Colon Rectal ResectionNCT01911962
A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection
An observational study of Colon Rectal Resection, run by First Affiliated Hospital, Sun Yat-Sen University.
Trial summary
To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Colon Rectal Resection
- What is being tested?
- transvaginal laparoscopic surgery
- Type of treatment
- Surgery or procedure
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Inpatients
Who may be able to join
- 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
Who cannot join
- without endometriosis rectum,
- history of colorectal surgery,
- intolerance to laparoscopic surgery
About this study
To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.
Read the 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.
- Conditions
- Colon Rectal Resection
- Being tested
- transvaginal laparoscopic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
transvaginal laparoscopic surgeryProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| transabdominal laparoscope surgery | transabdominal laparoscope surgery | |
| transvaginal laparoscopic surgery | transvaginal laparoscopic surgery Receives: Procedure: transvaginal laparoscopic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
rectovaginal fistula
number of participants
Measured: one year
Secondary outcomes (4)
postoperative constipation
number of patients
Measured: one year
postoperative uroschesis
number of patients
Measured: one year
intestinal obstruction
number of patients
Measured: one year
surgical wound infection
number of patients
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startJan 2011
- Primary completionFeb 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colon Rectal ResectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Shaochuan, First Affiliated Hospital, Sun Yat-Sen University
- Investigators
- Yao Shuzhong, MD, Study director, First Affiliated Hospital of Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911962
- Sponsor's protocol ID
- nova-0425
- Status last verified
- Jul 2013
- First submitted
- 23 Jul 2013
- Last updated
- 30 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Study of Natural Orifice Medium-low Rectal Endometriosis Resection
- ClinicalTrials.gov ID
- NCT01911962
- Acronym / sponsor ID
- nova-0425
- Conditions
- Colon Rectal Resection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- First Affiliated Hospital, Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Feb 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 30 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate the postoperative outcome of low medium-low rectal endometriosis: Natural orifice surgery VS transabdominal surgery.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| transabdominal laparoscope surgery | – | –transabdominal laparoscope surgery |
| transvaginal laparoscopic surgery | – | Procedure: transvaginal laparoscopic surgerytransvaginal laparoscopic surgery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Inpatients
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (3 listed)
- without endometriosis rectum,
- history of colorectal surgery,
- intolerance to laparoscopic surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| transvaginal laparoscopic surgery | Procedure or surgery | transvaginal laparoscopic surgery |
Primary outcome
rectovaginal fistula
Time frame: one year
number of participants
4 secondary outcomes
postoperative constipation
Time frame: one year
postoperative uroschesis
Time frame: one year
intestinal obstruction
Time frame: one year
surgical wound infection
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yao Shuzhong, MD study director
First Affiliated Hospital of Sun Yat-sen University
Questions about this trial
What is this clinical trial studying?
An observational study of Colon Rectal Resection, run by First Affiliated Hospital, Sun Yat-Sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rectovaginal fistula (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2013.