The LaProS study. An international study to determine the optimal surgical treatment for rectal prolapse.

Laparoscopic Rectal Prolapse Surgery Study. An international, double cohort study to determine the optimal treatment for rectal prolapse.

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON25259

Enrollment

240

Registered

2011-02-11

Start date

2011-01-01

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Rectal prolapse (Full thickness, external)

Interventions

Cohort 1 (European Cohort): Laparoscopic Ventral Rectopexy

Cohort 2 (US Cohort): Laparoscopic Resection Rectopexy.

Eligibility

Inclusion criteria

Inclusion criteria: All patients with an external rectal prolapse and an indication for laparoscopic ventral rectopexy (for European centers) or laparoscopic resection rectopexy (for US centers).

Exclusion criteria

Exclusion criteria: 1. Under 18 years of age; 2. Former rectosigmoid resection; 3. Former rectal prolapse surgery; 4. Rectosigmoid tumor; 5. Severe mental retardation; 6. Pregnant women.

Design outcomes

Primary

Measure	Time frame
Improvement of Quality of life, objectified by the Gastro-intestinal Quality of life Index (GIQLI).	—

Secondary

Measure	Time frame
1. To evaluate the optimal surgical strategy for laparoscopic rectal prolapse surgery in terms of improving constipation and incontinence (questionnaire, validated scoring systems: Cleveland Clinic Incontinence Score and Cleveland Clinic Constipation Score); 2. To evaluate and compare post-operative morbidity measured by reoperations, reinterventions, re-admissions and serious adverse events; 3. To evaluate the best surgical technique for rectal prolapse in terms of anatomic recurrence of the prolapse, measured by defecogram in rest and during Valsava manouvre; 4. To evaluate the rate of rectal prolapse recurrence and complications (complaints, physical examination, additional research, re-operation and readmission); 5. To evaluate pelvic floor function pre- and postoperatively (questionnaire); 6. To evaluate urogenital functioning pre- and postoperatively (questionnaire and urinary diary); 7. To evaluate quality of life pre- and postoperatively (faecal incontinence, obstructed defecation, voiding and quality-of-life scoring systems); 8. To evaluate length of hospital stay, peri-operative and post-operative in-hospital mortality and morbidity; 9. To evaluate the rate of extra outpatient visits because of complaints.	—

Measure

Time frame

1. To evaluate the optimal surgical strategy for laparoscopic rectal prolapse surgery in terms of improving constipation and incontinence (questionnaire, validated scoring systems: Cleveland Clinic Incontinence Score and Cleveland Clinic Constipation Score); 2. To evaluate and compare post-operative morbidity measured by reoperations, reinterventions, re-admissions and serious adverse events; 3. To evaluate the best surgical technique for rectal prolapse in terms of anatomic recurrence of the prolapse, measured by defecogram in rest and during Valsava manouvre; 4. To evaluate the rate of rectal prolapse recurrence and complications (complaints, physical examination, additional research, re-operation and readmission); 5. To evaluate pelvic floor function pre- and postoperatively (questionnaire); 6. To evaluate urogenital functioning pre- and postoperatively (questionnaire and urinary diary); 7. To evaluate quality of life pre- and postoperatively (faecal incontinence, obstructed defecation, voiding and quality-of-life scoring systems); 8. To evaluate length of hospital stay, peri-operative and post-operative in-hospital mortality and morbidity; 9. To evaluate the rate of extra outpatient visits because of complaints.

—

Contacts

Public ContactH.A. Formijne Jonkers

Meander Medical Center, Dept. of Surgery Utrechtseweg 160

ha.formijnejonkers@meandermc.nl+31 (0)33 8502072

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)