Sigmoid DiverticulosisNCT01992406
Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection
An observational study of Sigmoid Diverticulosis and Sigmoid Diverticulitis, run by Cantonal Hospital, Baselland at 1 site in Switzerland.
Trial summary
Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sigmoid Diverticulosis, Sigmoid Diverticulitis, Colon Adenoma
- How many people
- 60 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2013to Nov 2016
- How long will I take part?
- 6 Months
- 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 benign indication for left sided colectomy
Who may be able to join
- benign indication for left sided colectomy
Who cannot join
- age below 18 years
- unable to understand informed consent of missing informed consent
- emergency surgery
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital Baselland, Department of Surgery, Bruderholz
Bruderholz, 4101
Daniel C Steinemann, MD
Sebastian Lamm, MD
About this study
Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transvaginal laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that such NOTES procedures are feasible and safe. The complication rate to conventional laparoscopic procedures is similar. Since transvaginal access is impossible in men, an alternative route is missing. There are experimental studies and small case series reporting the feasibility of transrectal anterior resection. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transrectal hybrid-NOTES anterior resection.
Read the detailed description
Primary endpoint:
To demonstrate in a prospective cohort study the feasibility (specimen extraction through rectum possible to perform or not), safety (complications graded according to Clavien-Dindo) and postoperative outcome (gastrointestinal quality of life questionnaire and anal sphincter manometry) of routine hybrid-NOTES transrectal anterior resection for benign indication in men and women.
Secondary endpoints:
- quality of life 6 months after surgery
- continence 6 months after surgery
- pain postoperative
- complication rate
- duration of procedure
- lengh of stay
Hypothesis:
The investigators expect specimen extraction through the rectum to be feasible in 80% of cases (in the others an alternative mini-laparotomy has to be performed).
study design: This is an open cohort study on 60 patients. The patients are included before surgery and baseline parameters are put in a registry. There are clinical controls 6 weeks, 3 and 6 months postoperative. 3 and 6 months postoperative as well as preoperative a anorectal manometry is performed.
Inclusion criteria:
- benign indication for left sided colectomy. exclusion criteria:
- age <18 years
- patient unable to understand informed consent or missing informed consent
- emergency surgery power calculation: A feasibility of 80% with a precision of 15% is estimated. Given a 5% drop out rate 36 patients are to be included in the study.
- Medical subject headings
- Rectal Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Transrectal hybrid-NOTES anterior resection | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transanal specimen extraction possible or not
Feasibility to remove the specimen (sigmoid colon) through the rectum/anus. If this is not possible during surgery (due to bulky specimen or narrow pelvis) an alternative mini-laparotomy has to be performed.
Measured: at surgery
Secondary outcomes (3)
Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo)
Postoperative complications are recorded and graded according to Clavien-Dindo classification. Complication rates and especially occurence of anastomotic leakage and pelvic sepsis will be compared to the literature of current techniques.
Measured: up to 6 weeks postoperative
continence 6 months postoperative
Measured: 6 months postoperative
quality of life
Measured: 6 months postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionNov 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sigmoid DiverticulosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital, Baselland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daniel Steinemann, MD, Cantonal Hospital, Baselland
- Investigators
- Andreas Zerz, MD, Study chair, Kantonsspital Baselland, Department of Surgery, Bruderholz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992406
- Sponsor's protocol ID
- TRANSRECTAL
- Status last verified
- Jul 2015
- First submitted
- 12 Nov 2013
- Last updated
- 17 Jul 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Steinemann DC, Zerz A, Germann S, Lamm SH. Anorectal Function and Quality of Life after Transrectal Rigid-Hybrid Natural Orifice Translumenal Endoscopic Sigmoidectomy. J Am Coll Surg. 2016 Aug;223(2):299-307. doi: 10.1016/j.jamcollsurg.2016.04.002. Epub 2016 Apr 13.
PubMed 27086090
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
- Feasibility, Safety and Outcome of Transrectal Hybrid-NOTES Anterior Resection
- ClinicalTrials.gov ID
- NCT01992406
- Acronym / sponsor ID
- TRANSRECTAL
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cantonal Hospital, BasellandUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Nov 2016 (estimated)
- First posted
- 25 Nov 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.
Natural orifice transluminal endoscopic surgery has become an important topic. NOTES access routes give the opportunity to reduce surgical access trauma leading to a more painless surgery and enhancing a fast postoperative recovery. Experience with transvaginal laparoscopic cholecystectomy and transvaginal anterior resection for diverticulitis show that such NOTES procedures are feasible and safe. The complication rate to conventional laparoscopic procedures is similar. Since transvaginal access is impossible in men, an alternative route is missing. There are experimental studies and small case series reporting the feasibility of transrectal anterior resection. However any prospective feasibility study demonstrating the safety of the procedure and functional outcomes (sphincter function) are missing. This study investigates the feasibility, practicability, safety and subjective as well as functional outcome of transrectal hybrid-NOTES anterior resection.
Detailed description
Primary endpoint:
To demonstrate in a prospective cohort study the feasibility (specimen extraction through rectum possible to perform or not), safety (complications graded according to Clavien-Dindo) and postoperative outcome (gastrointestinal quality of life questionnaire and anal sphincter manometry) of routine hybrid-NOTES transrectal anterior resection for benign indication in men and women.
Secondary endpoints:
- quality of life 6 months after surgery
- continence 6 months after surgery
- pain postoperative
- complication rate
- duration of procedure
- lengh of stay
Hypothesis:
The investigators expect specimen extraction through the rectum to be feasible in 80% of cases (in the others an alternative mini-laparotomy has to be performed).
study design: This is an open cohort study on 60 patients. The patients are included before surgery and baseline parameters are put in a registry. There are clinical controls 6 weeks, 3 and 6 months postoperative. 3 and 6 months postoperative as well as preoperative a anorectal manometry is performed.
Inclusion criteria:
- benign indication for left sided colectomy. exclusion criteria:
- age <18 years
- patient unable to understand informed consent or missing informed consent
- emergency surgery power calculation: A feasibility of 80% with a precision of 15% is estimated. Given a 5% drop out rate 36 patients are to be included in the study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Transrectal hybrid-NOTES anterior resection | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with benign indication for left sided colectomy
Key inclusion criteria (1 listed)
- benign indication for left sided colectomy
Key exclusion criteria (3 listed)
- age below 18 years
- unable to understand informed consent of missing informed consent
- emergency surgery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Transanal specimen extraction possible or not
Time frame: at surgery
Feasibility to remove the specimen (sigmoid colon) through the rectum/anus. If this is not possible during surgery (due to bulky specimen or narrow pelvis) an alternative mini-laparotomy has to be performed.
3 secondary outcomes
Number of Participants with postoperative complications (and severity of complications according Clavien-Dindo)
Time frame: up to 6 weeks postoperative
continence 6 months postoperative
Time frame: 6 months postoperative
quality of life
Time frame: 6 months postoperative
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.
- Derived from this study: PubMed 27086090Steinemann DC, Zerz A, Germann S, Lamm SH. Anorectal Function and Quality of Life after Transrectal Rigid-Hybrid Natural Orifice Translumenal Endoscopic Sigmoidectomy. J Am Coll Surg. 2016 Aug;223(2):299-307. doi: 10.1016/j.jamcollsurg.2016.04.002. Epub 2016 Apr 13.
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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.
Andreas Zerz, MD study chair
Kantonsspital Baselland, Department of Surgery, Bruderholz
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 Sigmoid Diverticulosis and Sigmoid Diverticulitis, 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 1 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: 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 36 36, daniel.steinemann@ksbl.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transanal specimen extraction possible or not (time frame: at surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01992406, which also lists 1 linked publication.
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.