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Laparoscopische Rectal Prolapse Surgery. A two armed randomized clinical trial to compare Laparoscopic Ventral Rectopexy with Laparoscopic Resection Rectopexy for rectal prolapse surgery

Laparoscopische Rectal Prolapse Surgery. A two armed randomized clinical trial to compare Laparoscopic Ventral Rectopexy with Laparoscopic Resection Rectopexy for rectal prolapse surgery - Laparoscopic Rectal Prolapse Surgery (LaProS)-study

Status
Unknown
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON33144
Enrollment
330
Registered
2010-01-19
Start date
Unknown
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

rectal prolaps

Interventions

Two standardized surgical intervention techniques are compared. The first is the laparoscopic resection rectopexy (Frykman-Goldberg procedure, LRR), in which the rectal prolapse is treated by a rese

Sponsors

Meander Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: -Internal or external full thickness rectal prolapse

Exclusion criteria

Exclusion criteria: -Under 18 years old -No rectal prolapse but bal or mucosa prolapse -Rectosigmoid tumor or extensive diverticulitis -Former rectosigmoid resection or rectal/vaginal prolapse surgery

Design outcomes

Primary

MeasureTime frame
Primary endpoint is the post-operative morbidity, measured by the number of hospital re-admissions and surgical reintervention needed.

Secondary

MeasureTime frame
Secondary endpoints are the comparision of pre- and postoperative: quality-of-life, incontinence (Vaizey-score), constipation (Altomare score), recurrence (physical exam / defecogram) and urogenital functioning (questionnaire and micturition diary). Futhermore, length of hospital stay, mortality, total in-hospital costs and the rate of extra outpatient visits are compared.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)