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.
Swank
Hilko A
HA
Department of Surgery, Academic Medical Centre, Amsterdam, The Netherlands.
Vermeulen
Jefrey
J
Lange
Johan F
JF
Mulder
Irene M
IM
van der Hoeven
Joost A B
JA
Stassen
Laurents P S
LP
Crolla
Rogier M P H
RM
Sosef
Meindert N
MN
Nienhuijs
Simon W
SW
Bosker
Robbert J I
RJ
Boom
Maarten J
MJ
Kruyt
Philip M
PM
Swank
Dingeman J
DJ
Steup
Willem H
WH
de Graaf
Eelco J R
EJ
Weidema
Wibo F
WF
Pierik
Robert E G J M
RE
Prins
Hubert A
HA
Stockmann
Hein B A C
HB
Tollenaar
Rob A E M
RA
van Wagensveld
Bart A
BA
Coene
Peter-Paul L O
PP
Slooter
Gerrit D
GD
Consten
Esther C J
EC
van Duijn
Eino B
EB
Gerhards
Michael F
MF
Hoofwijk
Anton G M
AG
Karsten
Thomas M
TM
Neijenhuis
Peter A
PA
Blanken-Peeters
Charlotte F J M
CF
Cense
Huib A
HA
Mannaerts
Guido H H
GH
Bruin
Sjoerd C
SC
Eijsbouts
Quirijn A J
QA
Wiezer
Marinus J
MJ
Hazebroek
Eric J
EJ
van Geloven
Anna A W
AA
Maring
John K
JK
D'Hoore
André J L
AJ
Kartheuser
Alex
A
Remue
Christophe
C
van Grevenstein
Helma M U
HM
Konsten
Joop L M
JL
van der Peet
Donald L
DL
Govaert
Marc J P M
MJ
Engel
Alexander F
AF
Reitsma
Johannes B
JB
Bemelman
Willem A
WA
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