Ignite Creation Date:
2024-05-05 @ 5:25 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00453830
Status:
COMPLETED
Last Update Posted:
2009-02-18
First Post:
2007-03-28
Brief Title:
Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease
Sponsor:
University Hospital Geneva
Organization:
University Hospital Geneva
Study Overview
Official Title:
Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease A Prospective Randomized Single-Blind Trial
Status:
COMPLETED
Status Verified Date:
2009-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 100000year
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
1 Patients who had two episodes of uncomplicated diverticulitis
2 Patients who had one episode of complicated perforated diverticulitis with either pericolic of pelvic abscesses Hinchey stage I and II respectively fistula formation andor 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
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
1 Patients who had two episodes of uncomplicated diverticulitis
2 Patients who had one episode of complicated perforated diverticulitis with either pericolic of pelvic abscesses Hinchey stage I and II respectively fistula formation andor 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None