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Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease

NCT00453830 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2009-02-18

No results posted yet for this study

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.

Conditions

  • Diverticulitis

Interventions

PROCEDURE

laparoscopic sigmoid resection

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

Sponsors & Collaborators

  • University Hospital, Geneva

    lead OTHER

Principal Investigators

  • Philippe Morel, MD · University Hospital Geneva - Department of Surgery

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2009-02-28
Completion
2009-02-28

Countries

  • Switzerland

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00453830 on ClinicalTrials.gov