Rectal ProlapseNCT05254860
Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse
A study testing LPS Ventral Rectopexy in people with Rectal Prolapse, run by Azienda Ospedaliera Cardinale G. Panico.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- LPS Ventral Rectopexy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
None listed.
About this study
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.
Read the 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.
- Conditions
- Rectal Prolapse
- Being tested
- LPS Ventral Rectopexy
- Keywords
- ventral rectopexy, laparoscopy, prolapse
- Medical subject headings
- Rectal Prolapse, Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LPS Ventral RectopexyProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Interrupted suture | Experimental | Not described Receives: Procedure: LPS Ventral Rectopexy |
| Continous suture | Experimental | Not described Receives: Procedure: LPS Ventral Rectopexy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Operative time
Operative time for RVL will be calculated from the entrance to exit from the abdominal cavity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study startNov 2016
- Primary completionDec 2017
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Cardinale G. Panico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrea Morciano, Azienda Ospedaliera Cardinale G. Panico
- Investigators
- Andrea Morciano, M.D., Principal investigator, Pia Fondazione Panico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05254860
- Sponsor's protocol ID
- 201901Gineco
- Status last verified
- Feb 2022
- First submitted
- 13 Feb 2022
- Last updated
- 24 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 35835920
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse
- ClinicalTrials.gov ID
- NCT05254860
- Acronym / sponsor ID
- 201901Gineco
- Conditions
- Rectal Prolapse
- Keywords
- ventral rectopexy, laparoscopy, prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Azienda Ospedaliera Cardinale G. PanicoUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 24 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interrupted suture | Experimental | Procedure: LPS Ventral Rectopexy |
| Continous suture | Experimental | Procedure: LPS Ventral Rectopexy |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- For patients
- Age ≤ 80 years
- Patient's informed consent
- American Society of Anesthesiologists: < class III or IV
- Physiologic, surgical or iatrogenic menopause.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LPS Ventral RectopexyContinuous 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 | Procedure or surgery | Continous suture, Interrupted suture |
Primary outcome
Operative time
Time frame: 1 year
Operative time for RVL will be calculated from the entrance to exit from the abdominal cavity
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2022.
- Derived from this study: PubMed 35835920Morciano 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.
Related trials for Rectal Prolapse
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Clinical Outcomes of Rectopexy for Rectal Prolapse
Rectal Prolapse, Fecal Incontinence
Enrolling by invitationObservational study
Data-driven Clustering in Hemorrhoid Surgery: Retrospective Monocentric Study for the Identification of Clinical Phenotypes
Hemorrhoid, Hemorrhoid Prolapse
Active, not recruiting
RECTOSACROUTEROPEXY vs. WELLS
Rectal Prolapse, Pelvic Organ Prolapse (POP)
Recruiting
Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
Colo-rectal Cancer, Rectal Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrea Morciano, M.D. principal investigator
Pia Fondazione Panico
Questions about this trial
What is this clinical trial studying?
A study testing LPS Ventral Rectopexy in people with Rectal Prolapse, run by Azienda Ospedaliera Cardinale G. Panico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Operative time (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05254860, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2022.