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

Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03663959
• Other study ID #: KOCAELIe-14101
• Status: Completed
• Start date: June 15, 2018
• Est. completion date: December 30, 2018

Study information

• Verified date: January 2019
• Source: Kocaeli Derince Education and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: December 30, 2018
• Est. primary completion date: December 30, 2018
• Gender: Female
• Age group: 45 Years to 81 Years

Eligibility

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.

Related Conditions & MeSH terms

• Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation

Intervention

Procedure:
• vaginal 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.
• Laparoscopic 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.

Locations

Country	Name	City	State
Turkey	Bahar Sariibrahim Astepe	Kocaeli
Turkey	S.B.U Kocaeli Derince Education and Research Hospital	Kocaeli

Sponsors (1)

Lead Sponsor	Collaborator
Kocaeli Derince Education and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Apical descensus relapse rate	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	7-43 months after surgery
Secondary	Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12)	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.	7-43 months after surgery
Secondary	Prolapse Quality of Life (P-QOL)	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.	7-43 months after surgery
Secondary	De novo central or lateral defect cystocele rate	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	7-43 months after surgery
Secondary	De novo rectocele rate	The ratio of women with stage 2 or greater rectocele according to the Pelvic Organ Prolapse Quantification (POP-Q) system to all women	7-43 months after surgery
Secondary	Satisfied with surgery rate	The ratio of women satisfied with surgery to all women	7-43 months after surgery
Secondary	De novo stress urinary incontinence rate	The ratio of women with de novo stress urinary incontinence to all women	7-43 months after surgery
Secondary	De novo urge urinary incontinence rate	The ratio of women with de novo urge urinary incontinence to all women	7-43 months after surgery