Prospective Study for Vaginal Vault Prolapse After Hysterectomy: Comparison of Two Surgical Methods

NCT02290288 | Completed

• 1 other identifier: VGFOUREG-28601
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

Brief Summary

The study is carried out at the Sahlgrenska University Hospital and the patient population consists of women referred with symptomatic and bothersome post-hysterectomy vaginal vault prolapse at least 1 cm above or beyond the hymeneal remnants. The interventions are either vaginal sacrospinousfixation or laparoscopic sacrocolpopexy following randomization to one of the types of surgery. The primary outcome is anatomical failure based on clinical assessment. Failure is defined clinically, according to the Pelvic Organ Prolapse Quantification system, as Ba, C or Bp at the hymen or below on maximum Valsalva maneuver one and two years after the surgery. Secondary outcomes are evaluation of continence, sexual function and prolapse symptoms based on validated questionnaires 1, 2, 5 and 10 years after the surgery.

Conditions

Vaginal Vault Prolapse

Outcome Measures

Primary Outcomes (1)

• anatomical failure (Failure was defined clinically as Ba, C or Bp at the hymen or below, on maximum Valsalva maneuver.)

  The primary outcome measure was anatomical failure based on clinical assessment. Failure was defined clinically as Ba, C or Bp at the hymen or below, on maximum Valsalva maneuver.

  1 year

Secondary Outcomes (4)

• continence status

  1 and 5 years

• sexual function

  1 and 5 years

• prolapse symptoms

  1 and 5 years

• quality of life

  1 and 5 years

Study Arms (2)

SSF

ACTIVE COMPARATOR

1\. vaginal surgery arm (SSF)

Procedure: vaginal surgery

LSC

ACTIVE COMPARATOR

laparoscopic surgery arm (LSC)

Procedure: laparoscopic surgery

Interventions

vaginal surgery PROCEDURE

SSF

laparoscopic surgery PROCEDURE

LSC

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• post-hysterectomy patients with at least two-compartment prolapse (with affected apical/vault compartment,
• stage II or higher on the Pelvic Organ Prolapse Quantification system (POP-Q)),
• suffering from symptoms of prolapse,
• requesting pelvic floor reconstructive surgery, and
• diagnosed with a vault prolapse.

You may not qualify if:

• patients with prolapse and uterus in place,
• those not requesting pelvic floor surgery,
• patients who do not understand Swedish or are not capable to fulfill follow up procedure

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Dept of Obst Gyn, Sahlgrenska University Hospital

Gothenburg, VGR, 41381, Sweden

Location

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Laparoscopy

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: senior consultant

Study Record Dates

• First Submitted: November 4, 2014
• First Posted: November 14, 2014
• Study Start: October 1, 2005
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

SE (1)