Kliniken &… Kliniken Chirurgische Klinik… Studienzentrum der… Leistungsspektrum Publikationen

Studienprotokolle

Studienzentrum der Deutschen Gesellschaft für Chirurgie (SDGC)

Mack CE, Klaiber U, Sauer P, Kohlhas L, Baumann L, Martin E, Mehrabi A, Buchler MW, Hackert T.
Protocol of a randomised controlled phase II clinical trial investigating PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi to reduce bile leakage after hepatic resection: the PREBOT-II trial.
BMJ Open. 2023 Sep 20;13(9).

Heger P, Hackert T, Diener MK, Feißt M, Klose C, Dörr-Harim C, Möhlenbrock F, Büchler MW, Mihaljevic AL.
Conventional partial pancreatoduodenectomy versus an extended pancreatoduodenectomy (triangle operation) for pancreatic head cancers-study protocol for the randomised controlled TRIANGLE trial.
Trials. 2023 May 30;24(1):363.

Klotz R, Diener MK, Schmidt T, Hackert T, Graf S, Fuchs HF, Grimminger P, Egberts JH, Gockel I, van der Sluis PC, Doerr-Harim C, Klose C, Feißt M, Mihaljevic AL.
Overall morbidity after total minimally invasive keyhole oesophagectomy versus hybrid oesophagectomy (the MICkey trial): study protocol for a multicentre randomized controlled trial.
Trials. 2023 Mar 10;24(1):175.

Müller S, Weyhe D, Herrle F, Horvath P, Bachmann R, von Ehrlich-Treuenstätt V, Heger P, Nasir N, Klose C, Ritz A, Sander A, Grohmann E, Dörr-Harim C, Mihaljevic AL.
Prophylactic effect of retromuscular mesh placement during loop ileostomy closure on incisional hernia incidence-a multicentre randomised patient- and observer-blind trial (P.E.L.I.O.N trial).
Trials. 2023 Feb 1;24(1):76. 

Nickel F, Studier-Fischer A, Hausmann D, Klotz R, Vogel-Adigozalov SL, Tenckhoff S, Klose C, Feisst M, Zimmermann S, Babic B, Berlt F, Bruns C, Gockel I, Graf S, Grimminger P, Gutschow CA, Hoeppner J, Ludwig K, Mirow L, Mönig S, Reim D, Seyfried F, Stange D, Billeter A, Nienhüser H, Probst P, Schmidt T, Müller-Stich BP.
Minimally invasivE versus open total GAstrectomy (MEGA): study protocol for a multicentre randomised controlled trial (DRKS00025765).
BMJ Open. 2022 Oct 31;12(10).

Pausch TM, Holze M, Gesslein B, Rossion I, von Eisenhart Rothe F, Wagner M, Sander A, Tenckhoff S, Bartel M, Larmann J, Probst P, Pianka F, Hackert T, Klotz R.
Intraoperative visualisation of pancreatic leakage (ViP): study protocol for an IDEAL Stage I Post Market Clinical Study.
BMJ Open. 2022 Sep 8;12(9).

Klotz R, Dörr-Harim C, Bruckner T, Knebel P, Diener MK, Hackert T, Mihaljevic AL. 
Evaluation of robotic versus open partial pancreatoduodenectomy-study protocol for a randomised controlled pilot trial (EUROPA, DRKS00020407). 
Trials, 22(1), 40.

Ahmadi R, Campos B, Hajiabadi MM, Doerr-Harim C, Tenckhoff S, Rasche D, Unterberg A, Vesper J, Bruckner T, Tronnier V. 
Efficacy of different spinal cord stimulation paradigms for the treatment of chronic neuropathic pain (PARS-trial): study protocol for a double-blinded, randomized, and placebo-controlled crossover trial.
Trials 2021;22:87.

Probst P, Schuh F, Dörr-Harim C, Sander A, Bruckner T, Klose C, Rossion I, Nickel F, Müller-Stich BP, Mehrabi A, Hackert T, Büchler MW, Diener MK.
Protocol for a randomised controlled trial to compare postoperative complications between minimally invasive and open DIStal PAnCreaTectomy (DISPACT-2 trial).
BMJ Open. 2021 Feb 22;11(2):e047867.

Klaiber U, Sauer P, Martin E, Bruckner T, Luntz S, Tjaden C, Probst P, Knebel P, Diener MK, Buchler MW, Hackert T.
Protocol of a randomised controlled phase II clinical trial investigating PREoperative endoscopic injection of BOTulinum toxin into the sphincter of Oddi to reduce postoperative pancreatic fistula after distal pancreatectomy: the PREBOTPilot trial.
BMJ Open. 2020 Sep 2;10(9):e036815.

Hüttner FJ, Probst P, Mihaljevic A, Contin P, Dörr-Harim C, Ulrich A, Schneider M, Büchler MW, Diener MK, Knebel P. 
Ghost ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer (DRKS00013997): protocol for a randomised controlled trial. 
BMJ Open. 2020 Oct 15;10(10):e038930.

Hüttner FJ, Rooman I, Bouche G, Knebel P, Hüsing J, Mihaljevic AL, Hackert T, Strobel O, Büchler MW, Diener MK.
Pancreatic resection with perioperative drug repurposing of propranolol and etodolac: trial protocol of the phase-II randomised placebo controlled PROSPER trial.
BMJ Open. 2020 Sep 30;10(9):e040406.

Heger P, Feißt M, Krisam J, Klose C, Dörr-Harim C, Tenckhoff S, Büchler MW, Diener MK, Mihaljevic AL.
Hernia reduction following laparotomy using small stitch abdominal wall closure with and without mesh augmentation (the HULC trial): study protocol for a randomized controlled trial.
Trials. 2019;20(1):738. Published 2019 Dec 16.

Fink CA, Friedrich M, Frey PE, Rädeker L, Leuck A, Bruckner T, Feisst M, Tenckhoff S, Klose C, Dörr-Harim C, Neudecker J, Mihaljevic AL.
Prospective multicentre cohort study of PATient-reported outcomes and complications following major abdominal neoplastic surgery (PATRONUS) – study protocol for a CHIR-Net student-initiated German medical audit study (CHIR-Net SIGMA study).
BMC Surg. 2018 Oct 29;18(1):90.

Chapman SJ; EuroSurg Collaborative (Mihaljevic A/Germany).
Ileus Management International (IMAGINE): protocol for a multicentre, observational study of ileus after colorectal surgery.
Colorectal Dis. 2018 Jan;20(1):O17-O25. doi: 10.1111/codi.13976.

Klotz R, Hofer S, Schellhaaß A, Dörr-Harim C, Tenckhoff S, Bruckner T, Klose C, Diener MK, Weigand MA, Büchler MW, Knebel P.
Intravenous versus epidural analgesia to reduce the incidence of gastrointestinal complications after elective pancreatoduodenectomy (the PAKMAN trial, DRKS 00007784): study protocol for a randomized controlled trial.
Trials. 2016 Apr 11;17(1):194.

Sandra-Petrescu F, Herrle F, Hinke A, Rossion I, Suelberg H, Post S, Hofheinz RD, Kienle P.
CoCStom trial: study protocol for a randomised trial comparing completeness of adjuvant chemotherapy after early versus late diverting stoma closure in low anterior resection for rectal cancer.
BMC Cancer. 2015 Nov 21;15(1):923.

Fischer L, Wekerle AL, Bruckner T, Wegener I, Diener MK, Frankenberg MV, Gärtner D, Schön MR,
Raggi MC, Tanay E, Brydniak R, Runkel N, Attenberger C, Son MS, Türler A, Weiner R, Büchler MW, Müller-Stich BP.
BariSurg trial: Sleeve gastrectomy versus Roux-en-Y gastric bypass in obese patients with BMI 35-60 kg/m(2) - a multi-centre randomized patient and observer blind non-inferiority trial.
BMC Surg. 2015 Jul 18;15:87.

Hüttner FJ, Bruckner T, Alldinger I, Hennes R, Ulrich A, Büchler MW, Diener MK, Knebel P.
Frequency of pneumothorax and haemothorax after primary open versus closed implantation strategies for insertion of a totally implantable venous access port in oncological patients: study protocol for a randomised controlled trial.
Trials. 2015 Mar 31;16(1):128.

Hassenpflug M, Bruckner T, Knebel P, Diener MK, Büchler MW, Werner J.
DISCOVER trial- Distal resection of the pancreas with or without coverage of the pancreatic remnant: study protocol of a randomised controlled trial.
Trials. 2013 Dec 14;14:430. doi: 10.1186/1745-6215-14-430.

Nieuwenhuizen J, Eker HH, Timmermans L, Hop WC, Kleinrensink GJ, Jeekel J, Lange JF; PRIMA Trialist Group.
A double blind randomized controlled trial comparing primary suture closure with mesh augmented closure to reduce incisional hernia incidence.
BMC Surg. 2013 Oct 28;13:48. doi: 10.1186/1471-2482-13-48.

Fink C, Diener MK, Bruckner T, Müller G, Paulsen L, Keller M, Büchler MW, Knebel P.
Impact of preoperative patient education on prevention of postoperative complications after major visceral surgery: study protocol for a randomized controlled trial (PEDUCAT trial).
Trials. 2013 Aug 26;14(1):271. doi: 10.1186/1745-6215-14-271.

Kenngott HG, Clemens G, Gondan M, Senft J, Diener MK, Rudofsky G, Nawroth PP, Büchler MW, Fischer L, Müller-Stich BP.
DiaSurg 2 trial - surgical vs. medical treatment of insulin-dependent type 2 diabetes mellitus in patients with a body mass index between 26 and 35 kg/m2: study protocol of a randomized controlled multicenter trial - DRKS00004550.
Trials. 2013 Jun 20;14(1):183.

Hackert T, Bruckner T, Dörr-Harim C, Diener MK, Knebel P, Hartwig W, Strobel O, Fritz S, Schneider L, Werner J, Büchler MW.
Pylorus resection or pylorus preservation in partial pancreatico-duodenectomy (PROPP study): study protocol for a randomized controlled trial.
Trials. 2013 Feb 14;14:44. doi: 10.1186/1745-6215-14-44.

Rothenhoefer S, Herrle F, Herold A, Joos A, Bussen D, Kieser M, Schiller P, Klose C, Seiler CM, Kienle P, Post S.
DeloRes trial: study protocol for a randomized trial comparing two standardized surgical approaches in rectal prolapse - Delorme's procedure versus resection rectopexy.
Trials. 2012 Aug 29;13:155.

Rahbari NN, Knebel P, Kieser M, Bruckner T, Bartsch DK, Friess H, Mihaljevic
AL, Stern J, Diener MK, Voss S, Rossion I, Buechler MW, Seiler CM.
Design and current status of CONTINT: continuous versus interrupted abdominal wall closure after emergency midline laparotomy - a randomized controlled multicenter trial
[NCT00544583].
Trials 2012 May 30;13(1):72.

Wellner UF, Brett S, Bruckner T, Limprecht R, Rossion I, Seiler C, Sick O, Wegener I, Hopt UT, Keck T; RECOPANC Trial Group.
Pancreatogastrostomy versus pancreatojejunostomy for RECOnstruction after partial PANCreatoduodenectomy (RECOPANC): study protocol of a randomized controlled trial UTN U1111-1117-9588.
Trials. 2012 Apr 27;13:45.

Rahbari NN, Lordick F, Fink C, Bork U, Stange A, Jager D, Luntz SP, Englert S,
Rossion I, Koch M, Buchler MW, Kieser M, Weitz J.
Resection of the primary tumour versus no resection prior to systemic therapy in patients with colon cancer and synchronous unresectable metastases (UICC stage IV): SYNCHRONOUS - A randomised controlled multicentre trial (ISRCTN30964555).
BMC Cancer. 2012 Apr 5;12(1):142.

Heger U, Voss S, Knebel P, Doerr-Harim C, Neudecker J, Schuhmacher C, Faist E, Diener MK, Kieser M, Seiler CM, Buchler MW.
Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial.
Trials. 2011 Nov 21;12(1):245.

Bartl C, Stengel D, Bruckner T, Rossion I, Luntz S, Seiler C, Gebhard F.
Open reduction and internal fixation versus casting for highly comminuted and intra-articular fractures of the distal radius (ORCHID): protocol for a randomized clinical multi-center trial.
Trials. 2011 Mar 22;12:8.

Loffler T, Seiler CM, Rossion I, Kijak T, Thomusch O, Hodina R, Kruger M, Simon T, Bruckner T, Kieser M, Buechler MW, Weitz J, Group HT.
HAnd-suture versus STApling for Closure of Loop Ileostomy: HASTA-Trial: a study rationale and design for a randomized controlled trial.
Trials. 2011 Feb 8;12(1):34.

Diener MK, Bruckner T, Contin P, Halloran C, Glanemann M, Schlitt HJ, Mossner J, Kieser M, Werner J, Buchler MW and Seiler CM.
ChroPac-Trial: Duodenum-preserving pancreatic head resection versus pancreatoduodenectomy for chronic pancreatitis. Trial protocol of a randomised controlled multicentre trial.
Trials. 2010 April 29;11:47.

Diener MK, Knaebel HP, Witte St, Büchler MW, Seiler CM and the DISPACT Trial Group.
DISPACT: A randomized controlled trial to compare two different surgical techniques of Distal Pancreatectomy: Study rationale and design (ISRCTN 18452029).
Clinical Trials. 2008;5;534.

Schlosser K, Veit JA, Witte St, Fernandez E, Victor N, Knaebel H-P, Seiler CM, Rothmund M.
Comparison of total parathyroidectomy without autotransplantation and without thymectomy versus total parathyroidectomy with autotransplantation and with thymectomy for secondary hyperparathyroidism: TOPAR PILOT-Trial.
Trials. 2007 September 18;8:22.

Seiler CM, Fröhlich BE, Veit JA, Gazyakan E, Wente MN, Knauer C, Deckert A, Witte S, Victor N, Büchler MW, Knaebel HP and the CLIVIT Study Group.
Protocol design and current status of CLIVIT: A randomized controlled multicenter relevance trial comparing clips versus ligatures in thyroid surgery (ISRCTN 96901396).
Trials. 2006 Sep 1;7(1):27.

Knaebel HP, Koch M, Sauerland S, Diener MK, Büchler MW, Seiler CM and the INSECT-Study Group of the Study Centre of the German Surgical Society.
Interrupted or continuous slowly absorbable sutures – Design of a multi-centre randomized controlled trial to evaluate abdominal closure techniques- INSECT-Trial [ISRCTN 24023541].
BMC Surg. 2005 Mar 8;5(1):3.