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Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse

Primary Purpose

Rectal Prolapse

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
LPS Ventral Rectopexy
Sponsored by
Azienda Ospedaliera Cardinale G. Panico
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rectal Prolapse focused on measuring ventral rectopexy, laparoscopy, prolapse

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Interrupted suture

    Continous suture

    Arm Description

    Outcomes

    Primary Outcome Measures

    Operative time
    Operative time for RVL will be calculated from the entrance to exit from the abdominal cavity

    Secondary Outcome Measures

    Full Information

    First Posted
    February 13, 2022
    Last Updated
    February 23, 2022
    Sponsor
    Azienda Ospedaliera Cardinale G. Panico
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05254860
    Brief Title
    Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse
    Official Title
    Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    February 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 2016 (Actual)
    Primary Completion Date
    December 2017 (Actual)
    Study Completion Date
    January 2019 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Azienda Ospedaliera Cardinale G. Panico

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic ventral rectopexy for the treatment of severe rectal prolapse could be further reduced using a continuous locked suture vs. conventional single 6-points suture for mesh fixation.
    Detailed Description
    Introduction Laparoscopic ventral rectopexy could be considered the gold standard procedure for rectal prolapse because provides the potential to combine the success rates of an abdominal approach with the faster recovery associated with a minimally invasive technique. Tissue dissection and mesh placement may also be facilitated by the magnification and field of view permitted by the laparoscopic approach. These benefits must be balanced against a longer operating time from 150 to 250 minutes according to surgeons' experience. This prospective randomized pilot study is aimed to verify if the operative time of a standard laparoscopic ventral rectopexy for the treatment of rectal prolapse could be further reduced using using a continuous locked suture vs. conventional 6-points single suture for mesh fixation. Secondary endopoints of this comparison are incidence of intra- or postoperative complications estimated blood loss, postoperative pain (evaluated by VAS), days of hospitalization and costs for the health care system. Statistical Analysis and Study Design This is a single Institution prospective randomized clinical trial conducted at the Pia Fondazione Panico of Tricase, Italy. To have an imbalanced results and to reduce any bias, a randomization list has been checked. Probability (p) values will be considered to be statistically significant at the <0.05 level. There will be recruited 25 patients to treat using continuous locked suture and 25 patients to treat with standard 6-points single suture for mesh fixation comparing these two techniques in terms of operative time, estimated blood loss and other intra- or post operative complications, postoperative pain, days of hospitalization, costs. All patients will be adequately informed and inserted in the study only after having read and signed an informed consent. Diagnostic, clinical and surgical data of each patient will be prospectively recorded. At the end of the procedure, a schedule will be compiled with intraoperative data. All clinical and histologic data will be recorded prospectively using a database. Pain associated with the procedure will be evaluated by a subjective assessment (analysis of VAS scale values reported by patients at 8 and 24 hours after surgery). Post-operative complications will be evaluated during the first 30 days after surgery according to Dindo's classification.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Rectal Prolapse
    Keywords
    ventral rectopexy, laparoscopy, prolapse

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Interrupted suture
    Arm Type
    Experimental
    Arm Title
    Continous suture
    Arm Type
    Experimental
    Intervention Type
    Procedure
    Intervention Name(s)
    LPS Ventral Rectopexy
    Intervention Description
    Continuous Locked Suture vs Traditional 6-points suture for Laparoscopic Ventral Rectopexy to verify if the operative time of a standard laparoscopic ventral rectopexy for the treatment of severe rectal prolapse could be further reduced using continuous locked suture vs traditional 6-points suture for mesh fixation
    Primary Outcome Measure Information:
    Title
    Operative time
    Description
    Operative time for RVL will be calculated from the entrance to exit from the abdominal cavity
    Time Frame
    1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    50 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Andrea Morciano, M.D.
    Organizational Affiliation
    Pia Fondazione Panico
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    35835920
    Citation
    Morciano A, Caliandro D, Campagna G, Panico G, Giaquinto A, Fachechi G, Zullo MA, Tinelli A, Ercoli A, Scambia G, Cervigni M, Marzo G. Laparoscopic ventral rectopexy plus sacral colpopexy: continuous locked suture for mesh fixation. A randomized clinical trial. Arch Gynecol Obstet. 2022 Nov;306(5):1573-1579. doi: 10.1007/s00404-022-06682-2. Epub 2022 Jul 15.
    Results Reference
    derived

    Learn more about this trial

    Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse

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