Laparoscopic Versus Open Sigmoid Colectomy for Diverticular Disease

NCT00453830 | Completed Phase 4

• 1 other identifier: CER 04-179
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Diverticulitis

Keywords

Diverticulitis; laparoscopy; short term outcome

Outcome Measures

Primary Outcomes (3)

• Postoperative pain at days 1, 2 and 3

  7 days

• Morphine requirements at days 1, 2 and 3

  4 days

• Duration of postoperative ileus

  10 days

Secondary Outcomes (4)

• Medical complications

  30 days

• Surgical complications

  30 days

• Duration of surgical procedure

  1 days

• Duration of hospital stay

  2 months

Interventions

laparoscopic sigmoid resection PROCEDURE

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

Also known as: laparoscopic-assisted sigmoid resection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Study Sites (1)

Department of Surgery

Geneva, Canton of Geneva, 1211, Switzerland

Location

Related Publications (2)

• Gervaz P, Mugnier-Konrad B, Morel P, Huber O, Inan I. Laparoscopic versus open sigmoid resection for diverticulitis: long-term results of a prospective, randomized trial. Surg Endosc. 2011 Oct;25(10):3373-8. doi: 10.1007/s00464-011-1728-8. Epub 2011 May 10.

  PMID: 21556992 DERIVED

• Gervaz P, Inan I, Perneger T, Schiffer E, Morel P. A prospective, randomized, single-blind comparison of laparoscopic versus open sigmoid colectomy for diverticulitis. Ann Surg. 2010 Jul;252(1):3-8. doi: 10.1097/SLA.0b013e3181dbb5a5.

  PMID: 20505508 DERIVED

MeSH Terms

Conditions

Diverticulitis

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Philippe Morel, MD

  University Hospital Geneva - Department of Surgery

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 28, 2007
• First Posted: March 29, 2007
• Study Start: January 1, 2005
• Primary Completion: February 1, 2009
• Study Completion: February 1, 2009
• Last Updated: February 18, 2009

Record last verified: 2009-02

Locations

CH (1)