An interventional study of LPS Ventral Rectopexy in Rectal Prolapse, sponsored by Azienda Ospedaliera Cardinale G. Panico. Completed. Open to female participants aged 50 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by Azienda Ospedaliera Cardinale G. Panico · Not applicable, Interventional, and Treatment
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.
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.
55 studies on the registry are indexed under Rectal Prolapse; 12 are open to participants now.
This study's enrollment of 50 is close to the median of 55 across 34 interventional studies indexed under Rectal Prolapse.
Browse Rectal Prolapse studies →Azienda Ospedaliera Cardinale G. Panico is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
For patients
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Procedure: LPS Ventral Rectopexy
Procedure: LPS Ventral Rectopexy
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
Operative time
Operative time for RVL will be calculated from the entrance to exit from the abdominal cavity
Time frame: 1 year
No study locations are listed for this record.
Ran from Nov 2016 to primary completion in Dec 2017, 13 months.
Of 18 interventional studies with no phase under Rectal Prolapse, half reached primary completion within 58 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 94. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliera Cardinale G. Panico