Clinical trial NCT04564677: A Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
Official title: A Prospective Study Evaluating the Clinical Outcome of a Modified d'Hoore Technique for Laparoscopic Ventral Mesh Rectopexy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rectocele
Enterocele
Rectal Prolapse
Lead sponsor: Duomed
Sponsor class: INDUSTRY
First posted: 2020-09-25
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female patients with primary rectal prolapse, rectocele and/or enterocele eligible for laparoscopic ventral mesh rectopexy.

Brief summary: The purpose of this observational study is to evaluate the clinical outcome of a modified d'Hoore technique for laparoscopic ventral mesh rectopexy in patients with primary rectal prolapse, rectocele and/or enterocele.The goal of the study will be achieved by reporting the peri- and postoperative complications ((serious) adverse events), recurrences and re-interventions. Pre-operative to postoperative changes in pain, functional outcome and quality of life will be evaluated as well.


Eligibility criteria: Inclusion Criteria:

* Female patients.
* Patient ≥ 18 years of age at study entry.
* Patient and investigator signed and dated the informed consent form prior to the index-procedure.
* Patient with primary rectal prolapse (grades I to V according to the Oxford scale), rectocele and/or enterocele.

Exclusion Criteria:

* Patient is unable / unwilling to provide informed consent.
* Patient with recurrent rectal prolapse, rectocele and/or enterocele.
* Patient is unable to comply with the study protocol or proposed follow-up visits.
* Patient has a contra-indication for laparoscopic ventral mesh rectopexy.

Primary outcomes:
measure: Procedural efficacy - Number of participants with (serious) adverse events
timeFrame: During procedure
measure: Procedural efficacy - Conversion rate to laparotomy during the index procedure
timeFrame: During procedure
measure: Procedural efficacy - Number of participants with (serious) adverse events
timeFrame: At discharge (assessed up to 1 week)
measure: Procedural efficacy - Number of re-interventions
timeFrame: At discharge (assessed up to 1 week)
measure: Procedural efficacy - Number of participants with (serious) adverse events
timeFrame: Follow-up 1: 6 - 10 weeks after the procedure
measure: Procedural efficacy - Number of re-interventions
timeFrame: Follow-up 1: 6 - 10 weeks after the procedure
measure: Procedural efficacy - Number of post-operative recurrences
timeFrame: Follow-up 1: 6 - 10 weeks after the procedure
measure: Procedural efficacy - Number of participants with (serious) adverse events
timeFrame: Follow-up 2: 12 months after the procedure
measure: Procedural efficacy - Number of re-interventions
timeFrame: Follow-up 2: 12 months after the procedure
measure: Procedural efficacy - Number of post-operative recurrences
timeFrame: Follow-up 2: 12 months after the procedure
measure: Procedural efficacy - Number of participants with (serious) adverse events
timeFrame: Follow-up 3: 24 months after the procedure
measure: Procedural efficacy - Number of re-interventions
timeFrame: Follow-up 3: 24 months after procedure
measure: Procedural efficacy - Number of post-operative recurrences
timeFrame: Follow-up 3: 24 months after the procedure
measure: Procedural efficacy - Number of participants with (serious) adverse events
timeFrame: Follow-up 4: 36 months after the procedure
measure: Procedural efficacy - Number of re-interventions
timeFrame: Follow-up 4: 36 months after the procedure
measure: Procedural efficacy - Number of post-operative recurrences
timeFrame: Follow-up 4: 36 months after the procedure
Secondary outcomes:
measure: Pre-operative abdominal pain by means of the Visual Analogue Scale (VAS)
timeFrame: At baseline
measure: Pre-operative vaginal pain by means of the Visual Analogue Scale (VAS)
timeFrame: At baseline
measure: Functional score - Obstructive Defecation Syndrome (ODS) score
timeFrame: At baseline
measure: Functional score - Cleveland Clinical Incontinence Score (CCIS)
timeFrame: At baseline
measure: Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
timeFrame: At baseline
measure: Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
timeFrame: Follow-up 1: 6 - 10 weeks after the procedure
measure: Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
timeFrame: Follow-up 2: 12 months after the procedure
measure: Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
timeFrame: Follow-up 3: 24 months after the procedure
measure: Post-operative abdominal pain by means of the Visual Analogue Scale (VAS)
timeFrame: Follow-up 4: 36 months after the procedure
measure: Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
timeFrame: Follow-up 1: 6 - 10 weeks after the procedure
measure: Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
timeFrame: Follow-up 2: 12 months after the procedure
measure: Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
timeFrame: Follow-up 3: 24 months after the procedure
measure: Post-operative vaginal pain by means of the Visual Analogue Scale (VAS)
timeFrame: Follow-up 4: 36 months after the procedure
measure: Functional score - Obstructive Defecation Syndrome (ODS) score
timeFrame: Follow-up 1: 6 - 10 weeks after the procedure
measure: Functional score - Obstructive Defecation Syndrome (ODS) score
timeFrame: Follow-up 2: 12 months after the procedure
measure: Functional score - Obstructive Defecation Syndrome (ODS) score
timeFrame: Follow-up 3: 24 months after the procedure
measure: Functional score - Obstructive Defecation Syndrome (ODS) score
timeFrame: Follow-up 4: 36 months after the procedure
measure: Functional score - Cleveland Clinical Incontinence Score (CCIS)
timeFrame: Follow-up 1: 6 - 10 weeks after the procedure
measure: Functional score - Cleveland Clinical Incontinence Score (CCIS)
timeFrame: Follow-up 2: 12 months after the procedure
measure: Functional score - Cleveland Clinical Incontinence Score (CCIS)
timeFrame: Follow-up 3: 24 months after the procedure
measure: Functional score - Cleveland Clinical Incontinence Score (CCIS)
timeFrame: Follow-up 4: 36 months after the procedure
measure: Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
timeFrame: Follow-up 1: 6 - 10 weeks after the procedure
measure: Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
timeFrame: Follow-up 2: 12 months after the procedure
measure: Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
timeFrame: Follow-up 3: 24 months after the procedure
measure: Quality of life - Birmingham Bowel and Urinary Symptoms Questionnaire (BBUSQ)
timeFrame: Follow-up 4: 36 months after the procedure
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: Ziekenhuis Oost-Limburg (ZOL)
Study officials:
affiliation: Ziekenhuis Oost-Limburg (ZOL)
name: Anne Dams, MD
role: PRINCIPAL_INVESTIGATOR
References: