Endoscopic management of acute sigmoid volvulus in high risk surgical elderly patients: a randomized controlled trial.

BACKGROUND: Most patients with sigmoid volvulus are of old age with multiple comorbidities. So, the risk of surgery for those elderly patients is usually associated with increased rates of morbidity and mortality. Early intervention is required for managing sigmoid volvulus to avoid its serious complications; therefore, early endoscopic untwist of sigmoid colon can be performed followed by endoscopic fixation of sigmoid colon under sedation in this category of the patients to avoid development of high risk surgical complications following surgical fixation of sigmoid colon or sigmoidectomy after initial simple loop colostomy procedure to relieve obstruction. METHODS: This prospective randomized controlled clinical trial included all patients who developed acute sigmoid volvulus and were referred to the Zagazig University Hospital Emergency Department between December 2020 and August 2022. The study was prospectively approved by Zagazig University Faculty of Medicine Institutional Review Board (Approval Number: 9989/23-10-2022) and was retrospectively submitted in http://clinicaltrials.gov in November 2022 ( http://clinicaltrials.gov ID: NCT05620446). Included eligible patients were simply randomized at a 1:1 ratio to "Endoscopic Group (EG)" or "Surgical Group (SG)" via drawing of sealed envelopes containing computer-generated random numbers prepared by a third party before start of intervention. RESULTS: Sample size included 18 patients divided into 2 equal groups. (1) Endoscopic group included 9 patients who were subjected to endoscopic untwist of sigmoid colon followed by endoscopic fixation of sigmoid colon under sedation; (2) Surgical group included 9 patients who were subjected to surgical fixation of sigmoid colon or sigmoidectomy after initial simple loop colostomy under general anesthesia. In comparison between both groups, there were statistically significant differences regarding length of hospital stay and procedure time. Unfortunately, there were no statistically significant differences regarding postoperative complications and co-morbidities. Eight patients in the endoscopy group demonstrated excellent quality of life, and one demonstrated good quality of life; unlike the surgical group, there were 3 patients with excellent quality of life, 5 patients with good quality of life, and 1 patient with poor quality of life. So there was statistically significant difference regarding quality of life between both groups. During the 9-month follow-up period, both groups demonstrated no cases of recurrence post-fixation. CONCLUSION: Endoscopic management of acute sigmoid volvulus is effective and safe in elderly high risk surgical patients (either in managing the intestinal obstruction caused by volvulus or in definitive treatment of volvulus).

Endoscopic management of low output recurrent colonic fistula or leak after anterior resection for rectal cancer: a randomized controlled trial.

BACKGROUND: Colonic anastomotic leak and fistula following anterior resection surgery for rectal cancer are associated with high mortality rates. The incidence of occurrence varies from 2 to 25% and it is difficult to accurately calculate the incidence of fistula and leak post anterior resection, as most of them are asymptomatic. Endoscopic management of fistula and leak has become the first line of management after conservative management in many gastrointestinal surgical centers with the advantages of being less invasive, shorter length of post-operative hospital stay, effective and rapid recovery in comparison to revision surgery. Effective endoscopic management for colonic fistula or leak depends on the clinical status of the patient and fistula characters (time-to-occur and size and site of defect), and device availability. METHODS: This prospective randomized controlled clinical trial included all patients who developed the manifestations of low output recurrent colonic fistula or leak after colonic anterior resection for rectal cancer at Zagazig University Hospital between (December 2020 and August 2022). Sample size was 78 patients divided into two equal groups. Endoscopic group (EG): included 39 patients who underwent endoscopic management. Surgical group (SG): included 39 patients who underwent surgical management. RESULTS: The investigators randomized eligible 78 patients into two groups: 39 patients in SG and 39 patients in EG. The median size of the fistula or leak was nine (range: 7-14) mm in EG, versus ten (range: 7-12) mm in SG. Clipping and Endo-stitch device were used in 24 patients versus 15 patients, respectively, in EG while primary repair with ileostomy, and resection & anastomosis were used in 15 patients versus 24 patients, respectively, in SG. Recurrence, abdominal collection, and mortality were the post procedure's complications with incidence of occurrence of 10.3, 7.7 and 0%, respectively, in EG versus 20.5, 20.5 and 2.6%, respectively, in SG. Excellent, good, and poor were the parameters for quality of life with incidence of occurrence of 43.6, 54.6 and 0%, respectively, in EG versus 28.2, 33.3 and 38.5%, respectively, in SG. Median hospital stay was one (range: 1-2) day in endoscopic group, and seven (range: 6-8) days in SG. CONCLUSION: Endoscopic intervention may offer a successful modality in managing low output recurrent colonic fistula or leak after anterior resection for rectal cancer that did not respond to conservative measures in stable patients. CLINICALTRIALS: gov ID: NCT05659446.

Endoscopic management of refractory leak and gastro-cutaneous fistula after laparoscopic sleeve gastrectomy: a randomized controlled trial.

BACKGROUND: Gastro-cutaneous fistula is a rare complication after laparoscopic sleeve gastrectomy (LSG) with incidence of occurrence 1-2%. Most of gastro-cutaneous fistulae do not respond to conservative management and need intervention either surgically or endoscopically. METHODS: This prospective randomized clinical study included referred patients who had LSG performed at our department or other centers, and complicated with post-LSG leak or gastro-cutaneous fistula between December/2019 and March/2021. Included patients were ASA Physical status I-II. Primary and secondary outcomes were recurrence of the fistula and mortality in each group after the intervention during the 18 months follow-up period, respectively. RESULTS: Thirty patients were randomized into two groups: Surgery Group (SG, n = 15) and Endoscopy Group (EG, n = 15). Mean age of patients was 42.3 ± 8.7 and 42.6 ± 8.3 years-old in SG and EG, respectively. Females constituted 73.3% and 80% in SG and EG, respectively. Median time-to-gastric leak post LSG was six (range: 4-7) days in both groups. SG patients were surgically managed with primary repair of the gastric fistula and gastrojejunostomy in 13 patients or converting SG into Roux-en-Y gastric bypass in two patients, while EG patients were endoscopically managed with stitching, stenting, stenting and dilation, and clipping and dilation in 5, 4, 4 and 2 patients, respectively. Incidence of recurrent leak during 1st week was significantly higher in SG than EG (p < 0.001). No mortality reported in EG, while 2 patients died in SG (p = 0.48). CONCLUSION: Endoscopic intervention may offer a successful modality in managing post-LSG gastric leak and gastro-cutaneous fistula that do not respond to conservative measures in stable patients.

Combined endoscopic and radiologic intervention for management of acute perforated peptic ulcer: a randomized controlled trial.

BACKGROUND: Peptic ulcer perforation is a common life-threatening surgical emergency. Graham omental patch is performed for plugging of perforated peptic ulcer. Many endoscopic methods have been used to treat acute perforated peptic ulcer such as over the scope clips, standard endoscopic clips, endoscopic sewing and metallic stents. The main idea in endoscopic management of acute perforated peptic ulcer is early decontamination and decrease sepsis by interventional radiologic drainage. METHODS: This is a prospective randomized controlled clinical trial. This study included patients who were developed acute perforated peptic ulcer manifestations and were admitted to our hospital between December 2019 and August 2021. Sample size was 100 patients divided into 2 equal groups. Endoscopic group (EG): included 50 patients who were subjected to endoscopic management. Surgical group (SG): included 50 patients who were subjected to surgical management. RESULTS: One hundred patients were randomized into 2 groups: SG (50) and EG (50). Median age of patients was 36 (range 27:54) and 47 (range 41:50) years-old in SG and EG, respectively. Males constituted 72% and 66% in SG and EG, respectively. Median length of postoperative hospital stay was 1 (range: 1-2) days in EG, while in SG was 7 (range 6-8) days. Postoperative complications in SG patients were 58% in form of fever, pneumonia, leak, abdominal abscess, renal failure and incisional hernia (11%, 5%, 5%, 3%, 2% and 3%, respectively). Postoperative complications in EG patients were 24% in form of fever, pneumonia, leak, abdominal abscess, renal failure and incisional hernia (10%, 0%, 2%, 0%, 0% and 0%, respectively). CONCLUSION: Combined endoscopic and interventional radiological drainage can effectively manage acute perforated peptic ulcer without the need for general anesthesia, with short operative time, in high risk surgical patients with low incidence of morbidity & mortality.

The short-term outcome of distal mesogastric fixation after laparoscopic sleeve gastrectomy: a randomized controlled trial.

PURPOSE: The proposed etiology of leakage after laparoscopic sleeve gastrectomy may be the axial rotation of the stomach owing to the loss of abdominal ligament fixation along the greater curvature of the stomach. The mechanism of increased intra-gastric pressure due to axial gastric rotation may place a great deal of stress on the staple lines, leading to an increased incidence of leakage. Other complications may occur, including vomiting, food intolerance or persistent reflux. METHODS: This study was registered in ClinicalTrials.gov (ID: NCT04834323). This study included patients who were admitted to our center to undergo laparoscopic sleeve gastrectomy. Cases were collected in the period from December 2019 to December 2020. The study population included 83 patients, who were divided into the following two groups: Group 1 included 42 patients who received distal mesogastric fixation after laparoscopic sleeve gastrectomy; Group 2 included 41 patients who received laparoscopic sleeve gastrectomy alone without distal mesogastric fixation. RESULTS: No leakage or axial rotation occurs after laparoscopic sleeve gastrectomy with distal fixation, while in patients without distal fixation, leakage and axial rotation occurred with no statistically significant differences between the two groups. Leakage and axial rotation occurred two times more frequently among patients who received laparoscopic sleeve gastrectomy without distal fixations. CONCLUSION: Distal mesogastric fixation after laparoscopic sleeve gastrectomy decreased the axial gastric rotation and subsequently decreased gastric leakage.

Recurrent appendicitis following successful drainage of appendicular abscess in adult without interval appendectomy during COVID-19. Prospective cohort study.

BACKGROUND: COVID-19 infection is a global pandemic that affected routine health services and made patients fear to consult for medical health problems, even acute abdominal pain. Subsequently, the incidence of complicated appendicitis increased during the Covid-19 pandemic. This study aimed to evaluate recurrent appendicitis after successful drainage of appendicular abscess during COVID-19. MATERIAL AND METHODS: A prospective cohort study conducted in the surgical emergency units of our Universities' Hospitals between March 15, 2020 to August 15, 2020 including patients who were admitted with the diagnosis of an appendicular abscess and who underwent open or radiological drainage. Main outcomes included incidence, severity, and risk factors of recurrent appendicitis in patients without interval appendectomy. RESULTS: A total of 316 patients were included for analysis. The mean age of the patients was 37 years (SD ± 13). About two-thirds of patients were males (60.1%). More than one-third (39.6%) had co-morbidities; type 2 diabetes mellitus (T2DM) (22.5%) and hypertension (17.1%) were the most frequent. Approximately one quarter (25.6%) had confirmed COVID 19 infection. About one-third of the patients (30.4%) had recurrent appendicitis. More than half of them (56.3%) showed recurrence after three months, and 43.8% of patients showed recurrence in the first three months. The most frequent grade was grade I (63.5%). Most patients (77.1%) underwent open surgery. Age, T2DM, hypertension, COVID-19 infection and abscess size >3 cm were significantly risking predictors for recurrent appendicitis. CONCLUSIONS: Interval appendectomy is suggested to prevent 56.3% of recurrent appendicitis that occurs after 3 months. We recommend performing interval appendectomy in older age, people with diabetes, COVID-19 infected, and abscesses more than 3 cm in diameter. RESEARCH QUESTION: Is interval appendectomy preventing a high incidence of recurrent appendicitis after successful drainage of appendicular abscess during COVID-19 pandemic?