Ghost-ileostomy versus conventional loop ileostomy in patients undergoing low anterior resection for rectal cancer: results of a randomised controlled multicentre pilot trial (DRKS00013997).

Purpose: The objective of the current pilot trial was to evaluate whether ghost ileostomy is a safe alternative to the current standard of care in terms of a conventional loop ileostomy in patients undergoing low anterior resection with total mesorectal excision (LAR/TME) for rectal cancer.

Methods: This randomized controlled pilot trial included patients undergoing LAR/TME, randomly assigning them to ghost ileostomy or conventional loop ileostomy intraoperatively. Follow-up spanned 6 months, evaluating the following endpoints: comprehensive complication index (CCI), postoperative morbidity, transformation of ghost ileostomy, presence of ostomy at 6 months, Wexner score, and quality of life (EORTC QLQ-C30 & CR29).

Thoracic Epidural Analgesia Is Not Associated With Improved Survival After Pancreatic Surgery: Long-Term Follow-Up of the Randomized Controlled PAKMAN Trial.

Background: Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are common forms of analgesia after pancreatic surgery. Current guidelines recommend EDA over PCIA, and evidence suggests that EDA may improve long-term survival after surgery, especially in cancer patients. The aim of this study was to determine whether perioperative EDA is associated with an improved patient prognosis compared to PCIA in pancreatic surgery.

Overall morbidity after total minimally invasive keyhole oesophagectomy versus hybrid oesophagectomy (the MICkey trial): study protocol for a multicentre randomized controlled trial.

Background: Oesophageal cancer (EC) is the sixth leading cause of cancer death worldwide. Oesophageal resection is the only curative treatment option for EC which is frequently performed via an abdominal and right thoracic approach (Ivor-Lewis operation). This 2-cavity operation is associated with a high risk of major complications.

Measuring patient centeredness with German language Patient-Reported Experience Measures (PREM)-A systematic review and qualitative analysis according to COSMIN.

Background: Patient centeredness is an integral part of the quality of care. Patient-reported experience measures (PREMs) are assumed to be an appropriate tool to assess patient-centredness. An evaluation of German-speaking PREMs is lacking.

Clinical outcomes of patients treated on the Heidelberg interprofessional training ward vs. care on a conventional surgical ward: A retrospective cohort study.

Interprofessional training wards (IPTW) are a form of interprofessional education enabling trainees of different healthcare professions to work together in teams. Concerns about patient safety are a major barrier to the implementation of IPTWs. The objective of this retrospective study was to analyze patient relevant clinical outcomes on Germany's first IPTW (; HIPSTA) in the Department of Surgery at University Hospital Heidelberg in comparison to a conventional surgical ward (CSW).

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.

Background: Spinal cord stimulation (SCS) is an effective method to treat neuropathic pain; however, it is challenging to compare different stimulation modalities in an individual patient, and thus, it is largely unknown which of the many available SCS modalities is most effective. Specifically, electrodes leading out through the skin would have to be consecutively connected to different, incompatible SCS devices and be tested over a time period of several weeks or even months. The risk of wound infections for such a study would be unacceptably high and blinding of the trial difficult.

Randomised-controlled feasibility trial on abdominal wall closure techniques in patients undergoing relaparotomy (ReLap study; DRKS00013001).

Background: Patients undergoing relaparotomy are generally underrepresented in clinical trials, despite how common the procedure is in clinical practice. Specifically, techniques for re-do abdominal wall closure have never been evaluated in a randomised-controlled trial. The aim of this trial was to identify the optimal abdominal wall closure technique in patients undergoing relaparotomy.

Gastrointestinal Complications After Pancreatoduodenectomy With Epidural vs Patient-Controlled Intravenous Analgesia: A Randomized Clinical Trial.

Importance: Morbidity is still high in pancreatic surgery, driven mainly by gastrointestinal complications such as pancreatic fistula. Perioperative thoracic epidural analgesia (EDA) and patient-controlled intravenous analgesia (PCIA) are frequently used for pain control after pancreatic surgery. Evidence from a post hoc analysis suggests that PCIA is associated with fewer gastrointestinal complications.

Abdominal drainage versus no drainage after distal pancreatectomy: study protocol for a randomized controlled trial.

Background: The placement of prophylactic intra-abdominal drains has been common practice in abdominal operations including pancreatic surgery. The PANDRA trial showed that the omission of drains following pancreatic head resection was non-inferior to intra-abdominal drainage in terms of postoperative reinterventions and superior in terms of clinically relevant pancreatic fistula rate and fistula-associated complications. The aim of the present PANDRA II trial is to evaluate the clinical outcome with versus without prophylactic drain placement after distal pancreatectomy.

Prospective mixed-methods study of patients undergoing relaparotomy (ReLap study; DRKS00013001).

Background: Patients undergoing relaparotomies are underrepresented in clinical trials. Standard of care, relative outcomes compared to primary laparotomy, and the ideal fascial closure technique are unknown.

Objective: The ReLap study has three objectives: First, to determine standard of care and gain evidence of intra-/postoperative outcomes for patients undergoing relaparotomy compared to patients undergoing primary laparotomy.

Pylorus Resection Does Not Reduce Delayed Gastric Emptying After Partial Pancreatoduodenectomy: A Blinded Randomized Controlled Trial (PROPP Study, DRKS00004191).

Objectives: The aim of this study was to investigate the effect of pylorus resection on postoperative delayed gastric emptying (DGE) after partial pancreatoduodenectomy (PD).

Background: PD is the standard treatment for tumors of the pancreatic head. Preservation of the pylorus has been widely accepted as standard procedure.

Teres Ligament Patch Reduces Relevant Morbidity After Distal Pancreatectomy (the DISCOVER Randomized Controlled Trial).

Objective: The aim of this study was to analyze the impact of teres ligament covering on pancreatic fistula rate after distal pancreatectomy (DP).

Background: Postoperative pancreatic fistula (POPF) represents the most significant complication after DP. Retrospective studies suggested a benefit of covering the resection margin by a teres ligament patch.

Effectiveness of triclosan-coated PDS Plus versus uncoated PDS II sutures for prevention of surgical site infection after abdominal wall closure: the randomised controlled PROUD trial.

Background: Postoperative surgical site infections are one of the most frequent complications after open abdominal surgery, and triclosan-coated sutures were developed to reduce their occurrence. The aim of the PROUD trial was to obtain reliable data for the effectiveness of triclosan-coated PDS Plus sutures for abdominal wall closure, compared with non-coated PDS II sutures, in the prevention of surgical site infections.

Methods: This multicentre, randomised controlled group-sequential superiority trial was done in 24 German hospitals.

Insights into surgical trials: methodological challenges and solutions.

Background: Novel surgical methods and procedures used to be introduced by experts and were established depending on the corresponding success that was noted. Surgical trials representing evidence level 1b were and still are called into question for different reasons. Prospective randomized controlled trials comparing various surgical strategies that were conducted over the past 11 years in the clinical trial unit in the department of general, visceral, and transplantation surgery of the University of Heidelberg pointed out problems as well as possible solutions for surgical trials' characteristics.

Prevention of abdominal wound infection (PROUD trial, DRKS00000390): study protocol for a randomized controlled trial.

Background: Wound infection affects a considerable portion of patients after abdominal operations, increasing health care costs and postoperative morbidity and affecting quality of life. Antibacterial coating has been suggested as an effective measure to decrease postoperative wound infections after laparotomies. The INLINE metaanalysis has recently shown the superiority of a slowly absorbable continuous suture for abdominal closure; with PDS plus® such a suture has now been made available with triclosan antibacterial coating.