Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease
Primary Purpose
Diverticulitis
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
laparoscopic sigmoid resection
Sponsored by
About this trial
This is an interventional treatment trial for Diverticulitis focused on measuring Diverticulitis; laparoscopy; short term outcome
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.)
Sites / Locations
- Department of Surgery
Outcomes
Primary Outcome Measures
Postoperative pain at days 1, 2 and 3
Morphine requirements at days 1, 2 and 3
Duration of postoperative ileus
Secondary Outcome Measures
Medical complications
Surgical complications
Duration of surgical procedure
Duration of hospital stay
Full Information
NCT ID
NCT00453830
First Posted
March 28, 2007
Last Updated
February 17, 2009
Sponsor
University Hospital, Geneva
1. Study Identification
Unique Protocol Identification Number
NCT00453830
Brief Title
Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease
Official Title
Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease: A Prospective Randomized Single-Blind Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2009
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
February 2009 (Actual)
Study Completion Date
February 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University Hospital, Geneva
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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:
A) Postoperative pain assessed by the Visual Analog Scale at postoperative days 1, 2, and 3.
B) Postoperative intake of systemic opiates (morphine)
C) Duration of postoperative ileus, quantified by the interval in hours between the end of the procedure and passage of first stool.
D) Duration of hospital stay.
E) Surgical complications, such as wound infection, anastomotic leakage, bleeding
F) 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diverticulitis
Keywords
Diverticulitis; laparoscopy; short term outcome
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
laparoscopic sigmoid resection
Other Intervention Name(s)
laparoscopic-assisted sigmoid resection
Intervention Description
a laparoscopic 5 trocars approach for left colon mobilization, sigmoid colon transsection and intracorporeal colorectal anastomosis
Primary Outcome Measure Information:
Title
Postoperative pain at days 1, 2 and 3
Time Frame
7 days
Title
Morphine requirements at days 1, 2 and 3
Time Frame
4 days
Title
Duration of postoperative ileus
Time Frame
10 days
Secondary Outcome Measure Information:
Title
Medical complications
Time Frame
30 days
Title
Surgical complications
Time Frame
30 days
Title
Duration of surgical procedure
Time Frame
1 days
Title
Duration of hospital stay
Time Frame
2 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Morel, MD
Organizational Affiliation
University Hospital Geneva - Department of Surgery
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Surgery
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21556992
Citation
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.
Results Reference
derived
PubMed Identifier
20505508
Citation
Gervaz 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.
Results Reference
derived
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Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease
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