A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection

July 27, 2013 updated by: Wang Shaochuan, First Affiliated Hospital, Sun Yat-Sen University
To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.Both of the two kinds of surgery is conventional,but the comparison is still unclear.The investigators divide the patients into two groups, and compare the differences of postoperative outcomes by statistics.

Study Type

Observational

Enrollment (Actual)

1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Inpatients

Description

Inclusion Criteria:

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

Exclusion Criteria:

without endometriosis rectum,

history of colorectal surgery,

intolerance to laparoscopic surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
transabdominal laparoscope surgery
transvaginal laparoscopic surgery
Procedure: transvaginal laparoscopic surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rectovaginal fistula
Time Frame: one year
number of participants
one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative constipation
Time Frame: one year
number of patients
one year
postoperative uroschesis
Time Frame: one year
number of patients
one year
intestinal obstruction
Time Frame: one year
number of patients
one year
surgical wound infection
Time Frame: one year
number of patients
one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
dyspareunia
Time Frame: one year
number of patients
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital, Sun Yat-Sen University

Investigators

  • Study Director: Yao Shuzhong, MD, First Affiliated Hospital of Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

July 23, 2013

First Submitted That Met QC Criteria

July 27, 2013

First Posted (Estimate)

July 30, 2013

Study Record Updates

Last Update Posted (Estimate)

July 30, 2013

Last Update Submitted That Met QC Criteria

July 27, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • nova-0425

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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