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Randomized trial to compare two standardized surgical approaches in rectal prolapse – surgical mucosal reduction according to Delorme vs. laparoscopic resection rectopexy (DeloRes-Trial)

Randomized trial to compare two standardized surgical approaches in rectal prolapse – surgical mucosal reduction according to Delorme vs. laparoscopic resection rectopexy (DeloRes-Trial) - DeloRes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00000482
Enrollment
130
Registered
2010-07-09
Start date
2010-10-13
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

K62.3

Interventions

Group 1: Delorme' procedure Group 2: Laparoscopic resection rectopexy

Sponsors

University Medical Centre Mannheim (UMM)
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: • Full-thickness rectal prolapse, externally visible on straining • ASA-Score I-III • Patient is suited for both standardized surgical approaches • Patient is able to cooperate and understands character and individual consequences of clinical trial • Patient has given written informed consent

Exclusion criteria

Exclusion criteria: • Recurrent full-thickness rectal prolapse • Patient with stoma • Patient with inflammatory bowel disease • Pregnancy or nursing • Patients currently undergoing chemotherapy • Active malignant disease and life expectancy lower than 24 months • Body mass index greater than 40 • Participation in another intervention-trial with interference of intervention and outcome of this study • Expected lack of compliance

Design outcomes

Primary

MeasureTime frame
Time to recurrence of full-thickness rectal prolapse until 24 months after surgery

Secondary

MeasureTime frame
Descriptive analyses of differences in treatment groups regarding operation time, morbidity, mortality, postoperative duration hospital stay, quality of life and obstipation as well as incontinence as important complications of rectal prolapse. Exploratory assessment of prognostic factors and subgroups.

Countries

Germany, Switzerland

Contacts

Public ContactFlorian Herrle

University Medical Centre Mannheim (UMM)

florian.herrle@umm.de+49 (621) 383 2225

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Mar 25, 2026