Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse
1 other identifier
interventional
50
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2016
Typical duration for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 13, 2022
CompletedFirst Posted
Study publicly available on registry
February 24, 2022
CompletedFebruary 24, 2022
February 1, 2022
1.1 years
February 13, 2022
February 23, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Operative time
Operative time for RVL will be calculated from the entrance to exit from the abdominal cavity
1 year
Study Arms (2)
Interrupted suture
EXPERIMENTALContinous suture
EXPERIMENTALInterventions
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
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Related Publications (1)
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.
PMID: 35835920DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrea Morciano, M.D.
Pia Fondazione Panico
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
- Principal Investigator
Study Record Dates
First Submitted
February 13, 2022
First Posted
February 24, 2022
Study Start
November 1, 2016
Primary Completion
December 1, 2017
Study Completion
January 1, 2019
Last Updated
February 24, 2022
Record last verified: 2022-02