Health Condition 1: N813- Complete uterovaginal prolapse
Conditions
Interventions
Intervention1: laparoscopic pectopexy: compare laparoscopic pectopexy with the standard laparoscopic sacropexy in women with symptomatic apical prolapse (POP-Q stage II).
Control Intervention1: lapar
Sponsors
All India Institute Of Medical Sciences Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women with symptomatic apical prolapse (uterovaginal prolapse or vaginal vault prolapse) of stage 2 or greater according to the Pelvic Organ Prolapse Quantification (POP-Q) system. 2. Women who agree to participate in the trial and to comply with the protocol and give their written consent for the same. 3. Patients who are able to communicate by telephone and answer questions. 4. Adequate cardio respiratory, renal and liver functions and who will be fit to undergo surgery.
Exclusion criteria
Exclusion criteria: Prior surgeries for vaginal prolapse correction 2. Active pelvic inflammatory disease 3. Current pregnancy 4. Any contraindications against one of the surgical methods applied in the study, hence making the randomization impossible (e.g. previously identified or strongly suspected massive adhesions between sigmoid colon and presacral peritoneum. 5. History of premalignant or malignant diseases of uterus, cervix or adnexa 6. Any contraindication for laparoscopic surgery 7. Patient unfit for anaesthesia 8. Patient not willing to comply with the protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Average placement of mesh timeTimepoint: 1 year 6 month | — |
Secondary
| Measure | Time frame |
|---|---|
| operation time, blood loss, occurrence of major complications. Hemoglobin decline, Pain (VAS score), duration of hospital stay, onset of bowel movements, episodes of constipation, urinary retention or urgency, de novo urinary incontinence (urge or stress urinary incontinence), urinary tract infections, occurrence of de novo anterior and lateral defect, de novo cystocele, de novo rectocele, dyspareunia, mesh erosion, relapse of apical prolapse and satisfaction rate. Timepoint: 1 year 6 month | — |
Countries
India
Contacts
Public ContactDr Kanhu Charan Dash
AIIMS RISHIKESH
Outcome results
None listed