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

NCT ID: NCT03663959

Last Updated: 2019-01-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 79 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2018-12-30

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.

Conditions

Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Vaginal Sacrospinous Fixation group

Women who had vaginal sacrospinous fixation procedure with Dr.Aksakal's Desta suture carrier in our clinic between January 2014 and June 2018.

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

Intervention Type: PROCEDURE

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 Pectopexy Group

Women who had Laparoscopic Pectopexy procedure in our clinic between January 2014 and June 2018

Laparoscopic Pectocolpopexy procedure

Intervention Type: 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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: PROCEDURE

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Kocaeli Derince Education and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

bahar sarıibrahim astepe

obstetrics and gynecology specialist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

bahar sarıibrahim astepe

Role: PRINCIPAL_INVESTIGATOR

H.S.U Kocaeli Derince Training and Research Hospital

Locations

Bahar Sarıibrahim Astepe

Kocaeli, , Turkey (Türkiye)

S.B.U Kocaeli Derince Education and Research Hospital

Kocaeli, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

KOCAELİe-14101

Identifier Type: -

Identifier Source: org_study_id