Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy

Summary

The anterior vaginal wall is the segment most commonly affected by prolapse. Traditionally, anterior vaginal wall prolapse is repaired via anterior colporrhaphy (native tissue repair), which is known to have a high recurrence rate. Several factors like the suture plication method might affect the outcome of anterior colporrhaphy. The use of single button sutures for example might be associated with the high recurrence rate because the sutures might not be able to retain adequate strength. Nonetheless, no comparative data exist so far regarding the efficacy and safety of anterior colporrhaphy when analyzing the plication method of sutures (= comparison between continuous stiches versus simple interrupted stiches).

The objective of this study is to compare the of patients undergoing anterior colporrhaphy due to symptomatic POP - using either continuous stiches or simple interrupted stiches.

This is a randomized, single-center, superiority trial. Anterior colporrhaphy will be performed in a traditional standardized manner in accordance with the policy of our institution. After midline incision and preparation of vesicovaginal fascia, midline plication of the fibromuscular layer is performed. Patients are randomized either to the group receiving continuous sutures or to the group with simple interrupted stitches. The primary outcome of interest is subjective symptom improvement (evaluated by German version of the pelvic floor questionnaire) assessed at 6 and 12 months after surgery. Secondary outcome variables include anatomical outcomes, condition-specific quality of life and adverse events related to anterior colporrhaphy. Due to the power calculation, an estimated and planned number of participants is 40.

Conditions

• Cystocele
• Cystocele, Midline
• Vaginal Prolapse
• Prolaps Bladder
• Pelvic Organ Prolapse

Interventions

PROCEDURE

Anterior colporrhaphy

All patients will be operated by the vaginal route. They are prepared under strict aseptic conditions in the dorsal lithotomy position. The bladder is emptied preoperatively with a thin disposable catheter and antibiotic prophylaxis (cefazolin) is administered before incision. A vasoconstricting solution (combination of vasopression and NaCl) is administered and a vertical anterior vaginal incision is made from the apex to two centimeters short of the external urethral meatus using an electric cautery or a scalpel. The vaginal epithelium is grasped on both sides and the fibromuscular layer of the anterior vaginal wall is sharply dissected laterally to the inferior pubic ramus. The bladder is completely dissected from the apex and up to 4 to 6 cm from the pubic ramus. The anterior colporrhaphy is defined as a native tissue repair and rows of absorbable sutures (2/0 vicryl) are used.

Sponsors & Collaborators

• Medical University of Vienna

  lead OTHER

Principal Investigators

• Barbara Bodner-Adler · Medical University of Vienna, Department for Obstetrics and Gynecology

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-07-01

Primary Completion

2023-07-01

Completion

2023-07-01

Countries

• Austria

Study Locations