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A two-center randomized clinical superiority trial of single-anastomosis sleeve ileal bypass versus sleeve gastrectomy for severe obesity: SASSY study protocol.

BACKGROUND: Single-anastomosis sleeve ileal bypass is a novel metabolic bariatric surgery intended to enhance metabolic outcomes and reduce the risk of postoperative complications. Although preliminary outcome data for single-anastomosis sleeve ileal bypass are promising, evidence from adequately powered, randomized head-to-head comparisons is scarce. This trial compares the efficacy and safety of single-anastomosis sleeve ileal bypass versus sleeve gastrectomy in patients with class II obesity (body mass index = 35.0-39.9 kg/m²) with at least one obesity‑related comorbidity or class III obesity (body mass index ⩾40.0 kg/m²). METHODS: This two-center randomized clinical superiority trial enrolls patients eligible for metabolic bariatric surgery at two specialized Norwegian centers. Included patients are randomly assigned (1:1) to either single-anastomosis sleeve ileal bypass or sleeve gastrectomy with standardized perioperative treatment and care. The primary endpoint is the between-group difference in change in body mass index from baseline to 2 years after single-anastomosis sleeve ileal bypass versus sleeve gastrectomy. Secondary endpoints include additional weight loss outcomes, the prevalence of gastroesophageal reflux disease, surgical and postoperative complications, obesity-related comorbidities, nutritional status, bone mineral density, gastrointestinal symptoms, quality of life, and rates of revisional and conversion surgery. All endpoints will be evaluated at 2 and 5 years after surgery. Statistical analyses utilize linear mixed models and analysis of covariance within an intention-to-treat framework. DISCUSSION: This trial will provide high-level evidence with robust and comparative outcome data on single-anastomosis sleeve ileal bypass and sleeve gastrectomy, aiming to clarify the clinical utility of single-anastomosis sleeve ileal bypass and inform surgical practice. Findings will address gaps in medium- and long-term evidence regarding weight loss, safety, comorbidity resolution, and quality of life following single-anastomosis sleeve ileal bypass.

Humans↗

THE IMMEDIATE RESULTS OF OPERATIONS FOR DUODENAL ULCER: A COMPARATIVE STUDY OF THE MORBIDITY AND MORTALITY OF VAGOTOMY AND PYLOROPLASTY VERSUS SUBTOTAL GASTRECTOMY.

Immediate postoperative results of vagotomy and pyloroplasty were compared with those of subtotal gastrectomy. Ulcer recurrence rate and the long-term complications of the two procedures were not studied. Age and sex distribution, and preoperative indications in the two groups of patients were almost identical. Vagotomy and pyloroplasty has gradually superseded subtotal gastrectomy at St. Michael's Hospital, Toronto. One hundred and seventy vagotomy and drainage procedures were compared with 173 subtotal gastric resections performed over a five-year period. There were 39 postoperative complications and five deaths in the subtotal gastrectomy group, an overall mortality of 2.8% and an elective mortality of 2.4%. In the vagotomy and pyloroplasty group there were 31 postoperative complications and two deaths, an overall mortality of 1.2% and an elective mortality of zero. Vagotomy and pyloroplasty is a relatively safe procedure, associated with fewer complications, shorter hospital stay and a lower mortality than subtotal gastrectomy.

Biometry↗

[Use of a nasojejunal tube after total gastrectomy: a multicentre prospective randomised trial].

Dehiscence of the Roux-en-Y oesophagojejunostomy after total gastrectomy is an infrequent complication that may lead to severe morbidity and even death when it occurs. A prospective multicentre randomised trial was designed to assess the need for routine nasojejunal decompression after total gastrectomy with Roux-en-Y oesophagojejunostomy in patients with gastric cancer. Two hundred and thirty-seven patients undergoing total gastrectomy for gastric cancer were randomly assigned to placement of a nasojejunal tube (NJT group) or not (no-NJT group). The patients were monitored for postoperative complications, mortality and postoperative course. The rates of anastomotic leaks were similar in both groups (NJT group, 6.9%; no-NJT group 5.8%) as were the rates of major postoperative complications (25.9% and 21.5%, respectively) and the overall postoperative mortality rates (0.9% and 0.8%, respectively). There were no differences between the two groups in mean time +/- SD to passage of flatus (4.6 +/- 1.3 and 4.5 +/- 1.7 days, respectively) and to starting a liquid diet (7.8 +/- 2.6 and 7.7 +/- 1.6 days, respectively), or in mean +/- SD postoperative hospital stay (13.5 +/- 7.3 and 13.9 +/- 10.9 days, respectively), mean postoperative pain and postoperative abdominal distension. The results of this study suggest that routine placement of an NJT after Roux-en-Y oesophagojejunostomy is unnecessary in elective total gastrectomy for gastric cancer.

Adolescent↗

Development of Wernicke-Korsakoff syndrome after long intervals following gastrectomy.

BACKGROUND: Surgical exclusion of portions of the gastrointestinal tract is a predisposing risk factor for the development of Wernicke-Korsakoff syndrome. When this disease occurs, it is usually within weeks after the gastrointestinal surgery. However, it is not well known that Wernicke-Korsakoff syndrome may occur after a long latent interval following gastrectomy. SETTING: A research-oriented hospital. PATIENTS: Three patients without a history of alcoholism or dietary deprivation developed Wernicke-Korsakoff syndrome 2 to 20 years after undergoing gastrectomy. In these patients, minor changes in dietary habit led to the development of Wernicke-Korsakoff syndrome. CONCLUSIONS: In addition to a long-standing latent deficiency in thiamin levels due to defective absorption following gastrectomy or gastrojejunostomy, other minor factors that may influence the intake of thiamin and the need for thiamin in subjects who have undergone gastrectomy may cause a state of thiamin deficiency resulting in Wernicke-Korsakoff syndrome. Results from our study indicate that the following measures are mandatory: educating patients about proper dietary habits, carefully monitoring their thiamin intake, recognizing Wernicke-Korsakoff syndrome early, and treating it immediately with appropriate measures.

Aged↗

Indications for a pylorus-preserving gastrectomy for gastric cancer with proper muscle invasion.

HYPOTHESIS: Our previous demonstrations of the feasibility of a pylorus-preserving gastrectomy with a wider-scope lymphadenectomy for early gastric cancer (GC) have raised the possibility of applying pylorus-preserving gastrectomy to a broader segment of GC patients, such as those having GC with invasion extending into the proper muscle layer (GCpm). DESIGN: Case series. SETTING: Tertiary care center. PATIENTS: This study comprised 107 patients with solitary primary GCpm located in the middle or lower third of the stomach. INTERVENTION: All patients underwent gastrectomy, using at least the former D2 dissection of the American Joint Committee on Cancer. MAIN OUTCOME MEASURES: Patterns and sites of nodal involvement were analyzed in relationship to other clinicopathologic characteristics, including preoperative and intraoperative evaluations of tumor depth (cT), nodal involvement (cN), and serosal involvement. The conditions required were serosal negativity and measurements less than or equal to cT2 cN0 with histologic proof of node negativity, or if positive, the positive nodes had to be confined to the first or selective second tier. The selective second-tier nodes were defined as those along the left gastric, common hepatic, and celiac arteries. RESULTS: The factors favoring node negativity were serosal negativity, cN0, or both. For tumors that were serosal-negative and less than or equal to cT2 cN0 to meet the above conditions, a tumor in the middle third of the stomach had to be less than or equal to 2 cm in the maximum diameter, and that in the lower third could be any size. No patients with serosal negativity and cT2 cN0 GCpm less than or equal to 2 cm in diameter died of cancer or had positive nodes beyond the selective second tier. CONCLUSIONS: Considering the required distance between the pyloric ring and distal margin of the tumor to avoid a positive resection margin, pylorus-preserving gastrectomy with a selective second-tier node dissection is optimal for tumors that are serosal negative, less than or equal to cT2 cN0, and less than or equal to 2 cm in maximum diameter when located in the middle or lower third of the stomach.

Aged↗

The effect of a segmental gastrectomy with proximal gastric vagotomy on gastric secretion and gastric emptying.

Gastric acid secretory responses to graded doses of pentagastrin were measured in duodenal ulcer patients before and after either proximal gastric vagotomy (17 patients) or proximal gastric vagotomy associated with a segmental gastrectomy (11 patients). Calculated maximal output of acid and responsiveness of the acid-secreting cells to pentagastrin were reduced by both operations; after surgery, maximal acid output was lower in the proximal gastric vagotomy plus segmental gastrectomy group than in the proximal gastric vagotomy group. Gastric emptying of a liquid meal was assessed before and after either proximal vagotomy (13 patients) or proximal gastric vagotomy plus segmental gastrectomy (9 patients). The early phase of emptying was equally accelerated by both operations, and at later stages the emptying was only slightly, but not significantly, faster following proximal gastric vagotomy associated with segmental gastrectomy.

Adolescent↗

Quality of life after gastrectomy in patients with carcinoma of the stomach.

One hundred and fifty patients without recurrence of disease after R2 gastrectomy for carcinoma of the stomach were interviewed to determine their quality of life after surgery. Patients ate less and weighed less but most appeared to be well adjusted and had an optimistic attitude regarding their physical state. There was no evidence of a diminished quality of life in those who had undergone distal partial gastrectomy. These patients had a higher overall food tolerance, body-weight and performance status compared with those treated by total gastrectomy. Considering the satisfactory outcome and the sustained quality of life, radical R2 gastrectomy may be the treatment of choice for carcinoma of the stomach.

Body Weight↗

Prospective study of proximal gastrectomy for early gastric cancer in the upper third of the stomach.

BACKGROUND: Total gastrectomy with D2 dissection is the standard treatment in Japan for early upper-third gastric cancer. The purpose of this study was to confirm the safety and radicality of proximal gastrectomy as an alternative operation. METHODS: Between 1993 and 1999, 45 patients with an apparent primary early gastric cancer in the upper third of the stomach were treated by proximal gastrectomy with jejunal interposition. The spleen was preserved, but the suprapancreatic nodes were cleared. RESULTS: Histology confirmed early gastric cancer in 37 patients while eight had advanced disease. Nodal metastasis was observed in six patients. There was no hospital death and no early postoperative complications. One patient died from nodal recurrence and two from unrelated causes. Two patients had reflux symptoms without endoscopic oesophagitis. Mean weight loss was 11.5 per cent of initial bodyweight. CONCLUSION: Proximal gastrectomy for early upper-third gastric cancer can be performed safely with an excellent cure rate. This procedure deserves further clinical evaluation to assess patients' quality of life.

Adult↗

Techniques of reconstruction after total gastrectomy for cancer.

BACKGROUND: Jejunal pouch formation and restoration of duodenal transit have been suggested for reconstruction after total gastrectomy. Opinions about the clinical value vary. METHODS: The literature was searched for prospective randomized trials comparing reconstructive procedures after total gastrectomy for malignancy. Reports with at least an English or German abstract were included. Immediate results were evaluated in terms of postoperative deaths and complications. Long-term outcome was analysed using trends in bodyweight and quality of life. RESULTS: A total of 19 randomized trials including 866 patients was identified. The operative risk of total gastrectomy was low, with a median mortality rate of 0 (range 0-22) per cent, irrespective of the method of reconstruction. Neither gastric substitution nor restoration of duodenal transit was associated with significant procedure-related complications. Results for specific reconstructions varied considerably within and between individual trials. Jejunal pouch reconstruction, but not restoration of duodenal passage, was associated with improved food intake and a tendency for weight gain in the early postoperative months. A favourable perception of quality of life persisted in the long term in some studies. CONCLUSION: Preservation of duodenal transit offers little clinical benefit. Construction of a small-bowel reservoir after total gastrectomy should be considered to improve early postoperative eating capacity, bodyweight and quality of life.

Body Weight↗

Laparoscopically assisted distal gastrectomy for early gastric cancer in the elderly.

BACKGROUND: Open gastrectomy is associated with increased morbidity and a longer hospital stay than laparoscopically assisted gastrectomy. The aim of this study was to clarify the value of laparoscopically assisted distal gastrectomy (LDG) in the elderly, in whom co-morbid disease is generally more common. METHODS: Forty-five elderly patients (aged 70 years or more) and 57 younger patients who underwent LDG, and 28 elderly patients who underwent open distal gastrectomy (ODG) for early gastric cancer between January 1994 and April 2003 were studied. Demographics and postoperative outcomes were compared. RESULTS: : Co-morbidity was more common in elderly patients than in younger patients who underwent LDG (25 of 45 versus 16 of 57; P = 0.004). The postoperative complication rate, time to solid diet and postoperative hospital stay were similar in these two groups. Elderly patients who underwent LDG had a significantly reduced medical complication rate (two of 45 versus six of 28; P = 0.023), time to first flatus (3.7 versus 4.2 days; P = 0.042), time to solid diet (4.6 versus 5.5 days; P = 0.011) and postoperative hospital stay (16.3 versus 23.9 days; P = 0.011) than elderly patients who had ODG. CONCLUSION: LDG offers particular advantages to elderly patients with early gastric cancer, including rapid return of gastrointestinal function, fewer complications and a shorter hospital stay.

Aged↗

Near-total gastrectomy.

Total gastrectomy has more frequent and serious postoperative complications than subtotal gastrectomy. An esophago-gastric stoma with a side-to-side anastomosis permits a near-total gastrectomy to be undertaken with virtually the same results as a total gastrectomy. This procedure is used for early gastric cancers that have widely spreading, single or multiple lesions, or lesions near the esophago-gastric junction, and for the cure or palliative resection of selected patients with advanced gastric cancer.

Gastrectomy↗

Occurrence of esophageal carcinoma after gastrectomy.

A review of data on 548 patients with primary squamous cell carcinoma revealed that 24 (4.4%) had had gastrectomy. Although the interval of the gastrectomy due to peptic ulcer or gastric cancer and esophageal cancer was 13.4 +/- 7.9 and 5.8 +/- 4.2 years, respectively, this difference was thought to be due only to the occurrence of each disease. The incidence of the occurrence of the lower esophageal cancer after gastrectomy was 29.2%, not significantly higher than the 22.4% incidence of lower esophageal cancer in overall cases. Histopathological investigation of the 13 resected esophageal cancer tissues from gastrectomized patients revealed a mild esophagitis in some cases, with no significant histologic characteristics. Thus esophageal squamous cell carcinoma and previous gastrectomy may be incidentally related.

Aged↗

Different patterns of gamma delta and alpha beta T cell redistribution in the mouse after partial gastrectomy.

BACKGROUND: Stress, including surgical trauma, results in different dysfunctions of the body. In our former experiments on posttraumatic modification of immune response of gastrectomized mice we observed a significant suppression of contact sensitivity. This could be transferred by lymph nodes and spleen T lymphocytes of mice which underwent surgery. MATERIALS AND METHODS: We studied changes in gammadelta and alphabeta T cell numbers in peripheral blood, Peyer's patches, and mesenteric lymph nodes after partial gastrectomy (major operation) and after sham gastrectomy (laparotomy-minor operation) in mice. The number of gammadelta and alphabeta T cells was counted on the FACSTAR cell sorter before and 1, 2, 3, 7, and 14 days after surgery. RESULTS: In our observations there was a significant increase of percentage of gammadelta T cells both in Peyer's patches (1.9 +/- 0.5 to 10.5 +/- 0.3) and in mesenteric lymph nodes (2.7 +/- 0.7 to 8.8 +/- 3.5) on the third day after partial gastrectomy (546 and 322% of control values, respectively). In contrast in gastrectomized mice the number of alphabeta T cells in Peyer's patches (38.4 +/- 6.8 to 21.2 +/- 6.2) and lymph nodes (56.7 +/- 15 to 40.4 +/- 17) was decreased on day 3 (55 and 71% of control values, respectively). There was a decline in both alphabeta (18.1 +/- 8 to 8.2 +/- 1.7) and gammadelta (6.7 +/- 2.8 to 3.9 +/- 2) T cell numbers in peripheral blood on days 1, 3, and 7 (45 and 58% of normal values, respectively). Sham operation had no significant influence on alphabeta and gammadelta T cell numbers. We observed that after leg amputation the number of gammadelta T cells in mesenteric lymph nodes was significantly increased on day 3 (0.8 +/- 0.2 to 7.7 +/- 0.3), 770% of normal. In contrast to this, leg amputation had a negligible effect on T cell counts in Peyer's patches during all periods of observation. CONCLUSIONS: We suggest that the major surgical stress (partial gastrectomy) may disturb the normal cell traffic selectively with increased gammadelta T cell homing in intestinal Peyer's patches and lymph nodes (GALT) and with the cell displacement from peripheral blood to lymphatic organs. The severity and localization of stress may be crucial.

Animals↗

Laparoscopic-assisted vagotomy and distal gastrectomy.

This is a report of the techniques used on and outcome for three patients who underwent laparoscopic-assisted vagotomy and distal gastrectomy for complicated peptic ulcer disease. The first patient had a Billroth I anastomosis in 2 h 42 min with an estimated blood loss of 200 ml. Oral fluids were started on day 3 and the diet progressed to a soft food by day 5. The patient was discharged 11 days after his gastrectomy following a transurethal prostatic resection on day 6. The second patient had a Billroth II anastomosis. The operation was completed in 4 h 40 min with an estimated blood loss of 350 ml. Oral fluids were commenced on the 1st postoperative day and the patient was tolerating a soft diet by day 4. The patient was discharged 5 days after his gastrectomy. The third patient had a Billroth I anastomosis with an estimated blood loss of less than 150 ml. The surgery took 2 h 35 min; the patient was tolerating oral fluids on the first postoperative day and was discharged on the 4th postoperative day on soft diet. Laparoscopic-assisted vagotomy and gastrectomy has the advantages of a minimal-access procedure without the risks of an intracorporeal anastomosis.

Aged↗

The influence of partial gastrectomy on biochemical parameters of bone metabolism and bone density.

Since it has been suggested that gastric resections are followed by changes in bone metabolism, the aim of our study was to determine the biochemical parameters of bone metabolism and radial and lumbar bone density in 15 male ulcus patients treated by partial gastrectomy (Billroth II). Comparing the data with those of a corresponding control group, the lumbar bone density measured by quantitative computed tomography was statistically significantly lower (P less than 0.04) in the patient group, whereas the peripheral bone mass of the distal part of the nondominant forearm measured by single-photon absorptiometry showed no statistically significant difference. In addition, a marked increase in alkaline phosphatase (P less than 0.002) and urinary excretion of hydroxyproline (P less than 0.003) was found in gastrectomy group, whereas the 25-hydroxy-vitamin D levels were found to be significantly decreased (P less than 0.04). Osteocalcin, a biochemical marker for osteoblast activity, and the carboxy-terminal propeptide of type I procollagen (PICP), a marker of collagen formation, were slightly but not significantly higher in gastrectomy-treated patients. The serum parathyroid hormone levels were similar in both groups. As none of the patients had any radiologic evidence of osteopenia, the changes in biochemical parameters of bone metabolism and bone mass in patients who had undergone partial gastrectomy could be a marker of latent bone loss.

Absorptiometry, Photon↗

Successful surgical treatment of secondary Kwashiorkor after total gastrectomy: report of a case.

We report herein the case of a 56-year-old woman who developed secondary Kwashiorkor 9 years after undergoing a total gastrectomy for early gastric cancer. Until she began developing the symptoms of Kwashiorkor, including general fatigue, edema of the face and extremities, anemia, alopecia, and weight loss, she had been leading a normal life post-gastrectomy. Her symptoms were alleviated by total parenteral nutrition (TPN) therapy, but reappeared soon after TPN therapy was discontinued. Therefore, she required several subsequent courses of TPN. In an attempt to permanently resolve the ongoing Kwashiorkor symptoms, reconstructive surgery involving transposition of the jejunum from the previous Graham method to the interposition method was performed 10 years after the initial gastrectomy. After the second operation, her malnutrition was completely alleviated, and she has been in good health for the 8 years since. To our knowledge, there has been no other report of the symptoms of secondary Kwashiorkor after total gastrectomy being alleviated by altering the procedure of reconstruction of the intestinal tract. Thus, we recommend surgical treatment to alter the digestive continuity to a more physiological pathway for selected patients with secondary Kwashiorkor syndrome.

Anastomosis, Surgical↗

"Conservative" treatment of intra-abdominal complications after total gastrectomy with interventional radiological techniques.

Septic complications following total gastrectomy usually require relaparotomy, which is associated with a high operative mortality. Due to the improvement of percutaneous drainage of abdominal abscesses we prefer this therapy for septic complications after total gastrectomy. Among 141 total gastrectomies, 14 patients developed subphrenic abscesses. While 2 patients required relaparotomy, 12 had interventional therapy by sonographically guided drainage and insertion of a pigtail catheter. The catheters were irrigated daily, and the patients received systemic antibiotics. Complete resolution of the abscess cavity was achieved, even in 1 case with simultaneous duodenal stump insufficiency without increasing morbidity. The hospital stay was prolonged for an average of 20 days by this "conservative" treatment. The management of septic complications following total gastrectomy with interventional techniques may reduce the number of operative reinterventions. The indication for such a therapy, however, needs to be evaluated on an individual basis.

Anti-Bacterial Agents↗

[Gastrectomies in the elderly as curative and palliative operations (author's transl)].

Out of 422 patients operated on for gastric carcinoma from 1970-1980, 152 were older than 70 years. We performed a total resection of the stomach on 145 patients: 63 were 60-69 years old, with a 14% mortality; 36 were 70-79 years old, with a 25% mortality. In curative gastrectomies, the mortality was 8% in patients in their seventies (4 cases out of 48) and 12% in their eighties (3 cases of 25). In additional resection of neighbouring organs (liver, colon, and pancreas) mortality was only increased to 17% in the seventh decade and 20% in the eighth. Therefore, radical surgery for carcinoma of the stomach in form of a gastrectomy is justified even in older people, as there is a curative chance. In palliative gastrectomies the mortality has been too high: 33% (5 out of 15) in the seventh decade and 58% (7 out of 12) over the seventh decade. Palliative gastrectomies are only justified in older people if there are special indications.

Adult↗