Rectal ProlapseNCT03643393
Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure
A study testing perineal rectosigmoidectomy in people with Rectal Prolapse, run by Viet Duc University Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 52 to 69 years, men only
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- perineal rectosigmoidectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2015to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 52 to 69 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 2 cases incarceration rectalprolapse
Who cannot join
- N/A
About this study
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.
- Conditions
- Rectal Prolapse
- Being tested
- perineal rectosigmoidectomy
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
perineal rectosigmoidectomyProcedure or surgery
Also called Altemeier's procedure
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.
| Study group | Role | What they receive |
|---|---|---|
| incarceration rectal prolapse | Other | Not described Receives: Procedure: perineal rectosigmoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
recurrent rectal prolapse
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
Measured: 3 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 May 2015
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Viet Duc University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- xuan hung nguyen, DR, Study chair, center of colorectal surgery - viet duc university hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643393
- Sponsor's protocol ID
- HMTT-VD-2018
- Status last verified
- Aug 2018
- First submitted
- 31 Jul 2018
- Last updated
- 22 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Report 2 Cases of Massive Incarceration Necrosis Rectal Prolapse Are Successfully Treated With Altemeier's Procedure
- ClinicalTrials.gov ID
- NCT03643393
- Acronym / sponsor ID
- HMTT-VD-2018
- Conditions
- Rectal Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Viet Duc University HospitalUniversity, hospital or other
- Study start
- 1 May 2015 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 22 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| incarceration rectal prolapse | Other | Procedure: perineal rectosigmoidectomy |
Who may qualify
- Ages
- 52 to 69 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 2 cases incarceration rectalprolapse
Key exclusion criteria (1 listed)
- N/A
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| perineal rectosigmoidectomyAlso: Altemeier's procedureIn 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. | Procedure or surgery | incarceration rectal prolapse |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2018.
- Individual participant dataSharing planned: Undecided
Related trials for Rectal Prolapse
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruitingObservational study
Clinical Outcomes of Rectopexy for Rectal Prolapse
Rectal Prolapse, Fecal Incontinence
Enrolling by invitationObservational study
Data-driven Clustering in Hemorrhoid Surgery: Retrospective Monocentric Study for the Identification of Clinical Phenotypes
Hemorrhoid, Hemorrhoid Prolapse
Active, not recruiting
RECTOSACROUTEROPEXY vs. WELLS
Rectal Prolapse, Pelvic Organ Prolapse (POP)
Recruiting
Evaluation of SINGLE PORT (SP) Robotic Technology in Colorectal Surgery
Colo-rectal Cancer, Rectal Prolapse
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xuan hung nguyen, DR study chair
center of colorectal surgery - viet duc university hospital
Questions about this trial
What is this clinical trial studying?
A study testing perineal rectosigmoidectomy in people with Rectal Prolapse, run by Viet Duc University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
recurrent rectal prolapse (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2018.