER 1, D. A. BURGER 2;
1Dept.Obstetrics & Gynaecology, Bloemfontein, South Africa, 2DepartmentStatistics, Dept. Obstetrics & Gynaecology, Bloemfontein, SouthAfrica.
Introduction: Posteriorcompartment prolapse is a prevalent condition. It is mostly due to arectocele and is often accompanied by defecatory disorders. A largenumber of surgical procedures have been described to correct arectocele and these are in part a reflection of the philosophicalapproaches towards correcting a rectocele. The defect-specificposterior repair (DSR) has been used universally by gynecologists tocorrect the vaginal bulge with good reported outcomes. Colorectalsurgeons on the other hand prefer to correct the rectal disorder bymeans of transanal or abdominal procedures. There are very fewrandomized trials to assess these procedures.
Objective: Torandomly evaluate a DSR in comparison to a rectocele plication repair(RPR) in regards to objective and subjective outcomes after 1year.
Methods: A non-inferiority randomized trial designwas used and participants who required a surgical repair of arectocele were enrolled to either a RPR or a DSR after consenting.Inclusion criteria were isolated posterior compartment disorders andno previous mesh-based pelvic procedures. A non-inferiority margin of15% was identified, based on the reviewed literature which resultedin a sample size of at least 50 patients. A pragmatic approach wasfollowed in regards to participant assessment and follow-up due tolimited healthcare resources. Validated instruments and methodologieswere used in the structured follow-up visits. Assessors andparticipants were blinded to the allocated treatment. A standardizedDSR procedure was followed. The RPR is a vaginal procedure whichcorrects the anterior rectal wall defect similar to those of thetransanal procedures. Data were analyzed and reported on after 12months of follow-up.
Results: Between December 2014 toDecember 2015, 62 women were assessed for eligibility and 7 wereexcluded (5 did not meet inclusion criteria and 2 declined toparticipate). 27 Participants were randomized to DSR and 28 to RPR.The mean age was 60 years, mean BMI was 30.84 kg/m2 andthe mean parity was 3. There was no significant difference in thedemographics between the two groups. After the 3-month follow-upvisit, 2 of the RPR and 1 of the DSR participants were lost tofollow-up. The 12 month follow-up was completed by 26 participants ineach group. There was no difference in operative parameters orcomplications. The RPR participants reported more pain (mean score3.3 vs 1.7) on day 1 after surgery (p=0.0001). Anatomic success waspresent in 20 (76.9%) participants in the DSR group and in 24 (92.3%)of those in the RPR group (p=0.2485, 95% CI -13.6;42.5). Symptomaticimprovement was significantly more pronounced in the RPR group forawareness of a vaginal bulge (p=0.0226), obstructed voiding(p=0.0238) and overactive bladder (dry) (p=0.0266). Quality of lifeoutcomes were furthermore significantly greater among the RPRparticipants in regard to the questionnaire scores of the PFDI-20(p=0.0160) and the PFIQ-7 (p=0.0041). There was no difference in thePISQ-12 questionnaire scores or in reported sexual function betweenthe two groups and no occurrences of de novodyspareunia.
Conclusions: The rectocele plication procedurewas objectively not inferior to a defect-specific posterior repairfor women with a rectocele 1 year after surgery. There was howeversignificant differences in the subjective outcomes which favored arectocele plication. This procedure can be offered to women withsymptomatic rectoceles to correct the anatomic defect and improvetheir quality of life.
Table1: Objective assessments at baseline and at 12 months follow-up
Table2: Subjective outcomes at baseline and after 12 months
Obstrdefecation (12 months)
Obstrvoiding (12 months)