LapLAND Laparoscopic Lavage for Acute Non-Faeculant Diverticulitis (LapLAND)
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|ClinicalTrials.gov Identifier: NCT01019239|
Recruitment Status : Unknown
Verified November 2009 by St Vincent's University Hospital, Ireland.
Recruitment status was: Enrolling by invitation
First Posted : November 25, 2009
Last Update Posted : December 1, 2009
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 or disease||Intervention/treatment||Phase|
|Diverticulitis||Procedure: Laparoscopic Washout Procedure: Hartmann's Procedure/ Primary Resection and Anastomosis||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Laparoscopic Lavage for Acute Non-Faeculant Diverticulitis|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2015|
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).
- Operative and in-hospital mortality [ Time Frame: 1 year ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01019239
|Royal College of Surgeons in Ireland|
|Dublin, Ireland, D2|
|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|