Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy

Pelvic Organ Prolapse Clinical Trial

Official title:

Nonabsorbable Versus Absorbable Sutures for Anterior Colporrhaphy: a Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03736811
• Other study ID #: SNUH-1810-037-977
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 8, 2018
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2022
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this is to compare surgical outcomes of anterior colporrhaphy using nonabsorbable sutures with anterior colporrhaphy using absorbable sutures.

Description:

This trial is a prospective, randomized trial conducted with the aim to determine superiority of anterior colporrhaphy using nonabsorbable sutures over absorbable sutures with regard to the primary outcome. Participants will undergo reconstructive surgery for prolapse, including anterior colporrhaphy using the assigned suture materials under general or spinal anesthesia. The anterior colporrhaphy will be performed in a traditional manner with midline plication of the fibromuscular layer using either 2-0 nonabsorbable (polyester or polypropylene; Ethicon, Somerville, NJ) or absorbable (polyglactin 910 or polydioxanone; Ethicon) sutures. Concomitant procedures will be performed as intended prior to surgery. Women with a uterus in situ will undergo hysterectomy and all women will receive an apical suspension procedure, including uterosacral ligament suspension, sacrospinous ligament fixation, and iliococcygeal suspension, according to the preference of surgeon. Posterior colporrhaphy and incontinence surgery will also be performed, if indicated (i.e. women with Bp ≥-1 or documented urodynamic stress incontinence).

Enrollment, treatment and data collection will be standardized by all sites. The study will be a single-blind study, as it is impossible to blind the study surgeon for the surgical procedure to which the subject in assigned. However, all outcomes assessors and the subjects will be blinded to the treatment assignment. Postoperative follow-up will take place after 5 weeks, 6 months and 12 months. Patients will undergo a standard gynecological examination including POPQ and fill in questionnaires.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 196
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years and older

Eligibility

Inclusion Criteria:

• Anterior vaginal descent beyond the hymen (i.e. POPQ Ba>0)

• Vaginal bulge symptoms (i.e. an affirmative response to the question 3 from the PFDI-20)

• Reconstructive surgery is planned

Exclusion Criteria:

• Recurrent anterior vaginal wall prolapse

• Reconstructive surgery using mesh or obliterative surgery for prolapse is planned

• Known pelvic malignancy

• Systemic glucocorticoid or immunosuppressant treatment

• Subject wishes to retain her uterus

• Subject is unable and unwilling to participate in

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Device:
• Polyglactin 910 or polydioxanone
Vicryl or PDS II
• Polyester or polypropylene
Ethibond Excel or prolene

Locations

Country	Name	City	State
Korea, Republic of	Myung Jae, Jeon	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical success	defined as the absence of all of the following: (1) anterior vaginal descent beyond the hymen (POPQ point Ba>0); (2) presence of vaginal bulge symptoms (affirmative response to the question 3 from the Pelvic Floor Distress Inventory-20 ("do you usually have a bulge or something falling out that you can see or feel in your vaginal area?"; (3) re-treatment for recurrent anterior vaginal wall prolapse by either surgery or pessary.	One year after surgery
Secondary	The rate of anterior vaginal descent beyond the hymen	POPQ point Ba>0	One year after surgery
Secondary	The rate of vaginal bulge symptoms	an affirmative response to the question 3 from PFDI-20	One year after surgery
Secondary	The rate of re-treatment for recurrent anterior vaginal wall prolapse	by either surgery or pessary	One year after surgery
Secondary	The rate of suboptimal anatomical outcome in each compartment	POPQ point Ba, C, or Bp =-1	One year after surgery
Secondary	Change of POPQ values	point Ba, C, Bp and TVL	From baseline to 1 year after surgery
Secondary	Change of PFDI-20 scores	The PFDI-20 is a valid and reliable condition-specific quality-of-life questionnaires for women with pelvic floor disorders. It has 20 items and 3 scales (Pelvic Organ Prolapse Distress Inventory, Colorectal-Anal Distress Inventory and Urinary Distress Inventory). Each scale is scored from 0 to 100; higher scores indicate greater symptom burden.; The PFDI-20 total score is obtained by adding the scores from the 3 scale scores together (0-300).	From baseline to 1 year after surgery
Secondary	The rate of adverse events related with anterior colporrhaphy	intraoperative- bladder injury, ureteral obstruction, massive bleeding; postoperative- hematoma, vesico-vaginal fistula, ureteral obstruction, urinary tract infection, incomplete bladder emptying, overactive bladder or stress incontinence symptoms, suture erosion, vaginal wound dehiscence, infection or granulation tissue, etc.	From baseline to 1 year after surgery