This prospective study aims to assess the efficacy of the OviTex 1S permanent mesh in pelvic floor surgery in comparison with the current standard polypropylene mesh.
Indication for VMR or SCR set by the treating surgeon/gynecologist in accordance to the current guidelines on rectal and pelvic prolapse;
Counselled for therapeutic options and given informed consent for VMR or SCR;
Counselled for different types of mesh (OviTex or Prolene) and randomisation;
Written informed consent for randomisation, OviTex implant or Prolene;
Mentally incompetent patients (unable to fulfil questionnaires).
Allergy to ovine rumen.
A medical history of pelvic radiation therapy.
Scheduled for a redo-rectopexy.
Parallel
Minimal invasive abdominal prolapse surgery using Polypropylene mesh
Procedure/SurgeryAll procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).
Minimal invasive abdominal prolapse surgery using OviTex 1S permanent mesh
Procedure/SurgeryAll procedures will be performed with robotic assistance of the da Vinci Si-HD (intuitive Surgical, Inc, Sunnyvale, CA).
Main study parameter/endpoint phase II: rate of complications
Post-operative complications. The Clavien Dindo Classification is used to rank the severity of a surgical complication
Main study parameter/endpoint phase ll: number of participants with post-operative morbidity
Post-operative morbidity measured by reoperations, reinterventions, readmissions,
Main study parameter/endpoint phase Ill: Pelvic Floor Distress lnventory-20 score (PFDl-20)
Constipation, incontinence and urogenital functioning (questionnaire, validated scoring system: Pelvic Floor Distress lnventory-20 (PFDl-20). The Pelvic Floor Distress Inventory-20 (PFDI-20) is a questionnaire used to assess the presence and severity of symptoms related to pelvic floor disorders. The PFDI-20 consists of 20 questions divided into three subscales: the Pelvic Organ Prolapse Distress Inventory (POPDI), the Colorectal-Anal Distress Inventory (CRADI), and the Urinary Distress Inventory (UDI). Scale Details: Minimum Score: 0 Maximum Score: 300 Interpretation: Higher scores indicate a worse outcome, reflecting greater distress or more severe symptoms.
Constipation
Questionnaire, validated scoring system: Altomare obstructive defecation score (ODS) with a maximum score of 31. A higher score on the Altomare scale indicates a greater severity of constipation. Scores will be compared before and after treatment.
Incontinence
Questionnaire, validated scoring system: Fecal Incontinence Severity Index (FISI) with a maximum score of 60. A higher FISI score indicates more severe fecal incontinence. Scores will be compared before and after treatment.
Quality of life (Qol) pre- and postoperatively by the Patient Global Impression of Improvement (PGl-I).
Objectified primarily by the Patient Global Impression of Improvement (PGl-I). The PGI-I scale measures the patient's perception of improvement (or lack thereof) in their condition following treatment. 1 - Very much improved: Significant improvement in condition. 2 - Much improved: Noticeable improvement in condition. 3 - Minimally improved: Slight improvement in condition. 4 - No change: Condition has not changed. 5 - Minimally worse: Slight worsening of condition. 6 - Much worse: Noticeable worsening of condition. 7 - Very much worse: Significant worsening of condition.
Quality of life (Qol) pre- and postoperatively by the Patient Global Impression of Severity (PGl-S).
Objectified primarily by the Patient Global Impression of Severity (PGl-S). The PGI-S scale measures the patient's perception of the severity of their condition at a specific point in time. 1 - Normal: No symptoms. 2 - Borderline: Barely noticeable symptoms. 3 - Mild: Symptoms are present but do not significantly interfere with daily activities. 4 - Moderate: Symptoms are more noticeable and do interfere with daily activities. 5 - Severe: Symptoms are significant and very disruptive to daily activities. 6 - Very severe: Symptoms are extremely disruptive and may prevent daily activities. 7 - Extremely severe: Symptoms are debilitating.
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Meander Medical Center
Lead sponsor
Health Holland
Collaborator
