Sigmoid Diverticulitis (Hinchey I and II)NCT01043731
Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection
An observational study of Sigmoid Diverticulitis (Hinchey I and II) and Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis, run by Cantonal Hospital of St. Gallen at 1 site in Switzerland.
Trial summary
Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Sigmoid Diverticulitis (Hinchey I and II), Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis
- What is being tested?
- Laparoscopic transvaginal hybrid anterior resection
- Type of treatment
- Surgery or procedure
- How many people
- 45 participants
- Where
- 1 siteSwitzerland
- Study dates
- Sep 2008to Nov 2010
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Given indication for laparoscopic anterior resection
Who may be able to join
- given informed consent
- sigmoid diverticulosis (two or more attacks)
- sigmoid diverticulitis (Hinchey I and II)
Who cannot join
- ASA IV
- emergency surgery
- liver-malfunction or coagulation disorders
- acute diverticulitis (Hinchey III and IV)
- malignancy
- acute vaginal infection
Show all 12Show fewer
- refusal of mandatory preoperative gynecological examination
- pregnancy
- endometriosis
- previous surgery of colon and rectum
- strongly retroflexed uterus
- acute pelvic disorders, infection
Trial locations and contacts
1 site in 1 country.
About this study
Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. The aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine.
Therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.
- Conditions
- Sigmoid Diverticulitis (Hinchey I and II), Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis
- Being tested
- Laparoscopic transvaginal hybrid anterior resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic transvaginal hybrid anterior resectionProcedure or surgery
Transvaginal Hybrid Anterior Resection: three 5mm trocars are placed transabdominally (one trans-umbilical, the other two in the lower abdomen). Identification of the inferior mesenteric vein and artery. Clipping of the vein. Then placement of a 12mm trocar through the posterior fornix of the vagina for stapling of the inferior mesenteric artery. After mobilisation of the colon descendens and the splenic flexure stapling of the proximal rectum through the 12mm trocar placed vaginally. Afterwards the colpotomy is performed and the mobilised left hemi-colon is extracted transvaginally. The proximal colonic resection is performed extracorporeally in the conventional fashion with placement of a purse-string suture and insertion of the circular stapling anvil into the proximal end of the bowel. The bowel is then replaced into the abdominal cavity. The colpotomy is then closed. A circular stapler is inserted transanally and the end-to-end anastomosis is performed.
| Study group | Role | What they receive |
|---|---|---|
| Ginven indication for laparoscopic anterior resection | Not described Receives: Procedure: Laparoscopic transvaginal hybrid anterior resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and safety of the transvaginal operation
Measured: 30 days
Secondary outcomes (1)
Long-term life quality and sexual dysfunction
Measured: 3 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2010 (estimated)
- Study startSep 2008
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sigmoid Diverticulitis (Hinchey I and II)Studies 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
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cantonal Hospital of St. Gallen
- Sponsor type
- University, hospital or other
- Investigators
- Andreas Zerz, MD, Principal investigator, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01043731
- Sponsor's protocol ID
- EKSG09/151/2B
- Status last verified
- Jul 2010
- First submitted
- 6 Jan 2010
- Last updated
- 10 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Transvaginal Hybrid Anterior Resection: a Prospective Data Collection
- ClinicalTrials.gov ID
- NCT01043731
- Acronym / sponsor ID
- EKSG09/151/2B
- Conditions
- Sigmoid Diverticulitis (Hinchey I and II), Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Cantonal Hospital of St. GallenUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 7 Jan 2010 (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.
Transvaginal hybrid procedures are of interest as an available NOTES-Procedure for the clinical routine. Few authors have demonstrated the feasibility and safety of such procedures (e.g. cholecystectomy) in selected patient collectives. In 2008 Lacy at al. published the experience with a transvaginal sigmoidectomy as a first in human report. The aim of this prospective data collection is to evaluate the feasibility and safety of the transvaginal hybrid anterior resection in the clinical routine.
Therefore all patients giving the informed consent to the transvaginal hybrid anterior resection will be included and assessed concerning feasibility to perform the transvaginal approach and complete the operation transvaginally.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ginven indication for laparoscopic anterior resection | – | Procedure: Laparoscopic transvaginal hybrid anterior resection |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Given indication for laparoscopic anterior resection
Key inclusion criteria (3 listed)
- given informed consent
- sigmoid diverticulosis (two or more attacks)
- sigmoid diverticulitis (Hinchey I and II)
Key exclusion criteria (12 listed)
- ASA IV
- emergency surgery
- liver-malfunction or coagulation disorders
- acute diverticulitis (Hinchey III and IV)
- malignancy
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 |
|---|---|---|
| Laparoscopic transvaginal hybrid anterior resectionTransvaginal Hybrid Anterior Resection: three 5mm trocars are placed transabdominally (one trans-umbilical, the other two in the lower abdomen). Identification of the inferior mesenteric vein and artery. Clipping of the vein. Then placement of a 12mm trocar through the posterior fornix of the vagina for stapling of the inferior mesenteric artery. After mobilisation of the colon descendens and the splenic flexure stapling of the proximal rectum through the 12mm trocar placed vaginally. Afterwards the colpotomy is performed and the mobilised left hemi-colon is extracted transvaginally. The proximal colonic resection is performed extracorporeally in the conventional fashion with placement of a purse-string suture and insertion of the circular stapling anvil into the proximal end of the bowel. The bowel is then replaced into the abdominal cavity. The colpotomy is then closed. A circular stapler is inserted transanally and the end-to-end anastomosis is performed. | Procedure or surgery | Ginven indication for laparoscopic anterior resection |
Primary outcome
Feasibility and safety of the transvaginal operation
Time frame: 30 days
1 secondary outcome
Long-term life quality and sexual dysfunction
Time frame: 3 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 10 Dec 2010.
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 principal investigator
Cantonal Hospital of St. Gallen
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 Diverticulitis (Hinchey I and II) and Sigmoid Diverticulosis With Two or More Attacks of Diverticulitis, run by Cantonal Hospital of St. Gallen 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 3 inclusion and 12 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 10 Dec 2010. 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?
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?
Feasibility and safety of the transvaginal operation (time frame: 30 days). 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 10 Dec 2010; AzTrials last refreshed its copy on 6 Nov 2026.