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result(s) for
"Anastomosis, Surgical - methods"
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Efficacy and safety of one anastomosis gastric bypass versus Roux-en-Y gastric bypass for obesity (YOMEGA): a multicentre, randomised, open-label, non-inferiority trial
by
Chouillard, Elie
,
Langlois-Jacques, Carole
,
Khamphommala, Lita
in
Adult
,
Anastomosis
,
Anastomosis, Roux-en-Y - adverse effects
2019
One anastomosis gastric bypass (OAGB) is increasingly used in the treatment of morbid obesity. However, the efficacy and safety outcomes of this procedure remain debated. We report the results of a randomised trial (YOMEGA) comparing the outcomes of OAGB versus standard Roux-en-Y gastric bypass (RYGB).
This prospective, multicentre, randomised non-inferiority trial, was held in nine obesity centres in France. Patients were eligible for inclusion if their body-mass index (BMI) was 40 kg/m2 or higher, or 35 kg/m2 or higher with the presence of at least one comorbidity (type 2 diabetes, high blood pressure, obstructive sleep apnoea, dyslipidaemia, or arthritis), and were aged 18–65 years. Key exclusion criteria were a history of oesophagitis, Barrett's oesophagus, severe gastro-oesophageal reflux disease resistant to proton-pump inhibitors, and previous bariatric surgery. Participants were randomly assigned (1:1) to OAGB or RYGB, stratified by centre with blocks of variable size; the study was open-label, with no masking required. RYGB consisted of a 150 cm alimentary limb and a 50 cm biliary limb and OAGB of a single gastrojejunal anastomosis with a 200 cm biliopancreatic limb. The primary endpoint was percentage excess BMI loss at 2 years. The primary endpoint was assessed in the per-protocol population and safety was assessed in all randomised participants. This study is registered with ClinicalTrials.gov, number NCT02139813, and is now completed.
From May 13, 2014, to March 2, 2016, of 261 patients screened for eligibility, 253 (97%) were randomly assigned to OAGB (n=129) or RYGB (n=124). Five patients did not undergo their assigned surgery, and after undergoing their surgery 14 were excluded from the per-protocol analysis (seven due to pregnancy, two deaths, one withdrawal, and four revisions from OAGB to RYGB) In the per-protocol population (n=117 OAGB, n=117 RYGB), mean age was 43·5 years (SD 10·8), mean BMI was 43·9 kg/m2 (SD 5·6), 176 (75%) of 234 participants were female, and 58 (27%) of 211 with available data had type 2 diabetes. After 2 years, mean percentage excess BMI loss was −87·9% (SD 23·6) in the OAGB group and −85·8% (SD 23·1) in the RYGB group, confirming non-inferiority of OAGB (mean difference −3·3%, 95% CI −9·1 to 2·6). 66 serious adverse events associated with surgery were reported (24 in the RYGB group vs 42 in the OAGB group; p=0·042), of which nine (21·4%) in the OAGB group were nutritional complications versus none in the RYGB group (p=0·0034).
OAGB is not inferior to RYGB regarding weight loss and metabolic improvement at 2 years. Higher incidences of diarrhoea, steatorrhoea, and nutritional adverse events were observed with a 200 cm biliopancreatic limb OAGB, suggesting a malabsorptive effect.
French Ministry of Health.
Journal Article
First-in-human robotic supermicrosurgery using a dedicated microsurgical robot for treating breast cancer-related lymphedema: a randomized pilot trial
2020
Advancements in reconstructive microsurgery have evolved into supermicrosurgery; connecting vessels with diameter between 0.3 and 0.8 mm for reconstruction of lymphatic flow and vascularized tissue transplantation. Supermicrosurgery is limited by the precision and dexterity of the surgeon’s hands. Robot assistance can help overcome these human limitations, thereby enabling a breakthrough in supermicrosurgery. We report the first-in-human study of robot-assisted supermicrosurgery using a dedicated microsurgical robotic platform. A prospective randomized pilot study is conducted comparing robot-assisted and manual supermicrosurgical lymphatico-venous anastomosis (LVA) in treating breast cancer-related lymphedema. We evaluate patient outcome at 1 and 3 months post surgery, duration of the surgery, and quality of the anastomosis. At 3 months, patient outcome improves. Furthermore, a steep decline in duration of time required to complete the anastomosis is observed in the robot-assisted group (33–16 min). Here, we report the feasibility of robot-assisted supermicrosurgical anastomosis in LVA, indicating promising results for the future of reconstructive supermicrosurgery.
Reconstructive microsurgery is limited by the precision that human hands can achieve. Here, the authors demonstrate in a randomized clinical pilot trial the feasibility of robot-assisted supermicrosurgery using a dedicated microsurgical robot for the completion of lymphatico-venous anastomosis in the treatment of breast cancer-related lymphedema
Journal Article
Effect of anti-reflux suture on gastroesophageal reflux symptoms after one anastomosis gastric bypass: a randomized controlled trial
by
Mousavimaleki, Ali
,
Shahsavan, Masoumeh
,
ShahabiShahmiri, Shahab
in
Clinical trials
,
Gastroesophageal reflux
,
Gastrointestinal surgery
2024
PurposeGastroesophageal reflux disease (GERD) is an issue after one anastomosis gastric bypass (OAGB) and modification of OAGB with adding an anti-reflux system may decrease the incidence of postoperative GERD. This study aimed to compare the efficacy of the anti-reflux mechanism to treat preoperative GERD and prevent de novo GERD.MethodsA prospective randomized clinical trial study was conducted on patients with a body mass index of 40 and more from August 2020 to February 2022. Patients undergoing one anastomosis gastric bypass with and without anti-reflux sutures (groups A and B, respectively). These patients had follow-ups for one year after the surgery. GERD symptoms were assessed in all the patients using the GERD symptom questionnaire.ResultsThe mean age was 39.5 ± 9.8 years and 40.7 ± 10.2 years in groups A and B respectively. GERD symptoms remission occurred in 76.5% and 68.4% of patients in groups A and B, respectively. The incidence of de novo GERD symptoms was lower in group A, compared to group B (6.2% and 16.1% in groups A and B respectively), without any statistically significant difference (p-value: 0.239).ConclusionGERD symptoms and de novo GERD after OAGB seems to be under-reported after OAGB. This study suggests that applying an anti-reflux suture can decrease de novo GERD symptoms.
Journal Article
A randomized controlled trial exploring the effect of placement versus nonplacement of a drainage tube around the cervical anastomosis in McKeown esophagectomy
2025
Esophageal cancer has an overall five-year survival rate of < 20%. The McKeown esophagectomy is invasive and carries a high risk of anastomotic leakage. Robust prospective outcome data comparing non-placement versus placement of a cervical drainage tube during McKeown esophagectomy are lacking. This study aimed to evaluate whether the placement of a cervical drainage tube is useful. In this randomized controlled, noninferiority trial, 106 patients with histologically proven, surgically resectable esophageal carcinoma were randomized to either placement or non-placement of a cervical drainage tube. The primary outcome was the percentage of Clavien-Dindo grade 2 or higher anastomotic leakage. Secondary outcomes included the duration from surgery to oral intake, hospital stay, and type and dose of analgesics used during hospitalization. Fifty-two and 54 patients were randomized to McKeown esophagectomy with non-placement and placement of a cervical drainage tube, respectively. There was no significant difference in anastomotic leakage rates between the non-placement (12/52 [23%]) and placement (13/54 [24%]) of drainage tube. However, non-inferiority was not demonstrated (risk difference, -0.100 [-0.17, 0.15]; p = 0.0591). There were no significant differences in the secondary outcome measures. Non-inferiority of nonplacement of a drainage tube around the cervical anastomosis after McKeown esophagectomy to placement of that was not demonstrated. Further large multicenter studies are needed.Trial registration: Japan Registry of Clinical Trials (identification number jRCT1052180016).
Journal Article
Bowel function after laparoscopic right hemicolectomy: a randomized controlled trial comparing intracorporeal anastomosis and extracorporeal anastomosis
2022
BackgroundThe laparoscopic right hemicolectomy is the standard surgical treatment for right-sided colon cancer. The continuity of the digestive tract is restored through ileocolic anastomosis which can be performed extracorporeally or intracorporeally. The study aimed to compare both anastomotic techniques in laparoscopic right hemicolectomy.Materials and methodsA single-blinded two-armed randomized control trial with 1:1 parallel allocation carried out from 2016 to 2020 in a single center. The follow-up period was 30 days. Compared interventions involved extracorporeal and intracorporeal ileocolic anastomosis in laparoscopic right hemicolectomy. The main outcome of the study was bowel recovery measured as the time to the first stool. Other outcomes involved the time to the first flatus, morbidity, and duration of surgery.ResultsOne hundred and seventeen patients undergoing a laparoscopic right hemicolectomy with curative intent were eligible for the trial. Eight patients refused to participate. One hundred and two patients were analyzed, 52 in the intracorporeal group and 50 in the extracorporeal group. The groups did not differ in terms of cancer stage or body mass index, but did differ in age and sex. Intracorporeal anastomosis was associated with a shorter time to the first stool than extracorporeal, 32.8 h (26.0–43.7) vs. 41.7 (35.9–50.0), p = 0.017. There was no significant difference in the time to the first flatus, 30 h (23.2–42.3) vs. 26.6 h (21.8–37.3), p = 0.165. Similarly, overall complications did not differ (EC 12/50 vs. IC 10/52, p = 0.56). There were no differences in length of surgery, 190 min (150–230) and 190 min (180–220), p = 0.55.ConclusionIntracorporeal ileocolic anastomosis following laparoscopic right hemicolectomy results in slightly faster bowel recovery, with no differences in morbidity and duration of surgery.
Journal Article
Long-term prognosis of intracorporeal versus extracorporeal anastomosis in stage II/III colorectal cancer (INEX study): study protocol for a multicenter randomized controlled trial in Japan
by
Hanaoka, Marie
,
Tokunaga, Masanori
,
Ishiguro, Megumi
in
Abdomen
,
Anastomosis
,
Anastomosis, Surgical - methods
2025
Background
Intracorporeal anastomosis (IA) for colon cancer has garnered attention owing to its minimally invasive nature and compatibility with advanced robot-assisted surgery. IA offers advantages such as smaller incisions, reduced postoperative pain, and quicker recovery. However, concerns persist in basic research regarding the increased risk of tumor cell dissemination due to IA, which may lead to peritoneal recurrence as a result of exposure of the intestinal lumen under high intra-abdominal pressure. Evidence regarding the long-term oncological outcomes of IA is limited, with no randomized controlled trials (RCTs) addressing this issue. Furthermore, no ongoing RCTs focus on long-term outcomes as a primary endpoint regarding two anastomosis techniques, and clinical guidelines do not currently recommend a preferred anastomotic method. This multicenter RCT aims to assess the non-inferiority of IA compared with EA in the surgery of colon cancer.
Methods
This multicenter, open-label RCT will enroll 1,400 patients with clinical stage II or III colon cancer undergoing laparoscopic or robot-assisted colectomy across 47 institutions in Japan. Eligible patients must have tumors located in the cecum, ascending, transverse, or descending colon. Participants will be randomized to receive either EA or IA. Each participating institution must have a board-certified endoscopic surgeon to ensure surgical quality. Colon resection will include D2 or D3 lymph node dissection, in accordance with the Japanese Classification of Colorectal Carcinoma. The primary endpoint is relapse-free survival, with long-term follow-up planned.
Discussion
This trial will be the first RCT to evaluate long-term oncological outcomes as the primary endpoint when comparing IA and EA during minimally invasive colon cancer surgery. If IA is non-inferior to EA in relapse-free survival, the choice of anastomotic technique can be tailored to the expertise of individual institutions and surgeons. Conversely, if IA fails to demonstrate non-inferiority, EA will remain the standard treatment. Given the current lack of long-term outcome data comparing IA and EA in colon cancer, this study will provide valuable insights that may influence future surgical standards and guideline recommendations.
Trial registration
jRCT1032240435.
Journal Article
Optimizing pediatric loop colostomy closure: a comparative study of linear stapler and hand-sewn anastomosis
by
Nabi, Ubayer
,
Nisar, Sabina
,
Shah, Waseem Jan
in
Age groups
,
Anastomosis
,
Anastomosis, Surgical - adverse effects
2025
Background
Conventional hand suture techniques for intestinal anastomosis have been standard practice for decades, but the development of staplers has significantly impacted surgical procedures. Staplers, designed to simplify surgery, have been increasingly used in various gastrointestinal surgeries, including pediatric procedures. Colostomy takedown in infants is a commonly performed surgical procedure in pediatric surgery, yet the optimal technique remains debated. This study aims to compare the outcomes of linear stapler anastomosis and hand-sewn anastomosis for elective closure of loop colostomies in children. The hypothesis is that linear stapler anastomosis offers advantages over hand-sewn anastomosis in terms of operative time, recovery, and hospital stay.
Aim
To compare the outcomes of linear stapler and hand-sewn anastomosis in the elective closure of pediatric loop colostomies.
Methods
This prospective, randomized controlled study was conducted at Sher-i-Kashmir Institute of Medical Sciences (SKIMS), Soura, J&K, India, between 2021 and 2023. A total of 70 infants were enrolled, randomly assigned to two groups: Group A (35 infants) underwent SA (Stapled Anastomosis), and Group B (35 infants) underwent HS (Hand-Sewn Anastomosis). Both groups were matched for clinical characteristics. The primary outcomes included operative time and time to return of bowel movements. Secondary outcomes included anastomotic leaks, wound infections, and length of hospital stay. Data analysis was performed using appropriate statistical methods including t-tests and chi-square tests.
Results
The mean age of patients was 5.79 ± 3.23 months in Group A and 4.21 ± 3.13 months in Group B. The mean time to return of bowel movements was significantly shorter in Group A (24.82 ± 6.34 h) compared to Group B (47.56 ± 5.65 h, p = 0.05). Oral feeding was commenced earlier in Group A (2.18 ± 0.39 days) than in Group B (3.16 ± 0.37 days, p < 0.001). Both groups had a follow-up of 1.81 ± 0.98 years, with no cases of anastomotic leakage or small bowel obstruction in either group. Hospital stay was shorter in Group A (53.82 ± 6.34 h) compared to Group B (79.56 ± 15.65 h, p < 0.0003).
Journal Article
COLOR IV: a multicenter randomized clinical trial comparing intracorporeal and extracorporeal ileocolic anastomosis after laparoscopic right colectomy for colon cancer
by
Bonjer, Hendrik
,
Wu, Si
,
Gao, Jiale
in
Abdominal Surgery
,
Anastomosis, Surgical - adverse effects
,
Anastomosis, Surgical - methods
2025
Introduction
Right-sided colon cancer is a prevalent malignancy. The standard surgical treatment for this condition is laparoscopic right hemicolectomy, with ileocolic anastomosis being a crucial step in the procedure. Recently, intracorporeal ileocolic anastomosis has garnered attention for its minimally invasive benefits. However, there remains a paucity of rigorously designed, large-scale, international multicenter randomized controlled trials to definitively assess the safety and efficacy of intracorporeal ileocolic anastomosis in laparoscopic right hemicolectomy for right-sided colon cancer.
Methods
This study is an international, multicenter, randomized, controlled, open-label, non-inferiority trial designed to compare the safety and efficacy of intracorporeal versus extracorporeal ileocolic anastomosis in patients with right-sided colon cancer undergoing right hemicolectomy. The primary endpoint is the anastomotic leakage rate within 30 days post-surgery. The main secondary endpoint is the 3-year disease-free survival rate post-surgery. A comprehensive quality assurance protocol will be established before the trial begins, including CT review, pathological evaluation, and the standardization and assessment of surgical techniques.
Discussion
This study aims to evaluate the safety and efficacy of intracorporeal ileocolic anastomosis following right hemicolectomy in patients with right-sided colon cancer. The anticipated outcome is that intracorporeal ileocolic anastomosis will show an anastomotic leakage rate and a 3-year disease-free survival rate comparable to those of extracorporeal anastomosis, while offering the added benefit of faster postoperative recovery.
Graphical abstract
Journal Article
Comparison of clinical efficacy between modified Kamikawa anastomosis in laparoscopic proximal gastrectomy and Roux-en-Y anastomosis in laparoscopic total gastrectomy
2024
To investigate the short-term clinical efficacy of laparoscopic proximal gastrectomy with modified Kamikawa anastomosis and laparoscopic total gastrectomy with Roux-en-Y anastomosis. Retrospective cohort study was conducted. The clinicopathological data of 268 patients who underwent laparoscopic proximal gastrectomy for adenocarcinoma of esophagogastric junction and upper gastric adenocarcinoma from January 2016 to October 2022 were collected. Among 268 patients, 26 underwent laparoscopic proximal gastrectomy with modified Kamikawa anastomosis were assigned to Kamikawa group and 242 underwent laparoscopic total gastrectomy with Roux-en-Y anastomosis were assigned to Roux-en-Y group. The sex, age, BMI, preoperative albumin, maximum tumor diameter, histological grade, and pathological stage of patients in the Kamikawa group and the Roux-en-Y group were subjected to 1:1 propensity score matching. After matching, 16 patients in Kamikawa group and Roux-en-Y group were respectively included in this study. Outcome measures: (1) Intraoperative condition. (2) Postoperative recovery. (3) Follow-up information. The patients' nutritional status, reflux esophagitis and anastomotic stoma were investigated by outpatient and telephone follow-up. Nutritional status assessment comprising body mass index and Nutritional Risk Screening 2002 score. (1) Intraoperative condition. All patients successfully underwent laparoscopic proximal gastrectomy and total gastrectomy. Compared with Roux-en-Y group, the digestive tract reconstruction time in Kamikawa group was longer 93.0(74.0–111.0)min vs. 39.7(35.1–46.2)min, t = -2.001,
P
= 0.055., and the difference was statistically significant (
P
< 0.05). There was no statistically significant difference in total operation time and intraoperative blood loss (
P
> 0.05). (2) Postoperative recovery. There was no statistically significant difference between Kamikawa group and Roux-en-Y group in first anal exhaust time, first postoperative liquid intake time, postoperative hospitalization time, and postoperative complications (
P
> 0.05). (3) Follow-up information. All patients were followed up. BMI and NRS 2002 scores in Kamikawa group were better than those in Roux-en-Y group at 6 and 12 months after surgery 22.9 ± 3.0 kg/m2 vs. 20.8 ± 2.2 kg/m2, t = 2.165,
P
= 0.038; 23.1 ± 3.0 kg/m2 vs. 20.3 ± 2.2 kg/m2, t = 3.022,
P
= 0.005 and 2 (1–2) vs. 2 (1–3), Z = -2.585,
P
= 0.010; 2 (1–2) vs. 2 (1–3), Z = -2.273,
P
= 0.023., the difference was statistically significant (
P
< 0.05). There was no significant difference in GERD scale score and occurrence of ≥ Grade B reflux esophagitis at 6 and 12 months after surgery between Kamikawa group and Roux-en-Y group (
P
> 0.05). Anastomotic stenosis was not found in all patients by postoperative upper gastrointestinal angiography. Laparoscopic proximal gastrectomy with modified Kamikawa anastomosis is safe and feasible for the treatment of esophagogastric junction and upper gastric adenocarcinoma, and can achieve good anti-reflux effect. Besides, compared with traditional laparoscopic total gastrectomy, its postoperative nutritional status is better.
Journal Article
A comparative study of single versus double venous anastomosis with microvascular anastomotic coupler device (MACD) in maxillofacial reconstructions with free flaps
2025
Recently, venous couplers have been routinely employed for free flap surgery. Its use is justified considering the large number of backlog cases as well as for surgeon and patient benefit. However, venous thrombosis remains a worrisome problem in the use of venous couplers. Although the efficacy of venous couplers has been found to be equal to that of hand-sewn anastomosis, comparison of single versus double venous coupler anastomosis has not been reported. A prospective randomized study carried between 2020 and 2024 included 154 patients who underwent maxillofacial free flap reconstruction; these patients were divided into two groups based on the number of venous coupler anastomoses performed. (Single MACD, n = 82 vs. Double MACD, n = 72). Data were evaluated for demographics, perioperative details, vascular thrombosis, flap complications and flap loss. There were no significant differences regarding comorbidities or ASA status between the two groups. Overall, there was no significant difference regarding the rate of venous thrombosis (1 MACD: 2.44% versus 2 MACD: 2.78%, p > 0.05) or flap loss (1 MACD: 1.22% versus 2 MACD: 1.39%, p > 0.05). As our overall survivability rate was more than 97% in each group, it can be concluded that flap survivability is not dependent on the number of venous coupler anastomoses and that it would be safe to proceed with single venous coupler anastomosis with close flap monitoring. Various other factors, such as improper technique, intimal injury, hematoma and pedicle compression, may play more prominent roles in flap survivability.
Journal Article