Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease - Full Text View

Sponsored by:	University Hospital, Geneva
Information provided by:	University Hospital, Geneva
ClinicalTrials.gov Identifier:	NCT00453830

Purpose

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.

Condition	Intervention	Phase
Diverticulitis	Procedure: laparoscopic sigmoid resection	Phase IV

MedlinePlus related topics: Diverticulosis and Diverticulitis Surgery

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Subject), Active Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease: A Prospective Randomized Single-Blind Trial

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:

Postoperative pain at days 1, 2 and 3 [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
Morphine requirements at days 1, 2 and 3 [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Duration of postoperative ileus [ Time Frame: 10 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Medical complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Surgical complications [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]
Duration of surgical procedure [ Time Frame: 1 days ] [ Designated as safety issue: No ]
Duration of hospital stay [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	January 2005
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	December 2008 (Final data collection date for primary outcome measure)

Intervention Details:

a laparoscopic 5 trocars approach for left colon mobilization, sigmoid colon transsection and intracorporeal colorectal anastomosis

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.

Eligibility

Ages Eligible for Study:	18 Years to 80 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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.)

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453830

Contacts

Contact: Pascal Gervaz, MD

+41-22-3727715 ext 6858148

pascal.gervaz@hcuge.ch

Locations

Switzerland
Department of Surgery	Recruiting
Geneva, Switzerland, 1211
Contact: Pascal Gervaz, MD +41-22-3727715 pascal.gervaz@hcuge.ch

Sponsors and Collaborators

University Hospital, Geneva

Investigators

Study Chair:

Philippe Morel, MD

University Hospital Geneva - Department of Surgery

More Information

No publications provided

Responsible Party:	University Hospital Geneva ( Pascal Gervaz )
Study ID Numbers:	CER 04-179
Study First Received:	March 28, 2007
Last Updated:	June 16, 2008
ClinicalTrials.gov Identifier:	NCT00453830
Health Authority:	Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:

Diverticulitis; laparoscopy; short term outcome

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Diverticulitis
Diverticulum

Additional relevant MeSH terms:

Pathologic Processes

ClinicalTrials.gov processed this record on February 12, 2009