Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease

February 17, 2009 updated by: University Hospital, Geneva

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Geneva, Switzerland, 1211
        • Department of Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Postoperative pain at days 1, 2 and 3
Time Frame: 7 days
7 days
Morphine requirements at days 1, 2 and 3
Time Frame: 4 days
4 days
Duration of postoperative ileus
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Medical complications
Time Frame: 30 days
30 days
Surgical complications
Time Frame: 30 days
30 days
Duration of surgical procedure
Time Frame: 1 days
1 days
Duration of hospital stay
Time Frame: 2 months
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Geneva

Investigators

  • Study Chair: Philippe Morel, MD, University Hospital Geneva - Department of Surgery

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

February 1, 2009

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

March 28, 2007

First Submitted That Met QC Criteria

March 28, 2007

First Posted (Estimate)

March 29, 2007

Study Record Updates

Last Update Posted (Estimate)

February 18, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

February 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CER 04-179

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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