A concept for trial institutions focussing on randomised controlled trials in surgery

Table 1 Features of single-centre sRCTs (KSC) and multi-centre sRCTs (SDGC) (09/2007)

	Trial/ISRCTN	Interventions	Primary Endpoint	Sample size/Randomised patients/Clinical Sites
KSC	BEGER/BERN 50638764 [17]	Beger vs Berne procedure for surgical treatment of chronic pancreatitis	Duration of surgery Quality of life Time at ICU Duration of hospital stay	65/65
	POUCH 78983587	Transverse Coloplasty versus J-Pouch for low anterior rectal resection	Difficulties with evacuation after 2 years	150/150
	POVATI 60734227 [18]	Midline vs transverse laparotomy	Pain and use of analgesics	200/200
	LAPCON-POUCH 61411448 [19]	Laparoscopic vs. open total proctocolectomy with ileo-anal pouch anastomosis	Blood loss Units packed cells	130/30
	PORTAS 52368201 [20]	Venae Sectio vs. modified Seldinger Technique for Totally Implantable Access Ports	Primary success rate of surgical technique	164/164
SDGC	INSECT 24023541 [14]	Running vs interrupted fascia closure after midline laparotomy	Incisional hernia	600/624/25
	CLIVIT 96901396 [15]	Clips vs ligation in thyroid surgery	Duration of surgery	400/265/5
	DISPACT 18452029	Stapling vs scalpel transsection and hand-suture for distal pancreatectomy	Pancreatic fistula and mortality	550/101/25
	TOPAR-PILOT 86202793 [21]	Autotransplantation vs none after total parathyroidectomy	Recurrence of secondary hyperparathyroidism	100/16/7

ISRCTN = International Standard Randomised Controlled Trial Number http://www.controlled-trials.com
BEGER/BERN Duodenum preserving pancreatectomy in chronic pancreatitis: A randomised controlled trial comparing two surgical techniques; POUCH Colon J-Pouch versus Transverse Coloplasty Pouch after low anterior resection for rectal cancer: a randomised controlled trial; POVATI Postsurgical pain outcome of vertical and transverse abdominal incision – A randomised controlled equivalence trial; PORTAS Comparison of Venae Sectio vs. modified Seldinger Technique for Totally Implantable Access Ports; LAPCON-POUCH Totally laparoscopic vs conventional ileo-anal pouch procedure – design of a single-centre, expertise based randomised controlled trial to compare the laparoscopic and conventional surgical approach in patients undergoing primary elective restorative proctocolectomy; INSECT Interrupted vs continuous slowly absorbable sutures – evaluation of abdominal closure techniques; CLIVIT Clips vs ligature in thyroid surgery – a randomised controlled trial; DISPACT Distal pancreatectomy – A randomised controlled trial to compare to different surgical techniques; TOPAR-Pilot Secondary hyperparathyroidism: does total parathyroidectomy alone lead to lower rate of recurrence than total parathyroidectomy with autotransplantation? – A randomised controlled pilot trial.

ISSN: 1745-6215