LapLAND Laparoscopic Lavage for Acute Non-Faeculant Diverticulitis (LapLAND)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified November 2009 by St Vincent's University Hospital, Ireland.
Recruitment status was: Enrolling by invitation

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

History of Changes

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 Intervention Model: Parallel Assignment Masking: Double Blind (Participant, Investigator) Primary Purpose: Treatment
Official Title:	Laparoscopic Lavage for Acute Non-Faeculant Diverticulitis

Resource links provided by NLM:

MedlinePlus related topics: Diverticulosis and Diverticulitis Health Facilities

U.S. FDA Resources

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

Primary Outcome Measures:

Operative and in-hospital mortality [ Time Frame: 1 year ]

Secondary Outcome Measures:

In-hospital and post-discharge morbidity [ Time Frame: 1 year ]
Rates of stoma formation [ Time Frame: 1 year ]
Rates of re-presentation with diverticulitis with or without perforation [ Time Frame: 1 year ]


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).

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 (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Inability to give informed consent (eg dementia).
Prior sigmoidectomy.
Ongoing steroid treatment >20mg/day.
Prior pelvic irradiation.
Requirement for inotropic support pre-operatively.
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:

Karoui M, Champault A, Pautrat K, Valleur P, Cherqui D, Champault G. Laparoscopic peritoneal lavage or primary anastomosis with defunctioning stoma for Hinchey 3 complicated diverticulitis: results of a comparative study. Dis Colon Rectum. 2009 Apr;52(4):609-15. doi: 10.1007/DCR.0b013e3181a0a674.

Myers E, Hurley M, O'Sullivan GC, Kavanagh D, Wilson I, Winter DC. Laparoscopic peritoneal lavage for generalized peritonitis due to perforated diverticulitis. Br J Surg. 2008 Jan;95(1):97-101.

O'Sullivan GC, Murphy D, O'Brien MG, Ireland A. Laparoscopic management of generalized peritonitis due to perforated colonic diverticula. Am J Surg. 1996 Apr;171(4):432-4.

Collins D, Winter DC. Elective resection for diverticular disease: an evidence-based review. World J Surg. 2008 Nov;32(11):2429-33. doi: 10.1007/s00268-008-9705-7. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Rogers AC, Collins D, O'Sullivan GC, Winter DC. Laparoscopic lavage for perforated diverticulitis: a population analysis. Dis Colon Rectum. 2012 Sep;55(9):932-8. doi: 10.1097/DCR.0b013e31826178d0.


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

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 July 17, 2017

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