Intermediate-term Outcomes of Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation: A Comparative Study
- Conditions
- Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation
- Interventions
- Procedure: Laparoscopic Pectocolpopexy procedureProcedure: vaginal sacrospinous fixation procedure with dr.Aksakal's desta suture carrier
- Registration Number
- NCT03663959
- Lead Sponsor
- Kocaeli Derince Education and Research Hospital
- Brief Summary
Forty-three women who had vaginal sacrospinous fixations using Dr. Aksakal's Desta suture carrier and 36 women who had laparoscopic pectopexies between January 2014 and June 2018 at H.S.U Kocaeli Derince Training and Research Hospital Gynecology and Obstetrics clinic were re-examined between 15 June and 30 December 2018 gynecologically.
- Detailed Description
Forty-three women who had vaginal sacrospinous fixations using Dr. Aksakal's Desta suture carrier and 36 women who had laparoscopic pectocolpopexies were re-examined 7 to 43 months after surgery. All of the women had undergone surgery for stage 2 or greater uterovaginal or vaginal vault prolapse according to the Pelvic Organ Prolapse Quantification (POP-Q) system.
All of the patients received telephone calls and were invited for a gynecological re-examination. All but one patient in the vaginal surgery group came in for a gynecological control. We conducted a phone interview with the one patient not agreeing to come to the control, and we learned that she had a relapse 6 months after the operation. She underwent another prolapse surgery at a different hospital. She described her postsurgical complaints, and we noted that she was unsatisfied with the surgery. In the postoperative re-evaluation between 15 June and 30 December 2018, all of the women were examined in the lithotomy position for apical, anterior, and posterior compartment descensus. Stage 2 or greater apical descensus or a cystocele or rectocele according to the POP-Q system were accepted as postoperative relapses. All of the patients answered the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) and Prolapse Quality of Life (P-QOL) questionnaire. All of the women were asked about de novo urge urinary incontinence and de novo stress urinary incontinence. In addition, each patient's satisfaction with the surgery was asked and recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 79
Those patients with stage 2 or greater uterovaginal/vaginal cuff prolapses according to the POP-Q system underwented to surgery (vaginally or laparoscopically) between January 2014 and June 2018 were included to the study.
Women who had surgeries for malignancy suspicion or pelvic inflammatory disease and women with pectouteropexy procedure were not included into the study.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Laparoscopic Pectopexy Group Laparoscopic Pectocolpopexy procedure Women who had Laparoscopic Pectopexy procedure in our clinic between January 2014 and June 2018 Vaginal Sacrospinous Fixation group vaginal sacrospinous fixation procedure with dr.Aksakal's desta suture carrier Women who had vaginal sacrospinous fixation procedure with Dr.Aksakal's Desta suture carrier in our clinic between January 2014 and June 2018.
- Primary Outcome Measures
Name Time Method Apical descensus relapse rate 7-43 months after surgery The ratio of women with stage 2 or greater vaginal cuff prolapsus according to the Pelvic Organ Prolapse Quantification (POP-Q) system to all women
- Secondary Outcome Measures
Name Time Method Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) 7-43 months after surgery The PISQ-12 is a self-adminestered questionnaire that evaluates sexual function of women with pelvic organ prolapse or urinary incontinence. The questionnaire has 12 items. Other than the first 4 questions that are scored from 4 to 0, all questions are scored from 0 to 4. The total score is calculated with totaling the score of each question. The maximum score is 48. Higher scores show good sexual functioning of women.
Prolapse Quality of Life (P-QOL) 7-43 months after surgery The P-QOL questionnaire evaluates the impact of urogenital prolapsus on quality of life in women. The questionnaire has nine items, each of has 4-point scoring system and a total score of 0-100. A high total score indicates worsening of quality of life of women with pelvic organ prolapsus.
Satisfied with surgery rate 7-43 months after surgery The ratio of women satisfied with surgery to all women
De novo central or lateral defect cystocele rate 7-43 months after surgery The ratio of women with stage 2 or greater central or lateral defect cystocele according to the Pelvic Organ Prolapse Quantification (POP-Q) system to all women
De novo rectocele rate 7-43 months after surgery The ratio of women with stage 2 or greater rectocele according to the Pelvic Organ Prolapse Quantification (POP-Q) system to all women
De novo stress urinary incontinence rate 7-43 months after surgery The ratio of women with de novo stress urinary incontinence to all women
De novo urge urinary incontinence rate 7-43 months after surgery The ratio of women with de novo urge urinary incontinence to all women
Trial Locations
- Locations (2)
S.B.U Kocaeli Derince Education and Research Hospital
🇹🇷Kocaeli, Turkey
Bahar Sarıibrahim Astepe
🇹🇷Kocaeli, Turkey