Rectal ProlapseNCT01980043
Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse
A study testing endoluminal rectal prolapse repair under sedation in people with Rectal Prolapse, run by Weill Medical College of Cornell University at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Read more about this study
- Who is it for?
- Ages 75 to 100 years
- Conditions the study is for
- Rectal Prolapse
- What is being tested?
- endoluminal rectal prolapse repair under sedation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2013to 22 Mar 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 75 to 100 years
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age, 75 years and older, Male and Female
- BMI above 18 and ≤30
- ASA class 1-3
- willing to participate in the study
Who cannot join
- ASA class 4-5
- Previous Abdominal Surgeries including abdominal wall repair with mesh
Trial locations and contacts
1 site in 1 country.
United States1 site
Weill Cornell Medical Center- NYPH
New York, New York, 10065
About this study
Official title: Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia
The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, investigators will evaluate the short and long-term clinical outcomes after this novel approach to treating rectal prolapse.
Read the detailed description
.Aims/Objective The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, we will evaluate the short and long-term clinical outcomes after this new procedure.
Primary Outcomes
- Feasibility: successful completion of endoluminal rectal prolapse repair with needlescopic assistance
- Safety: measured by the incidence of the Intraoperative complications (bowel perforation, organ injury and bleeding requiring blood transfusion)
- Sedation and local anesthesia feasibility: surgery completed without patient intubation
- Clinical Outcomes: rectal prolapse recurrence within 30 days, length of hospital stay and postsurgical complications
- Long Term Clinical Outcomes: Rectal Prolapse Recurrence
Methods Design: A prospective pilot study with 10 patients who will be undergoing Combined Needlescopic and Endoluminal (Colonoscopic) Surgery under sedation and local anesthesia for Rectal Prolapse Repair with the Colon and Rectal Surgeons at WCMC. Data will be collected prospectively before, during, and after surgery.
Settings: Colon and Rectal Surgery at WCMC-NYPH Population: Patients male and female above 75 years of age, with rectal prolapse will be invited to participate in the study after surgery is deemed necessary for standard treatment of their medical conditions.
- Conditions
- Rectal Prolapse
- Being tested
- endoluminal rectal prolapse repair under sedation
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoluminal rectal prolapse repair under sedationProcedure or surgery
endoluminal rectal prolapse repair under sedation
| Study group | Role | What they receive |
|---|---|---|
| Rectal Prolapse | Other | endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Receives: Procedure: endoluminal rectal prolapse repair under sedation |
What is being measured
The primary outcome is the main question the study is designed to answer.
rectal prolapse recurrence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2013 (estimated)
- Study start20 May 2013
- Primary completion22 Mar 2018
- Study completion22 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rectal ProlapseStudies of the same condition, open and under way.
- More trials run by Weill Medical College of Cornell UniversityThe sponsor's other registered studies.
- 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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Weill Medical College of Cornell University
- Sponsor type
- University, hospital or other
- Collaborators
- Olympus
- Responsible party
- Sponsor
- Investigators
- Jeffrey W Milsom, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01980043
- Sponsor's protocol ID
- 1209013050
- Status last verified
- Jul 2019
- First submitted
- 1 Nov 2013
- Last updated
- 30 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Milsom JW, Trencheva K, Gadalla F, Abramovitz S, Garrett KA. Rectal Prolapse Repair with Abdominal Fixation Under Sedation and Local or Epidural Anesthesia: Prospective Pilot Study in 10 Elderly Subjects. J Laparoendosc Adv Surg Tech A. 2021 Aug;31(8):911-916. doi: 10.1089/lap.2019.0804. Epub 2020 Oct 21.
PubMed 33090077
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endoluminal and Needlescopic Assisted Repair of Rectal Prolapse With Abdominal Fixation Under Sedation and Local Anesthesia
- ClinicalTrials.gov ID
- NCT01980043
- Acronym / sponsor ID
- 1209013050
- Conditions
- Rectal Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Weill Medical College of Cornell UniversityUniversity, hospital or other
- Collaborators
- Olympus
- Study start
- 20 May 2013 (actual)
- Primary completion
- 22 Mar 2018 (actual)
- Study completion
- 22 Mar 2018 (actual)
- First posted
- 8 Nov 2013 (estimated)
- 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.
The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, investigators will evaluate the short and long-term clinical outcomes after this novel approach to treating rectal prolapse.
Detailed description
.Aims/Objective The purpose of this study is to evaluate the safety and feasibility of endoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. Further, we will evaluate the short and long-term clinical outcomes after this new procedure.
Primary Outcomes
- Feasibility: successful completion of endoluminal rectal prolapse repair with needlescopic assistance
- Safety: measured by the incidence of the Intraoperative complications (bowel perforation, organ injury and bleeding requiring blood transfusion)
- Sedation and local anesthesia feasibility: surgery completed without patient intubation
- Clinical Outcomes: rectal prolapse recurrence within 30 days, length of hospital stay and postsurgical complications
- Long Term Clinical Outcomes: Rectal Prolapse Recurrence
Methods Design: A prospective pilot study with 10 patients who will be undergoing Combined Needlescopic and Endoluminal (Colonoscopic) Surgery under sedation and local anesthesia for Rectal Prolapse Repair with the Colon and Rectal Surgeons at WCMC. Data will be collected prospectively before, during, and after surgery.
Settings: Colon and Rectal Surgery at WCMC-NYPH Population: Patients male and female above 75 years of age, with rectal prolapse will be invited to participate in the study after surgery is deemed necessary for standard treatment of their medical conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Rectal Prolapse | Other | Procedure: endoluminal rectal prolapse repair under sedationendoluminal rectal prolapse repair under sedation and local anesthesia using CO2 colonoscopy to fix the rectum with sutures to the abdominal wall under needlescopic control. |
Who may qualify
- Ages
- 75 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Age, 75 years and older, Male and Female
- BMI above 18 and ≤30
- ASA class 1-3
- willing to participate in the study
Key exclusion criteria (2 listed)
- ASA class 4-5
- Previous Abdominal Surgeries including abdominal wall repair with mesh
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 |
|---|---|---|
| endoluminal rectal prolapse repair under sedationendoluminal rectal prolapse repair under sedation | Procedure or surgery | Rectal Prolapse |
Primary outcome
rectal prolapse recurrence
Time frame: 12 months
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 30 Jul 2019.
- Derived from this study: PubMed 33090077Milsom JW, Trencheva K, Gadalla F, Abramovitz S, Garrett KA. Rectal Prolapse Repair with Abdominal Fixation Under Sedation and Local or Epidural Anesthesia: Prospective Pilot Study in 10 Elderly Subjects. J Laparoendosc Adv Surg Tech A. 2021 Aug;31(8):911-916. doi: 10.1089/lap.2019.0804. Epub 2020 Oct 21.
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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.
Jeffrey W Milsom, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing endoluminal rectal prolapse repair under sedation in people with Rectal Prolapse, run by Weill Medical College of Cornell University at 1 site in United States.
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 4 inclusion and 2 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 30 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
rectal prolapse recurrence (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01980043, which also lists 1 linked publication.
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 30 Jul 2019.