NCT01911962

Brief Summary

To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2011

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

January 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

July 23, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 30, 2013

Completed
Last Updated

July 30, 2013

Status Verified

July 1, 2013

Enrollment Period

1.1 years

First QC Date

July 23, 2013

Last Update Submit

July 27, 2013

Conditions

Colon Rectal Resection

Outcome Measures

Primary Outcomes (1)

  • rectovaginal fistula

    number of participants

    one year

Secondary Outcomes (4)

  • postoperative constipation

    one year

  • postoperative uroschesis

    one year

  • intestinal obstruction

    one year

  • surgical wound infection

    one year

Other Outcomes (1)

  • dyspareunia

    one year

Study Arms (2)

transabdominal laparoscope surgery

transabdominal laparoscope surgery

transvaginal laparoscopic surgery

transvaginal laparoscopic surgery

Procedure: transvaginal laparoscopic surgery

Interventions

transvaginal laparoscopic surgeryPROCEDURE
transvaginal laparoscopic surgery

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Inpatients

You may qualify if:

  • Childbearing age women,
  • older than 18 years,
  • diagnosed with intestinal endometriosis,
  • rectum clinical symptoms for invalid medical treatment,
  • dysmenorrhea, dyspareunia dyschezia, infertility, defecate carries blood,
  • endometriosis in the lower rectum by intraoperative judgment

You may not qualify if:

  • without endometriosis rectum,
  • history of colorectal surgery,
  • intolerance to laparoscopic surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Yao Shuzhong, MD

    First Affiliated Hospital of Sun Yat-sen University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate

Study Record Dates

First Submitted

July 23, 2013

First Posted

July 30, 2013

Study Start

January 1, 2011

Primary Completion

February 1, 2012

Study Completion

June 1, 2012

Last Updated

July 30, 2013

Record last verified: 2013-07