Clinical trial NCT03663959: Intermediate-term Outcomes of Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation: A Comparative Study
Official title: Intermediate-term Outcomes of Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation: A Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation
Keywords: Outcomes
Pectopexy
Sacrospinous ligament fixation
Prolapse surgery
Lead sponsor: Kocaeli Derince Education and Research Hospital
Sponsor class: OTHER
First posted: 2018-09-10
Enrollment: 79
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women who had undergone uterovaginal or vaginal vault prolapse surgery ( vaginal sacrospinous fixation /laparoscopic pectopexy procedures ) between January 2014 and June 2018 at the H.S.U. 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.

Eligibility criteria: Inclusion Criteria:

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.

Exclusion Criteria:

Women who had surgeries for malignancy suspicion or pelvic inflammatory disease and women with pectouteropexy procedure were not included into the study.

Primary outcomes:
measure: Apical descensus relapse rate
timeFrame: 7-43 months after surgery
Secondary outcomes:
measure: Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)
timeFrame: 7-43 months after surgery
measure: Prolapse Quality of Life (P-QOL)
timeFrame: 7-43 months after surgery
measure: De novo central or lateral defect cystocele rate
timeFrame: 7-43 months after surgery
measure: De novo rectocele rate
timeFrame: 7-43 months after surgery
measure: Satisfied with surgery rate
timeFrame: 7-43 months after surgery
measure: De novo stress urinary incontinence rate
timeFrame: 7-43 months after surgery
measure: De novo urge urinary incontinence rate
timeFrame: 7-43 months after surgery
Other outcomes:
Locations:
city: Kocaeli
country: Turkey
facility: Bahar Sarıibrahim Astepe
city: Kocaeli
country: Turkey
facility: S.B.U Kocaeli Derince Education and Research Hospital
Study officials:
affiliation: H.S.U Kocaeli Derince Training and Research Hospital
name: bahar sarıibrahim astepe
role: PRINCIPAL_INVESTIGATOR
References: