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9. Randomized controlled trial of nasogastric tube use after esophagectomy : study protocol for the kinetic trial

Author

Hedberg, Jakob, Sundbom, Magnus, Edholm, David, Aahlin, Eirik Kjus, Szabo, Eva, Lindberg, Fredrik, Johnsen, Gjermund, Tidemann Førland, Dag, Johansson, Jan, Kauppila, Joonas H, Svendsen, Lars Bo, Nilsson, Magnus, Lindblad, Mats, Lagergren, Pernilla, Larsen, Michael Hareskov, Åkesson, Oscar, Löfdahl, Per, Mala, Tom, Achiam, Michael Patrick, Hedberg, Jakob, Sundbom, Magnus, Edholm, David, Aahlin, Eirik Kjus, Szabo, Eva, Lindberg, Fredrik, Johnsen, Gjermund, Tidemann Førland, Dag, Johansson, Jan, Kauppila, Joonas H, Svendsen, Lars Bo, Nilsson, Magnus, Lindblad, Mats, Lagergren, Pernilla, Larsen, Michael Hareskov, Åkesson, Oscar, Löfdahl, Per, Mala, Tom, and Achiam, Michael Patrick

Abstract

Esophagectomy is a complex and complication laden procedure. Despite centralization, variations in perioparative strategies reflect a paucity of evidence regarding optimal routines. The use of nasogastric (NG) tubes post esophagectomy is typically associated with significant discomfort for the patients. We hypothesize that immediate postoperative removal of the NG tube is non-inferior to current routines. All Nordic Upper Gastrointestinal Cancer centers were invited to participate in this open-label pragmatic randomized controlled trial (RCT). Inclusion criteria include resection for locally advanced esophageal cancer with gastric tube reconstruction. A pretrial survey was undertaken and was the foundation for a consensus process resulting in the Kinetic trial, an RCT allocating patients to either no use of a NG tube (intervention) or 5 days of postoperative NG tube use (control) with anastomotic leakage as primary endpoint. Secondary endpoints include pulmonary complications, overall complications, length of stay, health related quality of life. A sample size of 450 patients is planned (Kinetic trial: https://www.isrctn.com/ISRCTN39935085). Thirteen Nordic centers with a combined catchment area of 17 million inhabitants have entered the trial and ethical approval was granted in Sweden, Norway, Finland, and Denmark. All centers routinely use NG tube and all but one center use total or hybrid minimally invasive-surgical approach. Inclusion began in January 2022 and the first annual safety board assessment has deemed the trial safe and recommended continuation. We have launched the first adequately powered multi-center pragmatic controlled randomized clinical trial regarding NG tube use after esophagectomy with gastric conduit reconstruction.

Published
2024
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10. Randomized controlled trial of nasogastric tube use after esophagectomy:study protocol for the kinetic trial

Author

Hedberg, Jakob, Sundbom, Magnus, Edholm, David, Aahlin, Eirik Kjus, Szabo, Eva, Lindberg, Fredrik, Johnsen, Gjermund, Førland, Dag Tidemann, Johansson, Jan, Kauppila, Joonas H., Svendsen, Lars Bo, Nilsson, Magnus, Lindblad, Mats, Lagergren, Pernilla, Larsen, Michael Hareskov, Åkesson, Oscar, Löfdahl, Per, Mala, Tom, Achiam, Michael Patrick, Hedberg, Jakob, Sundbom, Magnus, Edholm, David, Aahlin, Eirik Kjus, Szabo, Eva, Lindberg, Fredrik, Johnsen, Gjermund, Førland, Dag Tidemann, Johansson, Jan, Kauppila, Joonas H., Svendsen, Lars Bo, Nilsson, Magnus, Lindblad, Mats, Lagergren, Pernilla, Larsen, Michael Hareskov, Åkesson, Oscar, Löfdahl, Per, Mala, Tom, and Achiam, Michael Patrick

Abstract

Esophagectomy is a complex and complication laden procedure. Despite centralization, variations in perioparative strategies reflect a paucity of evidence regarding optimal routines. The use of nasogastric (NG) tubes post esophagectomy is typically associated with significant discomfort for the patients. We hypothesize that immediate postoperative removal of the NG tube is non-inferior to current routines. All Nordic Upper Gastrointestinal Cancer centers were invited to participate in this open-label pragmatic randomized controlled trial (RCT). Inclusion criteria include resection for locally advanced esophageal cancer with gastric tube reconstruction. A pretrial survey was undertaken and was the foundation for a consensus process resulting in the Kinetic trial, an RCT allocating patients to either no use of a NG tube (intervention) or 5 days of postoperative NG tube use (control) with anastomotic leakage as primary endpoint. Secondary endpoints include pulmonary complications, overall complications, length of stay, health related quality of life. A sample size of 450 patients is planned (Kinetic trial: https://www.isrctn.com/ISRCTN39935085). Thirteen Nordic centers with a combined catchment area of 17 million inhabitants have entered the trial and ethical approval was granted in Sweden, Norway, Finland, and Denmark. All centers routinely use NG tube and all but one center use total or hybrid minimally invasive-surgical approach. Inclusion began in January 2022 and the first annual safety board assessment has deemed the trial safe and recommended continuation. We have launched the first adequately powered multi-center pragmatic controlled randomized clinical trial regarding NG tube use after esophagectomy with gastric conduit reconstruction.

Published
2024

11. Suboptimal Weight Loss 13 Years After Roux-en-Y Gastric Bypass Is Associated with Blunted Appetite Response

Author

Nymo, Siren, Lundanes, Julianne, Eriksen, Kevin, Aukan, Marthe, Rehfeld, Jens Frederik, Holst, Jens Juul, Johnsen, Gjermund, Græslie, Hallvard, Kulseng, Bård, Sandvik, Jorunn, Martins, Catia, Nymo, Siren, Lundanes, Julianne, Eriksen, Kevin, Aukan, Marthe, Rehfeld, Jens Frederik, Holst, Jens Juul, Johnsen, Gjermund, Græslie, Hallvard, Kulseng, Bård, Sandvik, Jorunn, and Martins, Catia

Abstract

PURPOSE: Bariatric surgery remains the most efficient treatment to achieve a sustained weight loss. However, a large proportion of patients experience suboptimal weight loss (SWL). The exact mechanisms involved remain to be fully elucidated, but the homeostatic appetite control system seems to be involved. The aim of this study was, therefore, to compare the plasma concentration of gastrointestinal hormones, and appetite ratings, between those experiencing SWL and optimal weight loss (OWL) after Roux-en-Y gastric bypass (RYGB).MATERIALS AND METHODS: Fifty participants from the Bariatric Surgery Observation Study (BAROBS) experiencing either SWL or OWL (< or ≥ 50% of excess weight loss (EWL), respectively) > 13 years post-RYGB were compared to 25 non-surgical controls. Plasma concentrations of acylated ghrelin (AG), total glucagon-like peptide-1 (GLP-1), total peptide YY (PYY), cholecystokinin (CCK), and subjective ratings of hunger, fullness, desire to eat (DTE), and prospective food consumption (PFC) were assessed in the fasting and postprandial (area under the curve (AUC)) states.RESULTS: Those experiencing OWL presented with higher basal AG and GLP-1 iAUC, and lower AG iAUC compared with SWL and controls. Additionally, both bariatric groups presented with higher PYY and CCK iAUC compared to controls. PFC tAUC was also lower in OWL compared to the SWL group. Total weight loss was positively correlated with GLP-1 tAUC and negatively correlated with fasting and tAUC DTE and PFC tAUC.CONCLUSIONS: SWL > 13 years post-RYGB is associated with lower basal ghrelin, as well as a weaker satiety response to a meal. Future studies should investigate the causality of these associations.

Published
2024

13. Endoluminal treatment for Zenker's diverticulum – a population-based observational study.

Author

Søfteland, Eirik Østensen, Aasebøstøl, Anne Kristin, Johnsen, Gjermund, and Bringeland, Erling Audun

Subjects
DIVERTICULUM, NASAL surgery, GASTROINTESTINAL surgery, LASER surgery, SCIENTIFIC observation, EAR infections, ENDOSCOPIC surgery, POSTOPERATIVE nausea & vomiting
Abstract

Zenker's diverticulum is a false diverticulum arising in the oesophago-pharyngeal junction. It may cause symptoms like dysphagia and regurgitation. In Central Norway, treatment is centralized to St. Olavs hospital, either as an endoscopic stapled oesophago-diverticulostomy procedure at the Department of Gastrointestinal Surgery or as laser diverticulostomy at the Department of Ear, Nose and Throat Surgery, depending on diverticulum size. Retrospective, population-based, study from 2001–2020 on patients treated for Zenker's diverticulum, at the time with a rigid endoscopic approach. Patients were identified through the in-hospital register for operations. The two treatment groups were compared on relevant pre-, intra-, and postoperative variables by review of the individual patient records. 78 consecutive patients, 36 at Dept. of Ear, Nose and Throat Surgery and 42 at Dept. of Gastrointestinal Surgery, were treated with a total of 104 interventions. Crude incidence for a surgery-demanding Zenker's diverticulum was 0.57 per 100 000 per year. The Dept. of Ear, Nose and Throat Surgery administered significantly less often prophylactic antibiotics than the Dept. of Gastrointestinal Surgery (p < 0.001), administered more frequently intraoperative dexamethasone (p < 0.001), and had significantly more postoperative infections (19.6% vs 3.4%, p = 0.01). No procedure-related mortality was registered. Although no standardized follow-up took place, at a median of 119 months elapsed, observed clinical recurrence was 35% for the endostapler treatment and 51% for the laser treatment procedure. Both rigid endoscopic stapled oesophago-diverticulostomy and laser diverticulostomy are safe treatments for Zenker's diverticulum, however with a substantial risk of recurrence. [ABSTRACT FROM AUTHOR]

Published
2024
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14. Surgical Morbidity and Mortality From the Multicenter Randomized Controlled NeoRes II Trial: Standard Versus Prolonged Time to Surgery After Neoadjuvant Chemoradiotherapy for Esophageal Cancer

Author

Nilsson, Klara, Klevebro, Fredrik, Rouvelas, Ioannis, Lindblad, Mats, Szabo, Eva, Halldestam, Ingvar, Smedh, Ulrika, Wallner, Bengt, Johansson, Jan, Johnsen, Gjermund, Aahlin, Eirik Kjus, Johannessen, Hans-Olaf, Hjortland, Geir Olav, Bartella, Isabel, Schröder, Wolfgang, Bruns, Christiane, and Nilsson, Magnus

Published
2020
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17. 336. IMPACT OF TIME TO SURGERY AFTER CHEMORADIOTHERAPY ON TUMOR REGRESSION AND SURVIVAL IN THE MULTICENTER RANDOMIZED CONTROLLED NEORES II TRIAL

Author

Nilsson, Klara, primary, Klevebro, Fredrik, additional, Sunde, Berit, additional, Rouvelas, Ioannis, additional, Lindblad, Mats, additional, Szabo, Eva, additional, Halldestam, Ingvar, additional, Smedh, Ulrika, additional, Wallner, Bengt, additional, Johansson, Jan, additional, Borg, David, additional, Johnsen, Gjermund, additional, Aalin, Eirik Kjus, additional, Johannessen, Hans-Olaf, additional, von Döbeln, Gabriella Alexandersson, additional, Hjortland, Geir Olav, additional, Al-Haidari, Ghazwan, additional, Quaas, Alexander, additional, Wang, Naining, additional, Bartella, Isabel, additional, Bruns, Christiane, additional, Schröder, Wolfgang, additional, and Nilsson, Magnus, additional

Published
2022
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18. 257. DIFFERENCES IN PERIOPERATIVE STRATEGIES IN ESOPHAGEAL CANCER TREATMENT IN 13 NORDIC UNIVERSITY HOSPITALS CALL FOR HIGH-LEVEL EVIDENCE REGARDING THESE PRACTICES

Author

Achiam, Michael, primary, Nilsson, Magnus, additional, Åkesson, Oscar, additional, Johansson, Jan, additional, Edholm, David, additional, Lindblad, Mats, additional, Szabo, Eva, additional, Sundbom, Magnus, additional, Lindberg, Fredrik, additional, Larsen, Michael Hareskov, additional, Aahlin, Eirik Kjus, additional, Mala, Tom, additional, Johannessen, Hans-Olaf, additional, Johnsen, Gjermund, additional, Kauppila, Joonas, additional, Löfdahl, Per, additional, and Hedberg, Jakob, additional

Published
2022
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20. The Effect of Roux-en-Y Gastric Bypass on Non-Alcoholic Fatty Liver Disease Fibrosis Assessed by FIB-4 and NFS Scores—An 11.6-Year Follow-Up Study

Author

Sandvik, Elfrid Christine Smith, primary, Aasarød, Kristin Matre, additional, Johnsen, Gjermund, additional, Hoff, Dag Arne Lihaug, additional, Kulseng, Bård, additional, Hyldmo, Åsne Ask, additional, Græslie, Hallvard, additional, Nymo, Siren, additional, Sandvik, Jorunn, additional, and Fossmark, Reidar, additional

Published
2022
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24. Characteristics of Patients Reporting Presumed Problematic Drinking Behavior After Gastric Bypass: Exploring Long-Term Data From the BAROBS Study

Author

Strømmen, Magnus, primary, Klöckner, Christian Andreas, additional, Bjerkan, Kirsti Kverndokk, additional, Græslie, Hallvard, additional, Hoff, Dag Arne Lihaug, additional, Johnsen, Gjermund, additional, Kulseng, Bård, additional, Mårvik, Ronald, additional, Nymo, Siren, additional, and Sandvik, Jorunn, additional

Published
2021
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30. What causes treatment failure - the patient, primary care, secondary care or inadequate interaction in the health services?

Author

Lange Ove, Johnsen Gjermund, Førre Sigurd, Blix Ivar, Farup Per G, Johannessen Rune, and Petersen Hermod

Subjects
Public aspects of medicine, RA1-1270
Abstract

Abstract Background Optimal treatment gives complete relief of symptoms of many disorders. But even if such treatment is available, some patients have persisting complaints. One disorder, from which the patients should achieve complete relief of symptoms with medical or surgical treatment, is gastroesophageal reflux disease (GERD). Despite the fact that such treatment is cheap, safe and easily available; some patients have persistent complaints after contact with the health services. This study evaluates the causes of treatment failure. Methods Twelve patients with GERD and persistent complaints had a semi-structured interview which focused on the patients' evaluation of treatment failure. The interviews were taped, transcribed and evaluated by 18 physicians, (six general practitioners, six gastroenterologists and six gastrointestinal surgeons) who completed a questionnaire for each patient. The questionnaires were scored, and the relative responsibility for the failure was attributed to the patient, primary care, secondary care and interaction in the health services. Results Failing interaction in the health services was the most important cause of treatment failure, followed by failure in primary care, secondary care and the patient himself; the relative responsibilities were 35%, 28%, 27% and 10% respectively. There was satisfactory agreement about the causes between doctors with different specialities, but significant inter-individual differences between the doctors. The causes of the failures differed between the patients. Conclusions Treatment failure is a complex problem. Inadequate interaction in the health services seems to be important. Improved communication between parts of the health services and with the patients are areas of improvement.

Published
2011
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31. Neuroendocrine differentiation in human gastric carcinoma

Author

Waldum, Helge L., Aase, Steinar, Kvetnoi, Igor, Brenna, Eiliv, Sandvik, Arne K., Syversen, Unni, Johnsen, Gjermund, Vatten, Lars, and Polak, Julia M.

Subjects
Stomach cancer -- Physiological aspects, Tumor markers, Health
Published
1998

32. Optimal timing of assessment tasks depending on experience level of surgical trainees.

Author

Våpenstad, Cecilie, Fagertun Hofstad, Erlend, Eivind Bernstein, Tor, Aadahl, Petter, Johnsen, Gjermund, and Mårvik, Ronald

Subjects
ABILITY, CLINICAL competence, ENDOSCOPIC surgery, EXPERTISE, HOSPITAL medical staff, LAPAROSCOPIC surgery, MEDICAL personnel, MEDICAL students, WORK measurement, TRAINING, TASK performance, ENTRY level employees, MULTITRAIT multimethod techniques, MOTION capture (Human mechanics), WORK experience (Employment)
Abstract

Introduction: Box trainers with motion analysis are important add-ons to surgical training and skills assessment outside the operating room, given that they exhibit construct validity. Material and methods: Four different tasks were tested for construct validity on a new laparoscopic box trainer with integrated motion analysis. Tracking data from the simulator were analyzed for eighteen parameters per task using an in-house software comparing participants with three different experience levels. Results: In total, ten novices, 22 intermediates and 16 experts enrolled. No or limited significant differences were found for the peg picker and rope race. For the precision cutting task 12 parameters showed significant difference between novices and intermediates, 14 between novices and experts and one between intermediates and experts. For the suture task the corresponding results were one, 15 and six. Conclusions: The precision cutting and suture task both showed construct validity for many of the parameters. While the precision cutting task distinguished best between novices and the other two groups, the suture task distinguished best between experts and the other two groups. These results show the importance of the timing of an assessment task, and that an assessment task might have limited value if experience levels are not considered. [ABSTRACT FROM AUTHOR]

Published
2020
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33. PS02.120: NEOADJUVANT CHEMOTHERAPY VERSUS NEOADJUVANT CHEMORADIOTHERAPY FOR CANCER OF THE OESOPHAGUS OR GASTRO-OESOPHAGEAL JUNCTION: LONG-TERM RESULTS

Author

Von Döbeln, Gabriella, primary, Klevebro, Fredrik, additional, Jacobsen, Anne-Birgitte, additional, Hilmer Nielsen, Niels, additional, Johnsen, Gjermund, additional, Hatlevoll, Ingunn, additional, Idar Glenjen, Nils, additional, Friesland, Signe, additional, Lundell, Lars, additional, and Nilsson, Magnus, additional

Published
2018
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35. Mo1945 Intragastric Injection of Botulinum Toxin a to Treat Obesity: Mechanism of Action and a Randomized, Double-Blind, Placebo-Controlled Phase II Trial With Open-Label Extension Study

Author

Chen, Duan, primary, Olsen, Magnus K., additional, Strommen, Magnus, additional, Johannessen, Helene, additional, Bjoru, Hege T., additional, Salater, Sissel, additional, Johnsen, Gjermund, additional, Marvik, Ronald, additional, Zhao, Chun-Mei, additional, and Kulseng, Baard, additional

Published
2016
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36. Erratum to: Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the VBLOC DM2 Study

Author

Shikora, Scott A., primary, Toouli, James, additional, Herrera, Miguel F., additional, Kulseng, Bård, additional, Brancatisano, Roy, additional, Kow, Lilian, additional, Pantoja, Juan P., additional, Johnsen, Gjermund, additional, Brancatisano, Anthony, additional, Tweden, Katherine S., additional, Knudson, Mark B., additional, and Billington, Charles J., additional

Published
2015
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37. Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the VBLOC DM2 Study

Author

Shikora, Scott A., primary, Toouli, James, additional, Herrera, Miguel F, additional, Kulseng, Bård, additional, Brancatisano, Roy, additional, Kow, Lilian, additional, Pantoja, Juan P., additional, Johnsen, Gjermund, additional, Brancatisano, Anthony, additional, Tweden, Katherine S., additional, Knudson, Mark B., additional, and Billingto, Charles J., additional

Published
2015
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46. ET-103 Vagal blocking for the treatment of obesity delivered using the fully implantable maestro rechargeable system: 12 month results

Author

Kow, Lilian, primary, Herrera, Miguel, additional, Kulseng, Baard, additional, Brancatisano, Roy, additional, Zulewski, Henryk, additional, Brancatisano, Anthony, additional, Pantoja, Juan Pablo, additional, Johnsen, Gjermund, additional, Frey, Daniel M., additional, Tweden, Katherine S., additional, and Toouli, James, additional

Published
2011
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47. P-72: Intermittent vagal blockade with an implantable device improves glycemic control in obese subjects with type 2 diabetes

Author

Herrera, Miguel F., primary, Brancatisano, Roy, additional, Keller, Ulrich, additional, Kulseng, Baard, additional, Toouli, James, additional, Brancatisano, Anthony, additional, Frey, Daniel M., additional, Kow, Lillian, additional, Johnsen, Gjermund, additional, Pantoja, Juan P., additional, Bhole, Deepak, additional, Carey, Robert M., additional, Tweden, Katherine S., additional, Vollmer, Mark, additional, Wilson, Richard R., additional, and Billington, Charles J., additional

Published
2009
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48. P-81: Intermittent vagal blockade with an implantable device improves blood pressure in obese subjects

Author

Toouli, James, primary, Brancatisano, Roy, additional, Keller, Ulrich, additional, Kulseng, Baard, additional, Brancatisano, Anthony, additional, Frey, Daniel M., additional, Kow, Lillian, additional, Johnsen, Gjermund, additional, Bhole, Deepak, additional, Billington, Charles J., additional, Tweden, Katherine S., additional, Vollmer, Mark, additional, Wilson, Richard R., additional, and Carey, Robert M., additional

Published
2009
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50. PL-42: Vagal blocking for obesity control (VBLOCTM): Ongoing comparison of weight loss with two generations of an active, implantable medical device

Author

Toouli, James, primary, Kulseng, Baard, additional, Keller, Ulrich, additional, Kow, Lilian, additional, Marvik, Ronald, additional, Johnsen, Gjermund, additional, Frey, Daniel M., additional, Tweden, Katherine S., additional, Wilson, Richard R., additional, Billington, Charles J., additional, and Moody, Frank G., additional

Published
2008
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