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
About this trial
This is an interventional treatment trial for Rectal Prolapse focused on measuring ventral rectopexy, laparoscopy, prolapse
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
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
NCT ID
NCT05254860
First Posted
February 13, 2022
Last Updated
February 23, 2022
Sponsor
Azienda Ospedaliera Cardinale G. Panico
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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