Biological OviTex versus synthetic graft in robotic prolapse surgery: a multicentre, phase II-III, partially randomized patient preference trial

Biological OviTex versus synthetic graft in robotic prolapse surgery: a multicentre, phase II-III, partially randomized patient preference trial - ProTex

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54397

Enrollment

184

Registered

2023-08-01

Start date

2023-12-05

Completion date

Unknown

Last updated

2024-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intussusception Rectal prolapse

Interventions

The primary aim of this study is to compare prolapse surgery with OviTex instead of the current standard polypropylene mesh (Prolene, Ethocin Inc, Johnson & Johnson, Hamburg, Germany

weight 80-85 g/m2) in adult patients with a rectal prolapse and/or pelvic prolapse performed by experienced surgeons. Study participants will have 2 additional follow-up moments (each including the

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Indication for ventral mesh rectopexy with or without sacrocolpopexy Informed consent for OviTex or Polypropylene Age of 18 years or older Able to complete questionnaires and outpatient visits

Exclusion criteria

Exclusion criteria: Mental incompetence Allergy to ovine rumen

Design outcomes

Primary

Measure	Time frame
Study parameters/endpoints Main study parameter/endpoint phase II - Post-operative morbidity measured by reoperations, reinterventions, re-admissions, serious adverse events, Clavien Dindo classification and CTS classification. - The rate of rectal prolapse recurrence and complications (complaints, physical examination, addition research, re-operation and readmission). Main study parameter/endpoint phase III Constipation, incontinence and urogenital functioning (questionnaire, validated scoring system: Fecal Incontinence Severity Index (FISI), Altomare obstructive defecation score (ODS)) and Pelvic Floor Distress Inventory-20 (PFDI-20).	—

Measure

Time frame

Study parameters/endpoints Main study parameter/endpoint phase II - Post-operative morbidity measured by reoperations, reinterventions, re-admissions, serious adverse events, Clavien Dindo classification and CTS classification. - The rate of rectal prolapse recurrence and complications (complaints, physical examination, addition research, re-operation and readmission). Main study parameter/endpoint phase III Constipation, incontinence and urogenital functioning (questionnaire, validated scoring system: Fecal Incontinence Severity Index (FISI), Altomare obstructive defecation score (ODS)) and Pelvic Floor Distress Inventory-20 (PFDI-20).

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Secondary

Measure	Time frame
Secondary study parameters/endpoints - Quality of life (QoL) pre- and postoperatively objectified primarily by the Patient Assessment of Constipation-Quality of Life Questionnaire (PAC-QoL), Fecal Incontinence Quality of Life Scale (FIQL), Pelvic Floor impact Questionnaire (PFIQ-7), Patient Global Impression of Improvement (PGI-I), Patient Global Impression of Severity (PGI-S) and European Quality of Life Five Dimension (EQ-5D). - Post-operative morbidity measured by reoperations, reinterventions, re-admissions, and serious adverse advents. - Anatomic recurrence of the prolapse, measured by defecogram or MR defecography in rest and during Valsalva maneuver. - Rate of rectal prolapse recurrence and complications (complaints, physical examination, addition research, re-operation and readmission). - Anatomic recurrence of pelvic organ prolapse (POP) using the simplified Pelvic Organ Prolapse Quantification (sPOPQ) - Sexual functioning pre- and postoperatively by the questionnaire Prolapse Incontinence Sexual Inventory Questionnaire (PSIQ-12). - Length of hospital stay, peri-operative and post-operative in hospital mortality and morbidity. - Rate of extra outpatient visits because of complaints.	—

Measure

Time frame

Secondary study parameters/endpoints - Quality of life (QoL) pre- and postoperatively objectified primarily by the Patient Assessment of Constipation-Quality of Life Questionnaire (PAC-QoL), Fecal Incontinence Quality of Life Scale (FIQL), Pelvic Floor impact Questionnaire (PFIQ-7), Patient Global Impression of Improvement (PGI-I), Patient Global Impression of Severity (PGI-S) and European Quality of Life Five Dimension (EQ-5D). - Post-operative morbidity measured by reoperations, reinterventions, re-admissions, and serious adverse advents. - Anatomic recurrence of the prolapse, measured by defecogram or MR defecography in rest and during Valsalva maneuver. - Rate of rectal prolapse recurrence and complications (complaints, physical examination, addition research, re-operation and readmission). - Anatomic recurrence of pelvic organ prolapse (POP) using the simplified Pelvic Organ Prolapse Quantification (sPOPQ) - Sexual functioning pre- and postoperatively by the questionnaire Prolapse Incontinence Sexual Inventory Questionnaire (PSIQ-12). - Length of hospital stay, peri-operative and post-operative in hospital mortality and morbidity. - Rate of extra outpatient visits because of complaints.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)