Diverticular DiseaseNCT02500992
Bacterial Contamination in Transrectal Hybrid NOTES Sigmoidectomy
An observational study of Diverticular Disease, run by Cantonal Hospital, Baselland at 1 site in Switzerland.
Trial summary
Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained popularity. It is an appealing technique as a minilaparotomy in order to retrieve the specimen is avoided. Therefore less postoperative pain and a better cosmetic result are expected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diverticular Disease
- What is being tested?
- Transrectal sigmoidectomy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jul 2015to Jul 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with an indication for elective sigmoidectomy for diverticular disease. Status post several episodes of diverticulitis, status post contained diverticulitis.
Who may be able to join
- Status post several episodes of diverticulitis
- Status post contained diverticulitis
Who cannot join
- not able to give informed consent
- <18 years of age
- pregnancy
- emergency operation
- acute diverticulitis
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Baselland Bruderholz
Bruderholz, 4101
Daniel C Steinemann, MD, daniel.steinemann@ksbl.ch
Sebastian Lamm, MD, sebastian.lamm@ksbl.ch
About this study
Official title: Bacterial Contamination in Transrectal Hybrid Natural Orifice Translumenal Endoscopic Surgery Sigmoidectomy for Diverticular Disease
Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained popularity. It is an appealing technique as a minilaparotomy in order to retrieve the specimen is avoided. Therefore less postoperative pain and a better cosmetic result are expected. The feasibility of the technique has been demonstrated.
Still an open question is the risk of intraperitoneal contamination as in this procedure the colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in order to fashion an anastomosis.
In this study the bacterial contamination in the rectal stump as well as in the peritoneal cavity is assessed. The results are compared to bacteriological samples taken in a comparison group consisting of conventional laparoscopic assisted sigmoidectomies.
- Conditions
- Diverticular Disease
- Being tested
- Transrectal sigmoidectomy
- Medical subject headings
- Diverticular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transrectal sigmoidectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Transrectal sigmoidectomy | Patients undergoing transrectal NOTES sigmoidectomy Receives: Procedure: Transrectal sigmoidectomy | |
| Laparoscopic-assisted sigmoidectomy | Patients undergoing laparoscopic-assisted sigmoidectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peritoneal bacterial contamination
microbacteriological swabs
Measured: during surgery
Contamination in the rectal stump after wash-out
Measured: during surgery
Secondary outcomes (1)
septic complications
Measured: within 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2015 (estimated)
- Study startJul 2015
- Primary completionJul 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diverticular DiseaseStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital, Baselland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Steinemann, MD, Cantonal Hospital, Baselland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02500992
- Sponsor's protocol ID
- NoBakt transrectal
- Status last verified
- Jul 2015
- First submitted
- 15 Jul 2015
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacterial Contamination in Transrectal Hybrid Natural Orifice Translumenal Endoscopic Surgery Sigmoidectomy for Diverticular Disease
- ClinicalTrials.gov ID
- NCT02500992
- Acronym / sponsor ID
- NoBakt transrectal
- Conditions
- Diverticular Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Cantonal Hospital, BasellandUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jul 2016 (estimated)
- First posted
- 17 Jul 2015 (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.
Transrectal Hybrid natural orifice translumenal endoscopic surgery sigmoidectomy has gained popularity. It is an appealing technique as a minilaparotomy in order to retrieve the specimen is avoided. Therefore less postoperative pain and a better cosmetic result are expected. The feasibility of the technique has been demonstrated.
Still an open question is the risk of intraperitoneal contamination as in this procedure the colon has to be opened. This is the case for (a) retrieval of the specimen thru the opened rectal stump and (b) for intracorporeal insertion of the anvil of the circular stapler in order to fashion an anastomosis.
In this study the bacterial contamination in the rectal stump as well as in the peritoneal cavity is assessed. The results are compared to bacteriological samples taken in a comparison group consisting of conventional laparoscopic assisted sigmoidectomies.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transrectal sigmoidectomy | – | Procedure: Transrectal sigmoidectomyPatients undergoing transrectal NOTES sigmoidectomy |
| Laparoscopic-assisted sigmoidectomy | – | –Patients undergoing laparoscopic-assisted sigmoidectomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with an indication for elective sigmoidectomy for diverticular disease. Status post several episodes of diverticulitis, status post contained diverticulitis.
Key inclusion criteria (2 listed)
- Status post several episodes of diverticulitis
- Status post contained diverticulitis
Key exclusion criteria (5 listed)
- not able to give informed consent
- <18 years of age
- pregnancy
- emergency operation
- acute diverticulitis
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 |
|---|---|---|
| Transrectal sigmoidectomy | Procedure or surgery | Transrectal sigmoidectomy |
Primary outcome
Peritoneal bacterial contamination
Time frame: during surgery
microbacteriological swabs
Contamination in the rectal stump after wash-out
Time frame: during surgery
1 secondary outcome
septic complications
Time frame: within 30 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2015.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diverticular Disease, run by Cantonal Hospital, Baselland at 1 site in Switzerland.
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 2 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 17 Jul 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Daniel C Steinemann, MD (41 61 436 27 04, daniel.steinemann@ksbl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peritoneal bacterial contamination (time frame: during surgery). The study lists 2 primary outcomes in all. 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 17 Jul 2015.