Randomised controlled clinical trial comparing the clinical outcome of autologus fascia lata to synthetic mesh for abdominal sacrocolpopexy among successfully repaired vault prolapse patients

Abstract

INTRODUCTION: Vaginal vault prolapse has been defined by the International Continence Society as descent of the vaginal cuff below a point that is 2 cm less than the total vaginal length above the plane of the hymen. Coexisting pelvic floor defects like cystocoele, rectocele or enterocele may be present in 72% of patients with vault prolapse. Pelvic organ prolapse has negative impact on quality of life of these women due to associated urinary, faecal and coital dysfunction. It is important to assess the defects of the different vaginal compartment and counsel these women before planning surgical management. A clear understanding of the supporting mechanisms of the uterus and the vagina are important in order to make the right choice of the corrective procedure and also to minimise the risk of occurrence of vault prolapse. SCOPE OF THE STUDY: Management of vaginal vault prolapse may be complex and surgical reconstruction can be challenging. The most appropriate operative procedure and approach should be selected to achieve an optimal result for the patient with vaginal vault prolapse. In the literature, several vaginal and abdominal procedures have been described to treat vault prolapsed and there is no consensus on the most effective approach or technique. Evidence shows that abdominal repair yields better long terms results with reduced incidence of recurrence. Sacrocolpopexy is a valid technique to treat apical and anterior vaginal wall prolapse. Abdominal sacrocolpopexy using synthetic mesh has proven its worth overtime. METHODOLOGY: Study Design: It is a prospective, single blinded, randomised controlled clinical trial. Sample Setting: It is a single blinded randomised controlled clinical trial (RCT) performed to compare the clinical outcome of autologous fascia lata over synthetic mesh in successfully repaired cases of vault prolapse by abdominal sacrocolpopexy. The study was conducted in the department of Urogynaecology, Institute of Social Obstetrics and Government Kasturba Gandhi Hospital for Women and Children, Madras Medical College, a tertiary care Hospital in Chennai, India. The study group comprised predominantly patients belonging to the low socio-economic status. The study population was mostly the referral patients with clinical evidence of vaginal vault prolapse. Duration of the Study: The study was conducted from April 2009 to March 2012. Sample: 58 Vaginal vault prolapse patients (N=58) were included in this study. Out of this 28underwent abdominal sacrocolpopexy with autologous Fascia Lata and 30 with Synthetic Mesh. Inclusion Criteria: Women with stage 3 to stage 4 vaginal vault prolapse (primary) or recurrent vaginal vault prolapse scheduled for abdominal sacrocolpopexy were included. Exclusion criteria: 1. Stage 1 to 2 vault prolapse. 2. Vaginal vault prolapse with abnormal pap smear. 3. Comorbid medical diseases like valvular heart disease, ischaemic heart disease, chronic obstructive pulmonary disease, renal / liver disease and central nervous system disorders. 4. BMI more than 30. SUMMARY AND CONCLUSIONS: Blood loss, duration of surgery & hospital stay did not differ significantly in the two groups. ANATOMICAL SUCCESS: Amongst the successfully repaired patients using autologus fascia lata, objective anatomical success rates were superior with reference to POP Q points Aa, Ba, Ap, Bp compared to synthetic mesh. However the anatomical outcome of C point in fascia lata group was comparable to that of mesh group. FUNCTIONAL SUCCESS: In the current study post operative resolution of lower urinary tract symptoms was equal in both fascia lata and synthetic mesh group. URINARY SYMPTOMS: None in the fascialata group developed UTI however3.6% in synthetic mesh group developed urinary tract infection in the postoperative follow up. Combining Burch colposuspension along with ASCP for patients who had coexisting SUI (overt and occult) and vault prolapse has relieved SUI in both groups. The number of participants who developed denovo SUI was 10.7% in fascia lata group and 3.3% in mesh group. None developed denovo urgency and urge urinary incontinence were same in both groups. BOWEL SYMPTOMS: Complete resolution of all pre operative bowel symptoms occurred in the autologous fascia lata group incontrast to the mesh group where 3% reported faecal urgency in the postoperative follow up. SEXUAL SYMPTOM: With fascia lata suspension, none developed de novo dyspareunia unlike mesh suspension. Nevertheless in the synthetic mesh group none developed mesh exposure / extrusion or infection post operatively. In the fasci lata group, there was no significant postoperative morbidity like haematoma infection and muscle herniation from the harvested site. The current study has revealed that vault prolapse repair by abdominal sacrocolpopexy using autologous fascia lata has comparable anatomical success to synthetic mesh. The functional outcome (clinical success) was better with autologous fascia lata suspension compared to mesh suspension. • This study highlights that autologous fascia lata is a versatile graft with comparable efficacy to mesh. Offers good and durable mechanical support of the vaginal vault. In future, larger and prospective, randomized clinical trials and a long-term follow-up are needed to further evaluate durability, anatomical outcomes and patient satisfaction after ASC with autologous fascia lata. RECOMMENDATIONS: Autologous Fascia lata is strong, pliable and homologous tissue does not involve foreign body reaction or infection. After repetitive notifications of FDA about nonuse of mesh in pelvic floor surgeries, there is increasing scope of biological grafts in reconstructive surgeries. According to this study, autologous fascia lata compares favorably in efficacy to monofilament, polyprophylene mesh and it is not associated with any significant morbidity. Follow up in our series of patients is adequate to assess accurately treatment efficacy, harvest site morbidity and patient satisfaction. There had been good medium term followup results in our study and patient satisfaction with the procedure is high. The successfully operated patients who were completely asymptomatic (in both groups) reported high patient satisfaction rate. The following advantages of autologus fascia lata has been proved in this study: • It is a scientific proven operation which is independent of synthetic graft and is devoid of mesh related problems and other surgery related complications like infection, extrusion, chronic vaginal pain, constipation and dyspareunea. • Because of minimal complications , abdominal sacro colpopexy using fascia lata can be offered to patients who hail from remote villages with no access for followup. • Autologous graft is readily available with the patient and the patient is not dependant on any commercial material for suspension. The anatomical and functional outcomes of autologus fascia lata are equivalent to that of synthetic mesh in abdominal sacrocolpopexy for management of vault prolapse, Hence abdominal sacral colpopexy using autologous fascia lata may be considered primarily for women with vaginal vault prolapsed