Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease
Condition: Diverticulitis
MeSH terms: Diverticulitis; Diverticular Diseases; Diverticulum
Study type: Interventional
Phase: Phase 4

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:

        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.
    

Intervention name(s): laparoscopic sigmoid resection
Intervention type(s): Procedure
Intervention description(s): a laparoscopic 5 trocars approach for left colon mobilization, sigmoid colon transsection and intracorporeal colorectal anastomosis
Other intervention name(s): laparoscopic-assisted sigmoid resection
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Diverticulitis; laparoscopy; short term outcome