Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Sacral Colpopexy for Severe Pelvic Organ Prolapse

NCT03427606 | Unknown DMC

• 1 other identifier: LSCContinua
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using a continuous locked suture vs. conventional single 5-points suture for anterior mesh fixation.

Conditions

Pelvic Organ Prolapse

Keywords

sacral colpopexy; laparoscopy; mesh fixation

Outcome Measures

Primary Outcomes (1)

• Operative Time

  Operative time for LPS subtotal hysterectomy and sacral colpopexy operative time will be calculated from the entrance in the abdominal cavity.

  through study completion, an average of 1 year

Secondary Outcomes (1)

• Recurrent Prolapse

  through study completion, an average of 1 year

Study Arms (2)

Continuous Suture

EXPERIMENTAL

Procedure: Continuous Locked Suture vs Traditional 5-points suture for Laparoscopic Sacral Colpopexy

Single 5-points Suture

ACTIVE COMPARATOR

Procedure: Continuous Locked Suture vs Traditional 5-points suture for Laparoscopic Sacral Colpopexy

Interventions

Continuous Locked Suture vs Traditional 5-points suture for Laparoscopic Sacral Colpopexy PROCEDURE

To verify if the operative time of a standard laparoscopic sacral colpopexy associated to subtotal hysterectomy for the treatment of POP could be further reduced using continuous locked suture vs traditional 5-points suture for mesh fixation

Continuous Suture; Single 5-points Suture

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For patients
• Age ≤ 80 years
• Patient's informed consent
• American Society of Anesthesiologists: \< class III or IV
• Physiologic, surgical or iatrogenic menopause.
• No previous major abdominal surgical procedures
• For diseases
• POP-Q stage III/IV for anterior and/or apical compartment; stage \<III for posterior compartment.
• No uterine cervix dysplasia or endometrial disorders.
• No uterine size larger than conform 10 weeks gestation

Sponsors & Collaborators

• Azienda Ospedaliera Cardinale G. Panico: lead

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrea Morciano, M.D.

  Pia Fondazione Giovanni Panico

  PRINCIPAL INVESTIGATOR

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: M.D.

Study Record Dates

• First Submitted: January 30, 2018
• First Posted: February 9, 2018
• Study Start: January 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: April 1, 2018
• Last Updated: March 26, 2018

Record last verified: 2018-03