VAGINAL VAULT PROLAPSE PREVENTION: SACROSPINOUS LIGAMENT FIXATION vs  MODIFIED McCALL CULDOPLASTY. WHICH IS BETTER? PRELIMINARY DATA FROM A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL

Maria Chiara Paganotto1/2 ,MD Lucia Amadori2, MD Paolo Busacchi2,MD

1Scuola di Specializzazione in Ginecologia ed Ostetricia
Dipartimento di Scienze Mediche e Chirurgiche
Università di Bologna, Alma Mater Studiorum
Direttore: Professor Nicola Rizzo
2 Unità operativa di Ginecologia e Fisiopatologia della Riproduzione Umana, Azienda Ospedaliero-Universitaria Policlinico S.Orsola-Malpighi, Università di Bologna

Topic: Prolapse Surgery

Abstract

Aim: To compare the safety and efficacy of two methods used for the prevention of vaginal vault prolapse performed after vaginal hysterectomy in patients with advanced uterovaginal prolapse.
Materials and Methods: A randomized controlled trial begun in July 2013:overall,28 patients were recruited until now. Women undergoing vaginal hysterectomy for advanced uterovaginal prolapse were randomized using a computer program into one of two groups. Group A were subjected to a hysterectomy with a vaginal fascial prolapse correction which included modified McCall culdoplasty, while Group B underwent the same surgery with a sacrospinous ligament fixation. During the follow-up visits (mean follow-up 7,13 months), an objective and a subjective evaluation were performed.
Results: No significant difference between the two groups were observed in operative time, blood loss and postoperative pelvic pain. At follow-up visits, patients included in the group A had a higher anterior prolapse recurrence(p:0,15,NS), while there were no differences in posterior (p:0,75,NS) and vault prolapse recurrence (point C:-6cm in all patients; p:0,66,NS). No differences were observed in terms of chronic pelvic pain(p:0,66,NS). Dyspareunia was higher in patients included in the GROUP B(p:0,34,NS).
Conclusions: Our preliminary results demonstrate no significant differences between the two procedures for the prevention of vaginal vault prolapse recurrence. In terms of sexual function, Mc Call culdoplasty might be preferred in younger patients.
Tables:

Table 1: Patients’ general characteristics

 

TREATMENT GROUP

 

 

VARIABLES

GROUP A ()
Modified Mc Call culdoplasty

GROUP B
Sacrospinous ligament fixation

p-value
(Student’s T /Chi square tests)

age

61,50±6,3

64,33±6,1

NS

 

BMI (kg/m2)

26,83±3,6

23,34±2,9

NS

 

years of menopause (age)

47,82±4,8

51,27±7,7

NS

 

neonatal weight (g)

3493,75 ± 702,8

3422,22 ± 342,9

NS

 

presence of varicose veins or hernias

36,4%

 

18,2%

NS

 

presence of constipation, smoke or diabetes

36,4%

27,3%

NS

 

family history of prolapse

33,3%

60%

NS

 

*  Significant value: p ≤ 0,05

Table 2: Comparison of perioperative data


PERIOPERATIVE DATA

TREATMENT GROUP

 

 

 

VARIABLES

GROUP A
Modified Mc Call culdoplasty

GROUP B
Sacrospinous ligament fixation

p-value
(Student’s T /Chi square tests)

Postoperative pelvic pain (0-10)

3,90±2,9

4,38±2,8

NS

Blood loss (need for blood transfusions)

0%

0%

 

NS

Immediate post operative complications (urinary or wound infections)

10%

 

0%

 

NS

Intraoperative ureteral injuries

0%

0%

NS

*  Significant value: p ≤ 0,05

 

Table 3: Vaginal vault prolapse recurrence at a mean follow-up of 7.13 months

 

TREATMENT GROUP

 

VAGINAL VAULT PROLAPSE

GRUPPO A (10pz)
Modified Mc Call culdoplasty

GRUPPO B (5pz)
Sacrospinous ligament fixation

p-value
(Chi square test )

RECURRENCE
≥ II° STAGE (Pop-Q system)

1/10 (10%)

0/5 (0%)

NS

*  Significant value: p ≤ 0,05