NCT03643393

Brief 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. A literature review was performed to determine optimal management of incarcerated and necrotic rectal prolapse, and to determine the indication for fecal diversion.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2015

Typical duration for not_applicable

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 1, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2018

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 31, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
Last Updated

August 22, 2018

Status Verified

August 1, 2018

Enrollment Period

3.2 years

First QC Date

July 31, 2018

Last Update Submit

August 20, 2018

Conditions

Rectal Prolapse

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months after surgery

Study Arms (1)

incarceration rectal prolapse

OTHER
Procedure: perineal rectosigmoidectomy

Interventions

perineal rectosigmoidectomyPROCEDURE

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.

Also known as: Altemeier's procedure
incarceration rectal prolapse

Eligibility Criteria

Age52 Years - 69 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • cases incarceration rectalprolapse

You may not qualify if:

  • N/A

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal Prolapse

Condition Hierarchy (Ancestors)

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

Study Officials

  • xuan hung nguyen, DR

    center of colorectal surgery - viet duc university hospital

    STUDY CHAIR

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

July 31, 2018

First Posted

August 22, 2018

Study Start

May 1, 2015

Primary Completion

June 30, 2018

Study Completion

June 30, 2018

Last Updated

August 22, 2018

Record last verified: 2018-08