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

Withdrawn

• Conditions: rectal prolaps; 10017998

• Registration Number: NL-OMON33144
• Lead Sponsor: Meander Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Withdrawn
• Sex: Not specified
• Target Recruitment: 330

Inclusion Criteria

-Internal or external full thickness rectal prolapse

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Primary endpoint is the post-operative morbidity, measured by the number of<br /><br>hospital re-admissions and surgical reintervention needed. </p><br>

Secondary Outcome Measures

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