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Spinal Bupivacaine/Morphine in laparoscopic gastro-intestinal surgery

The objective of this study is to determine if a single spinal shot of morphine can decrease post-operative opioid-use, and thereby decrease opioid side-effects and lead to a quicker recovery after surgery.

Neo-adjuvant chemotherapy followed by surgery versus surgery alone in high-risk patients with resectable colorectal liver metastases ;The CHARISMA randomized multicenter clinical trial

The primary study objective is to compare the efficacy, as assessed by overall survival, of surgery and neo-adjuvant chemotherapy to surgery alone in patients with resectable liver metastases of colorectal cancer and a high clinical risk score.…

A Randomized Controlled Multicenter Study of an Incisionless Operating Platform for Primary Obesity vs. Diet-Exercise alone: The MILEPOST Study

The primary objective of this study is:* To evaluate the safety and effectiveness of the g-Cath* EZ Delivery Catheter with Snowshoe Suture Anchors* gastric procedure as an weight loss intervention compared to diet and exercise only.A key secondary…

Semi-mechanical versus hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for esophageal cancer; the SHARE study

The primary objective of this study is to compare a semi-mechanical with a hand sewn cervical anastomosis after esophagectomy with gastric tube reconstruction for cancer.

Endoluminal fundoplication with the Esophyx*-device versus proton-pump-inhibition in treatment of Gastro-esophageal reflux disease (GERD).

The purpose of this prospective randomized controlled trial is to demonstrate that the EsophyX-TIF procedure will be more effective than PPI therapy as a short and long-term treatment of GERD.

A phase III randomized study evaluating surgery of residual disease in patients with metastatic gastro-intestinal stromal tumor responding to Imatinib mesylate.

The primary objective of this study is to evaluate whether surgery of residual disease in patients iwth advanced GIST responding to Imatinib improves the progression free survival.The secondary objective is to correlate the pharmacokinetics of…

Forward viewing ultrasonic endoscope versus standard oblique viewing ultrasonic endoscope in transmural drainage of pancreatic fluid collections: A randomized controlled trial

To compare endoscopic pancreatic fluid collection drainage using a standard oblique-viewing US endoscope versus a prototype forward viewing ultrasonic endoscope with emphasis on ease of endoscopic drainage measured by procedural time.

Intensive endoscopic therapy versus conventional treatment for untreated benign anastomotic strictures after esophagectomy: a pilot and randomized controlled trial

To prolong the dysphagia-free period and to reduce the number of endoscopic dilations for patients with newly diagnosed, untreated benign anastomotic strictures after esophagectomy.

Second and third look laparoscopy in pT4 colon cancer patients for early detection of peritoneal metastases; the COLOPEC 2 randomized multicentre trial.

The primary aim of this study is to determine the added value of third look DLS to detect PM at a clinically occult stage following a negative second look DLS.

Minimally invasive versus open pancreato-duodenectomy for pancreatic and peri-ampullary neoplasm (DIPLOMA-2): an international multicenter patient-blinded randomized controlled trial

The aim of DIPLOMA-2 is to compare MIPD with OPD regarding post-operative complications (non-inferiority) and time to functional recovery (superiority) for pancreatic and peri-ampullary neoplasm in high-volume centers in an enhanced recovery setting…

Treatment of PERitoneal dissemination in Stomach Cancer patients with
cytOreductive surgery and hyperthermic intraPEritoneal chemotherapy: the
PERISCOPE II study

This study has been transitioned to CTIS with ID 2023-510159-53-01 check the CTIS register for the current data. The primary aim of this study is to compare the overall survival between gastric cancer patients with limited peritoneal carcinomatosis…

COLOR III: A multicentre randomised clinical trial comparing transanal versus laparoscopic total mesorectal excision for rectal cancer.

In attempt to improve the quality of the TME procedure in low rectal cancer and further improve morbidity the TaTME has been developed, in which the rectum is dissected transanally according to TME principles. First series have been described since…

Rectal preserving treatment for early rectal cancer. A multi-centred, partially randomised patient preference trial of radical surgery versus adjuvant chemoradiotherapy after local excision for early rectal cancers.

This study has been transitioned to CTIS with ID 2024-517410-15-01 check the CTIS register for the current data. The aim of this study is to determine the oncological safety, treatment related morbidity, and the functional outcome of local excision…

Efficacy, safety and tolerability of a bowel cleansing preparation (Eziclen®/Izinova®)
in paediatric subjects undergoing colonoscopy: a Phase III, multicentre, randomised, comparative study versus Klean-Prep® (PEG-Electrolytes), administered on the day before colonoscopy,
Investigator-blinded, non-inferiority in adolescents of 12 to 17 years of age (inclusive) > 40 kg.

Primary objective:To demonstrate that Eziclen, given on the day before colonoscopy has non-inferior efficacy to Klean-Prep on colon cleansing in adolescents aged 12 to 17 years (inclusive) with a body weight > 40 kg, scheduled to undergo a…

Colonic stenting as bridge to surgery versus emergency surgery for management of acute left-sided malignant colonic obstruction: a multicenter randomized trial (Stent-in II study)

To compare colonic stenting followed by elective surgery with emergency surgery for the management of acute left-sided malignant colonic obstruction in terms of health-related quality of life, morbidity and mortality.

Laparoscopic versus robot-assisted left-sided pancreatectomy for benign and pre-malignant lesions (DIPLOMA-3): an international multicenter patient-blinded randomized controlled trial

To compare L-MILP with R-MILP for benign and pre-malignant lesions of the pancreas in high-volume centers, regarding:1. Peri- and postoperative outcomes in terms of COMPOS-panc left score, for non-inferiority2. Total hospital-related costs, for…

Distal pancreatectomy, minimally invasive or open, for malignancy (DIPLOMA)

To compare MIDP with ODP regarding radical resection rate) for pancreatic ductal adenocarcinoma (PDAC) in the pancreatic body or tail.

Longterm outcome of biological mesh closure of the pelvic floor after extralevator abdominoperineal resection for rectal cancer.

The aim of this study is to determine the cost-effectiveness of pelvic floor reconstruction using a biological mesh afterstandardized eAPR with neo-adjuvant (chemo)radiotherapy.