The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037).
BACKGROUND
Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis).


METHODS
In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs.


CONCLUSIONS
The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis.


BACKGROUND
Nederlands Trial Register NTR2037.
Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
Hilko A
HA
Swank
Jefrey
J
Vermeulen
Johan F
JF
Lange
Irene M
IM
Mulder
Joost A B
JA
van der Hoeven
Laurents P S
LP
Stassen
Rogier M P H
RM
Crolla
Meindert N
MN
Sosef
Simon W
SW
Nienhuijs
Robbert J I
RJ
Bosker
Maarten J
MJ
Boom
Philip M
PM
Kruyt
Dingeman J
DJ
Swank
Willem H
WH
Steup
Eelco J R
EJ
de Graaf
Wibo F
WF
Weidema
Robert E G J M
RE
Pierik
Hubert A
HA
Prins
Hein B A C
HB
Stockmann
Rob A E M
RA
Tollenaar
Bart A
BA
van Wagensveld
Peter-Paul L O
PP
Coene
Gerrit D
GD
Slooter
Esther C J
EC
Consten
Eino B
EB
van Duijn
Michael F
MF
Gerhards
Anton G M
AG
Hoofwijk
Thomas M
TM
Karsten
Peter A
PA
Neijenhuis
Charlotte F J M
CF
Blanken-Peeters
Huib A
HA
Cense
Guido H H
GH
Mannaerts
Sjoerd C
SC
Bruin
Quirijn A J
QA
Eijsbouts
Marinus J
MJ
Wiezer
Eric J
EJ
Hazebroek
Anna A W
AA
van Geloven
John K
JK
Maring
André J L
AJ
D'Hoore
Alex
A
Kartheuser
Christophe
C
Remue
Helma M U
HM
van Grevenstein
Joop L M
JL
Konsten
Donald L
DL
van der Peet
Marc J P M
MJ
Govaert
Alexander F
AF
Engel
Johannes B
JB
Reitsma
Willem A
WA
Bemelman
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000714:Anastomosis, Surgical; D003082:Colectomy; D003125:Colostomy; D004238:Diverticulitis / Q000150:complications*; D005260:Female; D006801:Humans; D007416:Intestinal Perforation / Q000209:etiology / Q000601:surgery*; D010535:Laparoscopy; D008875:Middle Aged; D010533:Peritoneal Lavage / Q000379:methods*; D010538:Peritonitis / Q000209:etiology / Q000601:surgery*; D016896:Treatment Outcome