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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)

Organizational Data

DRKS-ID:
DRKS00000482
Recruitment Status:
Recruiting complete, study complete
Date of registration in DRKS:
2010-07-09
Last update in DRKS:
2022-07-22
Registration type:
Prospective

Acronym/abbreviation of the study

DeloRes

URL of the study

http://www.delores-trial.eu

Brief summary in lay language

In this interventional trial two different but successfully established techniques in the treatment of rectal prolapse will be compared. It is not a comparison trial about the operative process itself but about the question which of these both procedures is the better one for the patient. Patients who participate in the trial will be informed about all terms of procedure and individual consequences. According to the random principle patients will get assigned into one or the other trial group. Both techniques (laparoscopic resection rectopexy and surgical mucosal reduction) differentiate especially in the operative access path (with or without abdominal incision) and the mechanism of recovery of the rectal prolapse. All personal data will be pseudonymized.

Brief summary in scientific language

Full-thickness prolapse of the rectum is defined as protrusion of the complete rectal wall thorugh the anus (in marked contrast to the anal prolapse where the protrusion contains just the ganoderma). The rectal prolapse can get surgically removed especially in two different pathways: transanal versus laparoscopic transabdominal. At the moment there exists no evidence-based optimal surgical algorithm how to treat the full-thickness rectal prolapse due to the fact that both paths have advantages as well as disadvantages. Particularly elder, multimorbid patients currently are treated by transanal surgery because of less invasivity and shorter intervention time. But probably the abdominal approaches offer a significantly lower rate of recurrence. The present multicenter prospective randomized trial compares two established operation techniques – laparoscopic resection rectopexy and perineal Delorme’s procedure - with prolapse recurrene as primary outcome (therefore is the follow-up after 24 month crucial). Secondarily will be also analized operation time, morbidity, mortality, postoperative duration of stationary time, life quality and obstipation as well as incontinence as important complications of the rectal prolapse (not of the surgical technique).

Health condition or problem studied

ICD10:
K62.3 - Rectal prolapse
Healthy volunteers:
No Entry

Interventions, Observational Groups

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

Endpoints

Primary outcome:
Time to recurrence of full-thickness rectal prolapse until 24 months after surgery
Secondary outcome:
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.

Study Design

Purpose:
Treatment
Allocation:
Randomized controlled study
Control:
  • Active control (effective treatment of control group)
Phase:
N/A
Study type:
Interventional
Mechanism of allocation concealment:
No Entry
Blinding:
No
Assignment:
Parallel
Sequence generation:
No Entry
Who is blinded:
No Entry

Recruitment

Recruitment Status:
Recruiting complete, study complete
Reason if recruiting stopped or withdrawn:
No Entry

Recruitment Locations

Recruitment countries:
  • Germany
  • Switzerland
Number of study centers:
Multicenter study
Recruitment location(s):
  • University medical center CHUV Lausanne
  • University medical center CHUV Lausanne
  • University medical center Klinik für Chirurgie Lübeck
  • Medical center Klinik für Chirurgie Regensburg
  • Medical center Klinik für Allgemein-, Viszeral- und Onkologische Chirurgie Berlin-Buch
  • Medical center Klinik für Allgemein-, Viszeral-, Thorax- und Kinderchirurgie Ludwigsburg
  • Doctor's practice Essen
  • University medical center Chirurgische Klinik Mannheim
  • Medical center Klinik für ​Koloproktologie Recklinghausen

Recruitment period and number of participants

Planned study start date:
2010-09-01
Actual study start date:
2010-10-13
Planned study completion date:
No Entry
Actual Study Completion Date:
2021-01-31
Target Sample Size:
130
Final Sample Size:
70

Inclusion Criteria

Sex:
All
Minimum Age:
18 Years
Maximum Age:
no maximum age
Additional 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

• 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

Addresses

Primary Sponsor

University Medical Centre Mannheim (UMM)
MD Florian Herrle
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Germany
Telephone:
+49 (621) 383 2225
Fax:
+49 (621) 383 3809
Contact per E-Mail
URL:
No Entry
Investigator Sponsored/Initiated Trial (IST/IIT):
Yes

Contact for Scientific Queries

University Medical Centre Mannheim (UMM)
MD Florian Herrle
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Germany
Telephone:
+49 (621) 383 2225
Fax:
+49 (621) 383 3809
Contact per E-Mail
URL:
No Entry

Contact for Public Queries

University Medical Centre Mannheim (UMM)
MD Florian Herrle
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Germany
Telephone:
+49 (621) 383 2225
Fax:
+49 (621) 383 3809
Contact per E-Mail
URL:
No Entry

Sources of Monetary or Material Support

Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)

DFG (Deutsche Forschungsgemeinschaft)
Kennedyallee 40
53175 Bonn
Germany
Telephone:
+49 (228) 885-1
Fax:
+49 (228) 885-2777
Contact per E-Mail
URL:
http://www.dfg.de/index.jsp

Institutional budget, no external funding (budget of sponsor/PI)

Chirurgische Klinik, University Medical Centre Mannheim (UMM)
Theodor-Kutzer-Ufer 1-3
68167 Mannheim
Germany
Telephone:
+49 (621) 383 2225
Fax:
+49 (621) 383 3809
Contact per E-Mail
URL:
No Entry

Ethics Committee

Address Ethics Committee

Medizinische Ethik-Kommission II, Mannheim, Medizinische Fakultät der Universität Mannheim Heidelberg [Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg]
Telephone:
No Entry
Fax:
No Entry
Contact per E-Mail
URL:
No Entry

Vote of leading Ethics Committee

Date of ethics committee application:
2008-04-24
Ethics committee number:
2008-254N-MA
Vote of the Ethics Committee:
Approved
Date of the vote:
2008-05-06

Further identification numbers

Other primary registry ID:
No Entry
EudraCT Number:
No Entry
UTN (Universal Trial Number):
U1111-1115-9547
EUDAMED Number:
No Entry

IPD - Individual Participant Data

Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
No
IPD Sharing Plan:
No Entry

Study protocol and other study documents

Study protocols:
No Entry
Study abstract:
No Entry
Other study documents:
Studienprotokoll
Background literature:
No Entry
Related DRKS studies:
No Entry

Publication of study results

Planned publication:
No Entry
Publikationen/Studienergebnisse:
No Entry
Date of first publication of study results:
No Entry
DRKS entry published for the first time with results:
No Entry

Basic reporting

Basic Reporting / Results tables:
No Entry
Brief summary of results:
No Entry