LapLAND Laparoscopic Lavage for Acute Non-Faeculant Diverticulitis

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
St Vincent's University Hospital, Ireland
ClinicalTrials.gov Identifier:
NCT01019239
First received: November 23, 2009
Last updated: November 30, 2009
Last verified: November 2009
  Purpose

The aim of the study is to compare patient outcome following standard of care (Hartmann's or resection with anastomosis and defunctioning stoma) and a 'new therapy' (laparoscopic lavage alone) for the treatment of acute perforated non-faeculant diverticulitis in Irish hospitals.

Perforated diverticulitis requires emergency surgery. This carries significant risks and mortality as high as 15% during the index admission has been reported. Our group has established the safety of laparoscopic lavage alone on the largest cohort to date in a prospective multi-institutional study of 100 patients, providing convincing evidence that laparoscopic lavage alone is a reasonable alternative to resection for non-faeculant perforated diverticulitis. Our aim now is to translate this well-established study design into a protocol for a multi-institutional randomised control trial as direct comparison is the only way to provide convincing evidence of one modality over another.

All patients will be followed up for twelve months and primary (operative and in-hospital mortality) and secondary (in-hospital and post-discharge morbidity; rates of stoma formation; rates of re-presentation with diverticulitis with or without perforation.) end-points will be recorded.

Sample size calculations reveal that a patient cohort of 100 in each arm will be sufficient to detect a difference in morbidity and mortality between groups The ratio between Hinchey 3 and Hinchey 4 is estimated to be approximately 2:1. In order to guarantee sufficient sample size, therefore, 300 patients must fulfil the study criteria allowing for exclusion of 100 at time of operation


Condition Intervention
Diverticulitis
Procedure: Laparoscopic Washout
Procedure: Hartmann's Procedure/ Primary Resection and Anastomosis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Laparoscopic Lavage for Acute Non-Faeculant Diverticulitis

Resource links provided by NLM:


Further study details as provided by St Vincent's University Hospital, Ireland:

Primary Outcome Measures:
  • Operative and in-hospital mortality [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In-hospital and post-discharge morbidity [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Rates of stoma formation [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Rates of re-presentation with diverticulitis with or without perforation [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2010
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Laparoscopic Washout
Two 5mm ports will be placed in the suprapubic and right lower quadrants to facilitate triangulation of instruments during manipulation and lavage. The peritoneal cavity will be thoroughly examined and stage classified according to Hinchey. Peritoneal lavage will be performed in all four quadrants using at least 4 litres of warmed saline until the drainage is clear. Two non-suction Penrose drains will be placed. Intravenous antibiotics will be continued for a minimum of 72hours and oral antibiotics will be continued for one week. Oral fluids will be commenced on the first postoperative day and diet will be introduced subsequently, depending on clinical status. Early mobilisation will be encouraged.
Procedure: Laparoscopic Washout
Pneumoperitoneum will be established via a blunt entry 12mm umbilical port. Two 5mm ports will be placed in the suprapubic and right lower quadrants. The peritoneal cavity will be thoroughly examined and stage classified according to Hinchey. Peritoneal lavage will be performed in all four quadrants using at least 4 litres of warmed saline until the drainage is clear. Two non-suction Penrose drains will be placed.
Active Comparator: Conventional Treatment
Operative procedure will be similar to that previously described.Patients randomised to the second arm will undergo standard management (according to local preference) which will consist of Hartmanns Procedure or Primary resection of the diseased segment and anastomosis. Post operative care will be standardised between arms as described in the protocol
Procedure: Hartmann's Procedure/ Primary Resection and Anastomosis
24 Pneumoperitoneum will be established via a blunt entry 12mm umbilical port. Two 5mm ports will be placed in the suprapubic and right lower quadrants to facilitate triangulation of instruments during manipulation and lavage. The peritoneal cavity will be thoroughly examined and stage classified according to Hinchey. . In the absence of faeculant peritonitis, patients will be randomised to undergo Hartmann's procedure or primary resection and anastomosis (depending on standard practice in the individual unit).

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 18-85 years..
  2. Clinical evidence of generalised peritonitis.
  3. Free air on erect chest x-ray or CT abdomen suggestive of perforated diverticulitis.
  4. Informed consent.

Exclusion Criteria:

  1. Inability to give informed consent (eg dementia).
  2. Prior sigmoidectomy.
  3. Ongoing steroid treatment >20mg/day.
  4. Prior pelvic irradiation.
  5. Requirement for inotropic support pre-operatively.
  6. Faecal peritonitis or overt sigmoid perforation (demonstrated on laparoscopy).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019239

Locations
Ireland
Royal College of Surgeons in Ireland
Dublin, Ireland, D2
Sponsors and Collaborators
St Vincent's University Hospital, Ireland
Investigators
Study Director: Aisling M Hogan, MD St. Vincent's University Hospital
Study Director: Kieran Ryan, BSc Royal College of Surgeons in Ireland
Principal Investigator: Des C Winter, MD St Vincent's University Hospital and Royal College of Surgeons in Ireland
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Professor Des C Winter, St. Vincent's University Hospital, Elm Park, Dublin 4.
ClinicalTrials.gov Identifier: NCT01019239     History of Changes
Other Study ID Numbers: LapLAND
Study First Received: November 23, 2009
Last Updated: November 30, 2009
Health Authority: Ireland: Medical Ethics Research Committee

Keywords provided by St Vincent's University Hospital, Ireland:
Non-faeculant
Perforated
Diverticulitis

Additional relevant MeSH terms:
Diverticulitis
Intraabdominal Infections
Infection
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 18, 2014