- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03643393
Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure
August 20, 2018 updated by: Viet Duc University Hospital
Incarceration and necrosis of rectal prolapse is rare and often requires urgent management.
Perineal rectosigmoidectomy (Altemeir procedure) is a reasonable technique for this condition.
The need for a diverting stoma depends on the patient's condition and the experience and judgement of the surgeon.
A literature review was performed to determine optimal management of incarcerated and necrotic rectal prolapse, and to determine the indication for fecal diversion.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
2
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
52 years to 69 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- 2 cases incarceration rectalprolapse
Exclusion Criteria:
- N/A
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: incarceration rectal prolapse
|
In an Altemeier perineal rectosigmoidectomy, a full-thickness circumferential incision is made in the prolapsed rectum about 1-2 cm from the dentate line (see the image below).
The hernia sac is entered, and the prolapse is delivered.
The mesentery of the prolapsed bowel is serially ligated until no further redundant bowel can be pulled down.
The bowel is transected and either hand-sewn to the distal anal canal or stapled with a circular stapler.
Before anastomosis, some surgeons plicate the levator ani muscles anteriorly, which may help improve continence.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
recurrent rectal prolapse
Time Frame: 3 months after surgery
|
patients were asked for symptoms such as: pain during bowel movements, mucus or blood discharge from the protruding tissue, a loss of urge to defecate, awareness of something protruding upon wiping
|
3 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: xuan hung nguyen, DR, center of colorectal surgery - viet duc university hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2015
Primary Completion (Actual)
June 30, 2018
Study Completion (Actual)
June 30, 2018
Study Registration Dates
First Submitted
July 31, 2018
First Submitted That Met QC Criteria
August 20, 2018
First Posted (Actual)
August 22, 2018
Study Record Updates
Last Update Posted (Actual)
August 22, 2018
Last Update Submitted That Met QC Criteria
August 20, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HMTT-VD-2018
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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