Continuous Locked Non-barbed Suture for Mesh Fixation During Laparoscopic Ventral Rectopexy for Severe Rectal Prolapse
Condition: Rectal Prolapse
MeSH terms: Rectal Prolapse; Prolapse
Study type: Interventional

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.
    

Intervention name(s): LPS Ventral Rectopexy
Intervention type(s): Procedure
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ventral rectopexy; laparoscopy; prolapse