NCT01980043

Brief 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. Further, investigators will evaluate the short and long-term clinical outcomes after this novel approach to treating rectal prolapse.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 1, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 8, 2013

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2018

Completed
Last Updated

July 30, 2019

Status Verified

July 1, 2019

Enrollment Period

4.8 years

First QC Date

November 1, 2013

Last Update Submit

July 26, 2019

Conditions

Rectal Prolapse

Outcome Measures

Primary Outcomes (1)

  • rectal prolapse recurrence

    12 months

Study Arms (1)

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.

Procedure: endoluminal rectal prolapse repair under sedation

Interventions

endoluminal rectal prolapse repair under sedationPROCEDURE

endoluminal rectal prolapse repair under sedation

Rectal Prolapse

Eligibility Criteria

Age75 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Age, 75 years and older, Male and Female
  • BMI above 18 and ≤30
  • ASA class 1-3
  • willing to participate in the study

You may not qualify if:

  • ASA class 4-5
  • Previous Abdominal Surgeries including abdominal wall repair with mesh

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical Center- NYPH

New York, New York, 10065, United States

Location

Related Publications (1)

  • 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.

    PMID: 33090077DERIVED

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Jeffrey W Milsom, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 1, 2013

First Posted

November 8, 2013

Study Start

May 20, 2013

Primary Completion

March 22, 2018

Study Completion

March 22, 2018

Last Updated

July 30, 2019

Record last verified: 2019-07

Locations

US(1)