Continuous Stitches Versus Simple Interrupted Stitches for Anterior Colporrhaphy

NCT05449054 | Unknown

• 1 other identifier: Sutures in colporrhaphy
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• subjective symptom improvement

  differences in the German version of the pelvic floor questionnaire (12 months after the operation compared to preoperative score, ranging from a minimum of 0 (better outcome) to a maximum of 2.875 (worse outcome))

  12 months

Secondary Outcomes (5)

• anatomical outcomes

  12 months

• rate of adverse events

  12 months

• operation time

  1 day

• blood loss

  1 day

• pain killers

  30 days

Study Arms (2)

Continuous stitches for anterior colporrhaphy

ACTIVE COMPARATOR

Continuous stitches will be used for plication during anterior colporrhaphy. Sutures will be at a distance of no more than 0.5 cm. Trimming of the vagina will be performed if necessary. The anterior vaginal skin is closed with continuous 2/0 vicryl sutures.

Procedure: Anterior colporrhaphy

Interrupted stitches for anterior colporrhaphy

ACTIVE COMPARATOR

Interrupted stitches will be used for plication during anterior colporrhaphy. Sutures will be at a distance of no more than 0.5 cm. Trimming of the vagina will be performed if necessary. The anterior vaginal skin is closed with continuous 2/0 vicryl sutures.

Procedure: Anterior colporrhaphy

Interventions

Anterior colporrhaphy PROCEDURE

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.

Continuous stitches for anterior colporrhaphy; Interrupted stitches for anterior colporrhaphy

Eligibility Criteria

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

You may qualify if:

• Anterior vaginal wall prolapse beyond the hymen (POPQ point Ba \>0) with a central defect.
• Vaginal bulge symptoms
• Reconstructive surgery via native tissue repair is indicated and planned.

You may not qualify if:

• Recurrent anterior vaginal wall prolapse
• Anterior vaginal wall prolaps with lateral defect
• Reconstructive surgery using mesh or obliterative surgery is planned
• Known pelvic malignancy
• Current systemic glucocorticoid or immunosuppressant treatment
• Subject is unable or unwilling to participate

Sponsors & Collaborators

• Medical University of Vienna: lead

Study Sites (1)

Medical University of Vienna, Department of Obstetrics and Gynecology

Vienna, 1090, Austria

RECRUITING

MeSH Terms

Conditions

Cystocele; Uterine Prolapse; Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Genital Diseases

Study Officials

• Barbara Bodner-Adler

  Medical University of Vienna, Department for Obstetrics and Gynecology

  STUDY CHAIR

Central Study Contacts

Christine Bekos

CONTACT

0043 69913536030; christine.bekos@meduniwien.ac.at

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principan Investigator

Study Record Dates

• First Submitted: June 9, 2022
• First Posted: July 8, 2022
• Study Start: July 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2023
• Last Updated: July 8, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)