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

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ClinicalTrials.gov Identifier: NCT03663959
Recruitment Status : Completed
First Posted : September 10, 2018
Last Update Posted : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
bahar sarıibrahim astepe, 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.

Condition or disease Intervention/treatment
Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation Procedure: vaginal sacrospinous fixation procedure with dr.Aksakal's desta suture carrier Procedure: Laparoscopic Pectocolpopexy procedure

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.

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Study Type : Observational
Actual Enrollment : 79 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intermediate-term Outcomes of Laparoscopic Pectopexy and Vaginal Sacrospinous Fixation: A Comparative Study
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : December 30, 2018
Actual Study Completion Date : December 30, 2018

Group/Cohort Intervention/treatment
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.
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 Pectopexy Group
Women who had Laparoscopic Pectopexy procedure in our clinic between January 2014 and June 2018
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.




Primary Outcome Measures :
  1. Apical descensus relapse rate [ Time Frame: 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 :
  1. Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) [ Time Frame: 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.

  2. Prolapse Quality of Life (P-QOL) [ Time Frame: 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.

  3. De novo central or lateral defect cystocele rate [ Time Frame: 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

  4. De novo rectocele rate [ Time Frame: 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

  5. Satisfied with surgery rate [ Time Frame: 7-43 months after surgery ]
    The ratio of women satisfied with surgery to all women

  6. De novo stress urinary incontinence rate [ Time Frame: 7-43 months after surgery ]
    The ratio of women with de novo stress urinary incontinence to all women

  7. De novo urge urinary incontinence rate [ Time Frame: 7-43 months after surgery ]
    The ratio of women with de novo urge urinary incontinence to all women



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
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.
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03663959


Locations
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Turkey
Bahar Sarıibrahim Astepe
Kocaeli, Turkey, 41100
S.B.U Kocaeli Derince Education and Research Hospital
Kocaeli, Turkey, 41100
Sponsors and Collaborators
Kocaeli Derince Education and Research Hospital
Investigators
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Principal Investigator: bahar sarıibrahim astepe H.S.U Kocaeli Derince Training and Research Hospital
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Responsible Party: bahar sarıibrahim astepe, obstetrics and gynecology specialist, Kocaeli Derince Education and Research Hospital
ClinicalTrials.gov Identifier: NCT03663959    
Other Study ID Numbers: KOCAELİe-14101
First Posted: September 10, 2018    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The investigators do not prefer to share the study plan and records.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by bahar sarıibrahim astepe, Kocaeli Derince Education and Research Hospital:
Outcomes
Pectopexy
Sacrospinous ligament fixation
Prolapse surgery