Rectal Prolapse Clinical Trial
Official title:
Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse
NCT number | NCT05254860 |
Other study ID # | 201901Gineco |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | November 2016 |
Est. completion date | January 2019 |
Verified date | February 2022 |
Source | Azienda Ospedaliera Cardinale G. Panico |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | January 2019 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 50 Years to 80 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Azienda Ospedaliera Cardinale G. Panico |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Operative time | Operative time for RVL will be calculated from the entrance to exit from the abdominal cavity | 1 year |
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