DiverticulitisPhase 4NCT00453830
Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease
A Phase 4 study testing laparoscopic sigmoid resection in people with Diverticulitis, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
Aim: This is a prospective, randomized comparison of traditional open (OS) and laparoscopic sigmoidectomy (LS) in patients with complicated diverticular disease. The study is designed in order to minimize bias by standardizing the two procedures and blinding patients and nurses during the preoperative and early… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Diverticulitis
- What is being tested?
- laparoscopic sigmoid resection
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2005to Feb 2009
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Informed consent
- Diverticular disease of sigmoid colon documented by colonoscopy AND 2 episodes of uncomplicated diverticulitis, one at least being documented with CT scan OR 1 episode of complicated diverticulitis, i.e. perforation, with or without pericolic abscess or pelvic abscess requiring percutaneous drain
Who cannot join
- Age < 18
- Associated colon cancer or any condition requiring extended colectomy
- BMI > 35
- Emergency procedure
- Use of opiates and/or analgesics within 48 hours preceding the surgical procedure
- Patient unable to communicate in French, English or German
- Any cognitive impairment (psychiatric disorder, Alzheimer's disease, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease: A Prospective Randomized Single-Blind Trial
Aim: This is a prospective, randomized comparison of traditional open (OS) and laparoscopic sigmoidectomy (LS) in patients with complicated diverticular disease. The study is designed in order to minimize bias by standardizing the two procedures and blinding patients and nurses during the preoperative and early postoperative period.
Hypothesis: A laparoscopic approach for sigmoidectomy has significant advantages over the open technique with respect to postoperative pain, duration of ileus, length of hospital stay, and perioperative morbidity.
Read more
Methods: Patients with complicated diverticular disease who are candidates for elective sigmoidectomy will be randomized the day before surgery, and anaesthetic technique and postoperative management will be standardized between groups. Surgeons with experience in both laparoscopic-assisted and open colectomy will perform both types of procedures. At the end of the operation, identical, opaque wound dressings will be applied and left in place until postoperative day 4. Both patients and nursing staff will therefore be blinded to the type of surgical technique during the early postoperative period.
Endpoints:
- Postoperative pain assessed by the Visual Analog Scale at postoperative days 1, 2, and 3.
- Postoperative intake of systemic opiates (morphine)
- Duration of postoperative ileus, quantified by the interval in hours between the end of the procedure and passage of first stool.
- Duration of hospital stay.
- Surgical complications, such as wound infection, anastomotic leakage, bleeding
- General medical complications, such as cardiopulmonary, pneumonia, and renal failure.
Rationale: This study will determine whether a laparoscopic sigmoidectomy is associated with significant clinical advantages over the traditional open approach when patients with complicated diverticular disease are blinded to the operative technique.
Read the detailed description
Colonic diverticulosis is an increasingly common condition in the Western societies; in our country, a third of the population is affected by the 6th decade and two-thirds by the 9th decade. Fortunately, a majority of patients with diverticulosis remain asymptomatic; diverticulitis, the most common presentation of complicated diverticular disease, has an estimated incidence of 10 patients per 100,000/year.
Colonic diverticular disease is usually restricted to the sigmoid colon, and conservative treatment with antibiotics is indicated in cases of a first attack of uncomplicated diverticulitis, the rationale being that a majority of patients treated for a first episode of acute inflammation will eventually recover and have no further problems.
Elective sigmoidectomy is currently recommended in the following clinical situations:
- Patients who had two episodes of uncomplicated diverticulitis.
- Patients who had one episode of complicated (perforated) diverticulitis, with either pericolic of pelvic abscesses (Hinchey stage I and II respectively), fistula formation and/or stenosis.
Resection of the sigmoid colon is now commonly performed by laparoscopy, and a number of non-randomized publications have demonstrated that this approach is safe and feasible in patients with diverticular disease. The theoretical advantages of celioscopy over the open techniques include decreased postoperative pain, a shorter duration of postoperative ileus and hospital stay, and improved cosmetic. Surprisingly, however, most published data on the topic are restricted to case-control series, and so far the putative advantages of laparoscopy have not been substantiated through a prospective randomized trial.
- Conditions
- Diverticulitis
- Being tested
- laparoscopic sigmoid resection
- Keywords
- Diverticulitis; laparoscopy; short term outcome
- Medical subject headings
- Diverticulitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic sigmoid resectionProcedure or surgery
Also called laparoscopic-assisted sigmoid resection
a laparoscopic 5 trocars approach for left colon mobilization, sigmoid colon transsection and intracorporeal colorectal anastomosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain at days 1, 2 and 3
Measured: 7 days
Morphine requirements at days 1, 2 and 3
Measured: 4 days
Duration of postoperative ileus
Measured: 10 days
Secondary outcomes (4)
Medical complications
Measured: 30 days
Surgical complications
Measured: 30 days
Duration of surgical procedure
Measured: 1 days
Duration of hospital stay
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2007 (estimated)
- Study startJan 2005
- Primary completionFeb 2009
- Study completionFeb 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiverticulitisStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Philippe Morel, MD, Study chair, University Hospital Geneva - Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00453830
- Sponsor's protocol ID
- CER 04-179
- Status last verified
- Feb 2009
- First submitted
- 28 Mar 2007
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Gervaz P, Mugnier-Konrad B, Morel P, Huber O, Inan I. Laparoscopic versus open sigmoid resection for diverticulitis: long-term results of a prospective, randomized trial. Surg Endosc. 2011 Oct;25(10):3373-8. doi: 10.1007/s00464-011-1728-8. Epub 2011 May 10.
PubMed 21556992Gervaz P, Inan I, Perneger T, Schiffer E, Morel P. A prospective, randomized, single-blind comparison of laparoscopic versus open sigmoid colectomy for diverticulitis. Ann Surg. 2010 Jul;252(1):3-8. doi: 10.1097/SLA.0b013e3181dbb5a5.
PubMed 20505508
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease: A Prospective Randomized Single-Blind Trial
- ClinicalTrials.gov ID
- NCT00453830
- Acronym / sponsor ID
- CER 04-179
- Conditions
- Diverticulitis
- Keywords
- Diverticulitis; laparoscopy; short term outcome
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Jan 2005
- Primary completion
- Feb 2009 (actual)
- Study completion
- Feb 2009 (actual)
- First posted
- 29 Mar 2007 (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.
Aim: This is a prospective, randomized comparison of traditional open (OS) and laparoscopic sigmoidectomy (LS) in patients with complicated diverticular disease. The study is designed in order to minimize bias by standardizing the two procedures and blinding patients and nurses during the preoperative and early postoperative period.
Hypothesis: A laparoscopic approach for sigmoidectomy has significant advantages over the open technique with respect to postoperative pain, duration of ileus, length of hospital stay, and perioperative morbidity.
Methods: Patients with complicated diverticular disease who are candidates for elective sigmoidectomy will be randomized the day before surgery, and anaesthetic technique and postoperative management will be standardized between groups. Surgeons with experience in both laparoscopic-assisted and open colectomy will perform both types of procedures. At the end of the operation, identical, opaque wound dressings will be applied and left in place until postoperative day 4. Both patients and nursing staff will therefore be blinded to the type of surgical technique during the early postoperative period.
Endpoints:
- Postoperative pain assessed by the Visual Analog Scale at postoperative days 1, 2, and 3.
- Postoperative intake of systemic opiates (morphine)
- Duration of postoperative ileus, quantified by the interval in hours between the end of the procedure and passage of first stool.
- Duration of hospital stay.
- Surgical complications, such as wound infection, anastomotic leakage, bleeding
- General medical complications, such as cardiopulmonary, pneumonia, and renal failure.
Rationale: This study will determine whether a laparoscopic sigmoidectomy is associated with significant clinical advantages over the traditional open approach when patients with complicated diverticular disease are blinded to the operative technique.
Detailed description
Colonic diverticulosis is an increasingly common condition in the Western societies; in our country, a third of the population is affected by the 6th decade and two-thirds by the 9th decade. Fortunately, a majority of patients with diverticulosis remain asymptomatic; diverticulitis, the most common presentation of complicated diverticular disease, has an estimated incidence of 10 patients per 100,000/year.
Colonic diverticular disease is usually restricted to the sigmoid colon, and conservative treatment with antibiotics is indicated in cases of a first attack of uncomplicated diverticulitis, the rationale being that a majority of patients treated for a first episode of acute inflammation will eventually recover and have no further problems.
Elective sigmoidectomy is currently recommended in the following clinical situations:
- Patients who had two episodes of uncomplicated diverticulitis.
- Patients who had one episode of complicated (perforated) diverticulitis, with either pericolic of pelvic abscesses (Hinchey stage I and II respectively), fistula formation and/or stenosis.
Resection of the sigmoid colon is now commonly performed by laparoscopy, and a number of non-randomized publications have demonstrated that this approach is safe and feasible in patients with diverticular disease. The theoretical advantages of celioscopy over the open techniques include decreased postoperative pain, a shorter duration of postoperative ileus and hospital stay, and improved cosmetic. Surprisingly, however, most published data on the topic are restricted to case-control series, and so far the putative advantages of laparoscopy have not been substantiated through a prospective randomized trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Informed consent
- Diverticular disease of sigmoid colon documented by colonoscopy AND 2 episodes of uncomplicated diverticulitis, one at least being documented with CT scan OR 1 episode of complicated diverticulitis, i.e. perforation, with or without pericolic abscess or pelvic abscess requiring percutaneous drain
Key exclusion criteria (7 listed)
- Age < 18
- Associated colon cancer or any condition requiring extended colectomy
- BMI > 35
- Emergency procedure
- Use of opiates and/or analgesics within 48 hours preceding the surgical procedure
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 sigmoid resectionAlso: laparoscopic-assisted sigmoid resectiona laparoscopic 5 trocars approach for left colon mobilization, sigmoid colon transsection and intracorporeal colorectal anastomosis | Procedure or surgery | – |
Primary outcome
Postoperative pain at days 1, 2 and 3
Time frame: 7 days
Morphine requirements at days 1, 2 and 3
Time frame: 4 days
Duration of postoperative ileus
Time frame: 10 days
4 secondary outcomes
Medical complications
Time frame: 30 days
Surgical complications
Time frame: 30 days
Duration of surgical procedure
Time frame: 1 days
Duration of hospital stay
Time frame: 2 months
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 18 Feb 2009.
- Derived from this study: PubMed 21556992Gervaz P, Mugnier-Konrad B, Morel P, Huber O, Inan I. Laparoscopic versus open sigmoid resection for diverticulitis: long-term results of a prospective, randomized trial. Surg Endosc. 2011 Oct;25(10):3373-8. doi: 10.1007/s00464-011-1728-8. Epub 2011 May 10.
- Derived from this study: PubMed 20505508Gervaz P, Inan I, Perneger T, Schiffer E, Morel P. A prospective, randomized, single-blind comparison of laparoscopic versus open sigmoid colectomy for diverticulitis. Ann Surg. 2010 Jul;252(1):3-8. doi: 10.1097/SLA.0b013e3181dbb5a5.
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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.
Philippe Morel, MD study chair
University Hospital Geneva - Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing laparoscopic sigmoid resection in people with Diverticulitis, run by University Hospital, Geneva 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 7 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 18 Feb 2009. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Postoperative pain at days 1, 2 and 3 (time frame: 7 days). The study lists 3 primary outcomes in all. 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 NCT00453830, which also lists 2 linked publications.
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 18 Feb 2009.