LapLAND Laparoscopic Lavage for Acute Non-Faeculant Diverticulitis

NCT01019239 | Unknown DMC

• 1 other identifier: LapLAND
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Diverticulitis

Keywords

Non-faeculant; Perforated; Diverticulitis

Outcome Measures

Primary Outcomes (1)

• Operative and in-hospital mortality

  1 year

Secondary Outcomes (3)

• In-hospital and post-discharge morbidity

  1 year

• Rates of stoma formation

  1 year

• Rates of re-presentation with diverticulitis with or without perforation

  1 year

Study Arms (2)

Laparoscopic Washout

EXPERIMENTAL

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

Conventional Treatment

ACTIVE COMPARATOR

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

Interventions

Laparoscopic Washout PROCEDURE

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.

Laparoscopic Washout

Hartmann's Procedure/ Primary Resection and Anastomosis PROCEDURE

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).

Conventional Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• St Vincent's University Hospital, Ireland: lead

Study Sites (1)

Royal College of Surgeons in Ireland

Dublin, Dublin, D2, Ireland

Location

Related Publications (5)

• 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.

  PMID: 19404062 BACKGROUND

• 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. doi: 10.1002/bjs.6024.

  PMID: 18076019 BACKGROUND

• 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. doi: 10.1016/S0002-9610(97)89625-0.

  PMID: 8604837 BACKGROUND

• 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.

  PMID: 18712563 BACKGROUND

• 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.

  PMID: 22874599 DERIVED

MeSH Terms

Conditions

Diverticulitis

Interventions

Anastomosis, Surgical

Condition Hierarchy (Ancestors)

Diverticular Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative

Study Officials

• Aisling M Hogan, MD

  St Vincent's University Hospital, Ireland

  STUDY DIRECTOR

• Kieran Ryan, BSc

  Royal College of Surgeons in Ireland

  STUDY DIRECTOR

• Des C Winter, MD

  St Vincent's University Hospital and Royal College of Surgeons in Ireland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: November 23, 2009
• First Posted: November 25, 2009
• Study Start: January 1, 2010
• Primary Completion: December 1, 2015
• Study Completion: December 1, 2015
• Last Updated: December 1, 2009

Record last verified: 2009-11

Locations

IE (1)