Comparative Study Between Delorme Operation With or Without Postanal Repair in Treatment of Complete Rectal Prolapse
1 other identifier
interventional
82
1 country
1
Brief Summary
The aim of the study is to compare Delorme operation alone or with post anal repair and levatorplasty for treating complete rectal prolapse.consecutive patients who were treated for complete rectal prolapse at the Colorectal Surgery Unit were eligible for the study.The patients were randomized into two groups: Group I: consisted of patients were subjected to delorme operation only. Group II: consisted of patients were subjected to delorme operation with post anal repair and levatorplasty.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2007
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 26, 2012
CompletedFirst Posted
Study publicly available on registry
August 3, 2012
CompletedNovember 23, 2015
January 1, 2007
4.4 years
July 26, 2012
November 20, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
recurrence rate
recurrence rate
one year postoperative
Secondary Outcomes (4)
changes of bowel habit
early postoperative, after 1 year
incontinence
30 day postoperative,and one year postoperative
manometric study
one year postoperative
complications
30 day postoperative
Study Arms (2)
Group I delorme operation only.
ACTIVE COMPARATORA circumferential incision was made in the rectal mucosa approximately 1 cm away from the dentate line. Using electrocautery, the mucosa was stripped to the apex of the prolapse. The muscular layers of the rectal wall were reduced as the mucosa was stripped. Mucosal stripping continued past the apex of the prolapse and then continued inside the prolapsed segment to a point internally that is equivalent to the point of the initial mucosal incision. The underling muscle was plicated by vicryl 2/0.The muscle bite was taken longitudinally from 8 sides to reach a horizontal line of plication at the end. The mucosa was then reanastomosed. Postoperatively, minimal pain medication was required. Early ambulation was encouraged, and patients' diets were advanced as tolerated.
delorme operation with post anal repair
ACTIVE COMPARATORIn group II : post anal repair was added by making transverse incision 7cm behind the anal canal.dissection of intersphincteric plain,plication of internal sphincter by using 3/0 vicryl.The levator ani and external sphincter were then sutured to each other by vicryl 2/0 behind the anal canal followed by skin closure without drain.
Interventions
A circumferential incision was made in the rectal mucosa approximately 1 cm away from the dentate line. Using electrocautery, the mucosa was stripped to the apex of the prolapse. The muscular layers of the rectal wall were reduced as the mucosa was stripped. Mucosal stripping continued past the apex of the prolapse and then continued inside the prolapsed segment to a point internally that is equivalent to the point of the initial mucosal incision. The underling muscle was plicated by vicryl 2/0.The muscle bite was taken longitudinally from 8 sides to reach a horizontal line of plication at the end. The mucosa was then reanastomosed.
In group II : post anal repair was added by making transverse incision 7cm behind the anal canal.dissection of intersphincteric plain,plication of internal sphincter by using 3/0 vicryl.The levator ani and external sphincter were then sutured to each other by vicryl 2/0 behind the anal canal followed by skin closure without drain.
Eligibility Criteria
You may qualify if:
- complete rectal prolapse
You may not qualify if:
- pregnant female
- any patients with previous anal surgery
- pudendal nerve neuropathy
- anal fistula and sepsis or coagulopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ayman El Nakeeb
Al Mansurah, Egypt
Related Publications (1)
Youssef M, Thabet W, El Nakeeb A, Magdy A, Alla EA, El Nabeey MA, Fouda el Y, Omar W, Farid M. Comparative study between Delorme operation with or without postanal repair and levateroplasty in treatment of complete rectal prolapse. Int J Surg. 2013;11(1):52-8. doi: 10.1016/j.ijsu.2012.11.011. Epub 2012 Nov 24.
PMID: 23187047DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
ayman el nakeeb, MD
Mansoura University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- mansoura university
Study Record Dates
First Submitted
July 26, 2012
First Posted
August 3, 2012
Study Start
January 1, 2007
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
November 23, 2015
Record last verified: 2007-01