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Intermediate-term Outcomes of Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation: A Comparative Study

Intermediate-term Outcomes of Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation: A Comparative Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03663959
Enrollment
79
Registered
2018-09-10
Start date
2018-06-15
Completion date
2018-12-30
Last updated
2019-01-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation

Keywords

Outcomes, Pectopexy, Sacrospinous ligament fixation, Prolapse surgery

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.

Interventions

PROCEDUREvaginal sacrospinous fixation procedure with dr.Aksakal's desta suture carrier

A right sacrospinous fixation using Dr. Aksakal's Desta suture carrier with two permanent sutures that combined the sacrospinous ligament and vaginal cuff fascia was done. The Desta suture carrier was developed for deep pelvic surgery, and the suture depth can be easily adjusted. After the vaginal hysterectomy, under the vaginal cuff mucosa, we created a tunnel through the spinous process with a straight tool. After passing the rectovaginal pillars, the perirectal space was entered and the ischial spine was palpated. With the help of an index finger placed on the spinous process, we placed two permanent sutures 1.5-2 cm medial to the spinous process on the sacrospinous ligament and iliococcygeus muscle complex using the Desta suture carrier. Next, permanent sutures were combined with the pubocervicovaginal and rectovaginal fascia under the vaginal cuff mucosa.

PROCEDURELaparoscopic Pectocolpopexy procedure

First, the peritoneal layer above and lateral to the bladder was opened parallel to the round ligament toward the pelvic side wall on the right side. Then, with the guidance of the obliterated umbilical artery, lateral to the obliterated umbilical artery and medial to the external iliac vein, the iliopectineal ligament was found . At this point, a segment of approximately 3-4 cm2 was formed, exposing the iliopectineal (Cooper's) ligament. In this area, behind the obliterated umbilical artery, the obturator nerve could be seen, and special care was given not to make contact with the nerve. The same area on the left side was prepared using the same steps. Then, anterior part of the vaginal cuff was prepared for mesh fixation. Bilaterally, the ends of a polypropylene monofilament mesh (1,5x15 cm) were fixed to the iliopectineal ligament with nonabsorbable polypropylene or polyester sutures . The vaginal cuff was elevated to POP-Q level 0-1.

Sponsors

Kocaeli Derince Education and Research Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
45 Years to 81 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
Apical descensus relapse rate7-43 months after surgeryThe 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

MeasureTime frameDescription
Prolapse Quality of Life (P-QOL)7-43 months after surgeryThe 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.
De novo central or lateral defect cystocele rate7-43 months after surgeryThe 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 rate7-43 months after surgeryThe ratio of women with stage 2 or greater rectocele according to the Pelvic Organ Prolapse Quantification (POP-Q) system to all women
Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)7-43 months after surgeryThe 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.
De novo stress urinary incontinence rate7-43 months after surgeryThe ratio of women with de novo stress urinary incontinence to all women
De novo urge urinary incontinence rate7-43 months after surgeryThe ratio of women with de novo urge urinary incontinence to all women
Satisfied with surgery rate7-43 months after surgeryThe ratio of women satisfied with surgery to all women

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026