Clinical trial NCT05930795: Comparison of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries
Official title: Evaluation of the Comparison of Anatomical and Functional Results of Laparoscopic Pectopexy and Laparoscopic Lateral Suspension Surgeries for the Treatment of Pelvic Organ Prolapse
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patients With Pelvic Organ Prolapse
Pectopexy
Lateral Suspension
Pop-q
Pisq-12
Lead sponsor: Gaziosmanpasa Research and Education Hospital
Sponsor class: OTHER_GOV
First posted: 2023-07-05
Enrollment: 67
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: There is not a study in the literature comparing laparoscopic pectopexy and laparoscopic lateral suspension (LLS) surgeries in the surgical treatment of pelvic organ prolapse. However, there are studies comparing the efficacy of other surgery types for pelvic organ prolapse. For example,In a study, the clinical and anatomical success rate in LLS operations was 83.8%, while the success rate in abdominal sacropexy operation was 89.2%.In another study in which pectopexy and vaginal sacro spinous fixation operations were compared, apical prolapse recurrence rates were found to be similar in both groups.

Detailed description: Pelvic organ prolapse (POP) can be defined as the protrusion of the pelvic organs out of the vagina. Many women experience the symptoms of prolapse of the pelvic organs during their daily activities, during sexual intercourse or during exercise. POP causes various undesirable effects in terms of sexual life and body aesthetics in women. With the increase in the number of elderly individuals in societies, the prevalence of prolapse cases is increasing and is becoming more common.

Patients who had laparoscopic pectopexy operation due to minimum POPQ stage 2 according to the International Classification of Pelvic Organ Prolapse Quantification (POP Q) in our hospital and who had ls lateral suspension surgery with the same indication were planned to be included retrospectively. In the first group, patients who had laparoscopic pectopexy operation were planned to be included. In the second group, it was planned to include patients who had ls lateral suspension operation.

Demographic and intra operative data collected before the procedure: (operation time, estimated blood loss, hospital stay, bowel and bladder injury) and intra operative and postoperative complications and recurrence rates and anatomically preoperative and post op Pelvic prolapse (with POP-Q classification), PopQ values (minimum 6 months) were aimed to be compared between two groups to assess anatomic comparement. Furthermore, the patients will be called back and Pelvic Organ Prolapse / Incontinence Sexual Questionnaire (PİS-Q) questionnaire will be applied to both groups and the results will be compared prospectively to assess functional results.

Eligibility criteria: Inclusion Criteria:

* Patients with POP Q stage 2 and above, operated for symptomatic pelvic organ prolapse,

  * Being a Citizen of the Republic of Turkey over the age of 18
  * Patients operated by the same experienced surgeons

Exclusion Criteria:

* To have received chemotherapy and/or radiotherapy for any reason before
* Having previously operated for prolapse
* Cases with Contraindications for Laparoscopy
* Cases with severe cardiovascular or respiratory disease

Primary outcomes:
measure: Comparison of pre and post operative assessment of POP-Q measurements
timeFrame: 1 year
measure: Comparison of Pre and post operative assessment of Pelvic Organ Prolapse / Incontinence Sexual Questionnaire
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gaziosmanpasa Training and Research Hospital
Study officials:
References: