Symptomatic Recurrent Diverticular DiseasePhase 2LATANCT01033838
Randomized Trial Comparing Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Transrectal Specimen Retrieval
A Phase 2 study testing rectosigmoid resection in people with Symptomatic Recurrent Diverticular Disease and Benign Adenomatous Sigmoidal Polyp, Requiring Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. Most patients can be included within a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Symptomatic Recurrent Diverticular Disease, Benign Adenomatous Sigmoidal Polyp, Requiring Surgery, Early Non-transmural Sigmoidtumor
- What is being tested?
- rectosigmoid resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteBelgium
- Study dates
- Dec 2009to 1 Jun 2025
- Phase
- Phase 2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-90
- Symptomatic recurrent diverticular disease
- Benign adenomatous polyp, requiring surgery
- Early non-transmural sigmoidtumor
- Signed written informed consent, approved by ethical committee
Who cannot join
- Patients unsuitable for laparoscopy
- Pregnancy
- ASA >III
- Coagulation disorders
- Anti-coagulants
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospitals Leuven
Leuven, 3000
Albert M Wolthuis, MD
About this study
Official title: Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval
Laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. Most patients can be included within a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the specimen is retrieved within an endobag through the rectum. The anastomosis is created intracorporeally using a triple stapled technique. There are no trials available in the literature concerning these 2 techniques. Therefore this study will be undertaken to establish the role of the 2 surgical procedures and to compare them after short-term follow-up.
- Conditions
- Symptomatic Recurrent Diverticular Disease, Benign Adenomatous Sigmoidal Polyp, Requiring Surgery, Early Non-transmural Sigmoidtumor
- Being tested
- rectosigmoid resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
rectosigmoid resectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| laparoscopic-assisted rectosigmoid resection | Active comparator | Not described Receives: Procedure: rectosigmoid resection |
| laparoscopic rectosigmoid resection and transrectal retrieval | Experimental | Not described Receives: Procedure: rectosigmoid resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in analgetic need
Secondary outcomes (5)
reduction in hospital stay within an ERAS-program
effect on the inflammatory response
effect on anal continence
procedural cost assessment (incorporating operative time)
overall cost assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2011
- Study completion1 Jun 2025 (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 Symptomatic Recurrent Diverticular DiseaseStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 1 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01033838
- Sponsor's protocol ID
- S51801-B32220097328
- Acronym
- LATA
- Status last verified
- Jun 2024
- First submitted
- 16 Dec 2009
- Last updated
- 1 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
Publications
Wolthuis AM, Fieuws S, Van Den Bosch A, de Buck van Overstraeten A, D'Hoore A. Randomized clinical trial of laparoscopic colectomy with or without natural-orifice specimen extraction. Br J Surg. 2015 May;102(6):630-7. doi: 10.1002/bjs.9757. Epub 2015 Mar 12.
PubMed 25764376
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conventional Laparoscopic-assisted Rectosigmoid Resection Versus Laparoscopic Rectosigmoid Resection With Intracorporeal Anastomosis and Transrectal Specimen Retrieval
- ClinicalTrials.gov ID
- NCT01033838
- Acronym / sponsor ID
- LATA / S51801-B32220097328
- Conditions
- Symptomatic Recurrent Diverticular Disease, Benign Adenomatous Sigmoidal Polyp, Requiring Surgery, Early Non-transmural Sigmoidtumor
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- 1 Jun 2025 (estimated)
- First posted
- 17 Dec 2009 (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.
Laparoscopic anterior resection is a standardized procedure requiring a small muscle split incision to retrieve the specimen and to fashion the proximal part of the double stapled anastomosis. Most patients can be included within a standardized perioperative care program called Enhanced Recovery After Surgery (ERAS). A new evolution as a primary step towards a complete Natural Orifice Translumenal Endoscopic Surgery (NOTES)-procedure is a hybrid approach (transrectal and laparoscopic). The dissection is performed laparoscopically but the specimen is retrieved within an endobag through the rectum. The anastomosis is created intracorporeally using a triple stapled technique. There are no trials available in the literature concerning these 2 techniques. Therefore this study will be undertaken to establish the role of the 2 surgical procedures and to compare them after short-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| laparoscopic-assisted rectosigmoid resection | Active comparator | Procedure: rectosigmoid resection |
| laparoscopic rectosigmoid resection and transrectal retrieval | Experimental | Procedure: rectosigmoid resection |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age 18-90
- Symptomatic recurrent diverticular disease
- Benign adenomatous polyp, requiring surgery
- Early non-transmural sigmoidtumor
- Signed written informed consent, approved by ethical committee
Key exclusion criteria (5 listed)
- Patients unsuitable for laparoscopy
- Pregnancy
- ASA >III
- Coagulation disorders
- Anti-coagulants
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 |
|---|---|---|
| rectosigmoid resection | Procedure or surgery | laparoscopic rectosigmoid resection and transrectal retrieval, laparoscopic-assisted rectosigmoid resection |
Primary outcome
Reduction in analgetic need
5 secondary outcomes
reduction in hospital stay within an ERAS-program
effect on the inflammatory response
effect on anal continence
procedural cost assessment (incorporating operative time)
overall cost assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2024.
- Derived from this study: PubMed 25764376Wolthuis AM, Fieuws S, Van Den Bosch A, de Buck van Overstraeten A, D'Hoore A. Randomized clinical trial of laparoscopic colectomy with or without natural-orifice specimen extraction. Br J Surg. 2015 May;102(6):630-7. doi: 10.1002/bjs.9757. Epub 2015 Mar 12.
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?
A Phase 2 study testing rectosigmoid resection in people with Symptomatic Recurrent Diverticular Disease and Benign Adenomatous Sigmoidal Polyp, Requiring Surgery, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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 5 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 1 Jul 2024. 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 Belgium. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Albert M Wolthuis, MD (+3216344265, albert.wolthuis@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in analgetic need. 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 NCT01033838, 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 1 Jul 2024.