Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease

Diverticulitis Clinical Trial

Official title:

Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease: A Prospective Randomized Single-Blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00453830
• Other study ID #: CER 04-179
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2007
• Last updated: February 17, 2009
• Start date: January 2005
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical 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 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.

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:

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diverticulitis
• Diverticulum

Intervention

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

Locations

Country	Name	City	State
Switzerland	Department of Surgery	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative pain at days 1, 2 and 3		7 days	Yes
Primary	Morphine requirements at days 1, 2 and 3		4 days	No
Primary	Duration of postoperative ileus		10 days	No
Secondary	Medical complications		30 days	Yes
Secondary	Surgical complications		30 days	Yes
Secondary	Duration of surgical procedure		1 days	No
Secondary	Duration of hospital stay		2 months	No