NCT02901210

Brief Summary

The aim of this study is to evaluate the investigator new modification for delorme procedure in patients with rectal prolapse , assessing intra-operative morbidity and recurrence rate .

Trial Health

100
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2015

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2016

Completed
18 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
Last Updated

September 15, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

July 14, 2016

Last Update Submit

September 10, 2016

Conditions

Rectal Prolapse

Keywords

Recta prolapseIntraoperative bleedingmucosal cauterization

Outcome Measures

Primary Outcomes (2)

  • Recurrence rate assessed in this modified technique

    One year follow up post operative

  • intraoperative bleeding measured in this modified technique

    one year follow up post operative.

Study Arms (1)

Modified Delorme

EXPERIMENTAL

Modified technique for delorme procedure done in mild to moderate rectal prolapse as the investigator destroy use the electrocautery to peal the mucosa with less intraoperative bleeding ,avoiding stripping of the mucosa done in classic delorme that induce major bleeding intraoperative .

Procedure: Modified delorme procedure

Interventions

Modified delorme procedurePROCEDURE
Modified Delorme

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Mild to moderate rectal prolapse
  • Singed informed consent.

You may not qualify if:

  • Huge rectal prolapse .
  • Recurrent rectal prolapse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Rectal ProlapseBlood Loss, Surgical

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesPelvic Organ ProlapseProlapsePathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsHemorrhagePathologic ProcessesIntraoperative Complications

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Lecturer of general surgery.

Study Record Dates

First Submitted

July 14, 2016

First Posted

September 15, 2016

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

August 1, 2016

Last Updated

September 15, 2016

Record last verified: 2016-09