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1.
Palliative Medicine in Practice ; 16(4):199-202, 2022.
Article in English | EMBASE | ID: covidwho-2324399
2.
European Urology ; 83(Supplement 1):S1167, 2023.
Article in English | EMBASE | ID: covidwho-2299480

ABSTRACT

Introduction & Objectives: The frequency of involvement in the oncological process of the ureters in case of pelvis tumors ranges from 15 to 20%. The use of the appendix as a plastic material for the reconstruction of extended ureteral defects (EUD), including left-sided ones, remains debatable. The main goal of this study is evaluating the clinical and functional results after EUD repair using patchy transposition of the appendix. Material(s) and Method(s): Since August 2019 to June 2021, 8 laparoscopic surgeries were performed to replace the EUD using flap transposition of the appendix. Of these, 6 on the left (75%), 2 on the right (25%). 7 women (87.5%) and 1 man (12.5%) were operated on. Mean age 53+/-10.6 years. Average BMI 25.9 kg/m2. Etiology EUD: 25% radiotherapy (n2), 50% iatrogenic surgery (n4), 12.5% (n1) primary ureteral cancer, 12.5% (n1) non-Hodgkin's lymphoma. In all cases, the first stage was a wide mobilization of the ileocecal angle, the appendix was disconnected with a 45 mm hardware suture, in case of left-sided lesion, the appendix was moved isoperistaltically under the mesentery of the sigmoid colon to the left side after preliminary maximum mobilization of the process on the vascular pedicle in the form of a "triangle". All patients received a 7Fr ureteral stent. CT urography was performed on the 3rd, 7th, 11th days. Dynamic nephroscintigraphy was performed on the 90th day. Result(s): The average length of diastasis is 4.6+/-1.7 cm. The average length of the mobilized appendix was 8+/-1.8 cm. Replacement of the ureter with an appendix and a flap of the bladder according to the Demel method was performed in 1 case (12.5%), according to the Boari method in 1 case (12.5%), in 6 (75%) cases an anastomosis was formed according to the "end-to-end" type. the end". The average duration of the operation was 251+/-40.9 min, blood loss was 121+/-56.7 ml. Median removal of the ureteral stent was 36+/-18.28 days. Duration of hospital stay was 14+/-5.2 days. Median follow-up 10+/-5.3 months. Early complications (<30 days): 2 cases of urinary edema (Clavien-Dindo II), 2 cases of ipsilateral hydronephrosis (Clavien-Dindo I-II). Late complications (>30 days): 1 case of partial failure of ureterocystoanastomosis against the background of Sars-Cov-2 infection (Clavien-Dindo IIIa), 1 case of non-functioning left kidney (Clavien-Dindo IVa). Dynamic nephroscintigraphy was performed in 68.4% of patients, the average isotope accumulation time was 4.23+/-0.25 minutes, the duration of the half-life was 14.26+/-0.52 minutes. Conclusion(s): Flap transposition with the appendix is a technically difficult but possible option for extended ureteral strictures. However, various pathological processes that have developed against the background of previous treatment potentially increase the risk of developing repeated strictures or anastomotic leaks. Therefore, given the small sample of patients, further research on this issue is required.Copyright © 2023.

3.
Surgery Open Science ; 11:26-32, 2023.
Article in English | EMBASE | ID: covidwho-2281514

ABSTRACT

Background: Anastomotic leak (AL) after minimally invasive esophagectomy (MIE) is a well-described source of morbidity for patients undergoing surgical treatment of esophageal neoplasm. With improved early recognition and endoscopic management techniques, the long-term impact remains unclear. Method(s): A retrospective review was conducted of patients who underwent MIE for esophageal neoplasm between January 2015 and June 2021 at a single institution. Cohorts were stratified by development of AL and subsequent management. Baseline demographics, perioperative data, and post-operative outcomes were examined. Result(s): During this period, 172 MIEs were performed, with 35 of 172 (20.3%) complicated by an AL. Perioperative factors independently associated with AL were post-operative blood transfusion (leak rate 52.9% versus 16.8%;p = 0.0017), incompleteness of anastomotic rings (75.0% vs 19.1%;p = 0.027), and receiving neoadjuvant therapy (18.5% vs 30.8%;p < 0.0001). Inferior short-term outcomes associated with AL included number of esophageal dilations in the first post-operative year (1.40 vs 0.46, p = 0.0397), discharge disposition to a location other than home (22.9% vs 8.8%, p = 0.012), length of hospital stay (17.7 days vs 9.6 days;p = 0.002), and time until jejunostomy tube removal (134 days vs 79 days;p = 0.0023). There was no significant difference in overall survival between patients with or without an AL at 1 year (79% vs 83%) or 5 years (50% vs 47%) (overall log rank p = 0.758). Conclusion(s): In this large single-center series of MIEs, AL was associated with inferior short-term outcomes including hospital length of stay, discharge disposition other than to home, and need for additional endoscopic procedures, without an accompanying impact on 1-year or 5-year survival. Key message: In this large, single-center series of minimally invasive esophagectomies, anastomotic leak was associated with worse short-term outcomes including hospital length of stay, discharge disposition other than to home, and need for additional endoscopic procedures, but was not associated with worse long-term survival. The significant association between neoadjuvant therapy and decreased leak rates is difficult to interpret, given the potential for confounding factors, thus careful attention to modifiable pre- and peri-operative patient factors associated with anastomotic leak is warranted.Copyright © 2022 The Authors

4.
Turkish Journal of Pediatric Disease ; 16(2):165-167, 2022.
Article in English | EMBASE | ID: covidwho-2235849

ABSTRACT

Aim is to discuss diagnostic and therapeutic difficulties in COVID-19 related postoperative outcomes. A 5-year-old boy operated for jejunal atresia in neonatal period admitted with recurrent bilious vomiting. The upper GI series revealed dilated jejunum and absence of mechanical obstruction. The dilated jejunal segment was excised and anastomosis was performed. Later, he developed peritonitis without signs of anastomotic leaks. The second surgical exploration revealed diffuse peritonitis causing thickened and fibrous bowel loops causing hardly lysable adhesions. Then, his grandmother was learned to be COVID-PCR positive. Therefore, patients with atypical postoperative course should be investigated for possible COVID-19 during pandemics. Copyright © 2022 Ankara Pediatric Hematology Oncology Training and Research Hospital. All rights reserved.

5.
Colorectal Disease ; 23(Supplement 2):154, 2021.
Article in English | EMBASE | ID: covidwho-2192487

ABSTRACT

Aim: The SARS-Cov- 2 pandemic has been undoubtedly overwhelming for elective colorectal cancer resections. However, early establishment of a green pathway has enabled our trust to operate in a clean, covid-19 free environment and this project aims to demonstrate this pathway. Method(s): Elective colorectal cancer resections have been included in this cohort from January until July 2020. Emergency and benign resections have been excluded from this study. The main procedures that have been performed were laparoscopic right hemicolectomies and high anterior resections. Complication rate was classified using the Clavien-Dindo scale. Patients from March 2020 onwards were operated and nursed post-operatively on a green covid-19 pathway. Result(s): A total of 62 patients were included in this study. Resections were mainly performed laparoscopically (85%) and these were mainly right hemicolectomies (41%) and high anterior resections (31%). There has been a single Covid19 positive resection and that was before the pathway has been established. The median length of stay was 5 days for all resections. The main post-operative complication was ileus and there were no anastomotic leaks. Conclusion(s): Elective colorectal resections during a respiratory pandemic are safe and feasible with appropriately established pathways.

6.
Colorectal Disease ; 23(Supplement 2):53, 2021.
Article in English | EMBASE | ID: covidwho-2192469

ABSTRACT

Aim: The COVID-19 pandemic has presented many challenges to colorectal cancer (CRC) care. Many organisations opted to perform CRC resections in "cold" sites. Infrastructure in Northumbria Healthcare NHS Foundation Trust (NHCT) necessitated co-locating CRC care with "hot" COVID streams but with additional precautions. This study aimed to evaluate that approach for a consecutive series of CRC cases, diagnosed before and during the COVID-19 pandemic. Method(s): A prospectively populated dataset of CRC patients diagnosed between 01/04/2019 and 30/09/2020 was used. Patients presenting before 01/04/2020 were considered "Pre-COVID" and those subsequently "COVID era". Result(s): Three hundred and forty-four cases were diagnosed in the 12 months "Pre-COVID" and 166 in the 6 months of the "COVID era". The median days from referral to diagnosis (21 vs 20, P = 0.373) and operation (63 vs 61, P = 0.208) were unchanged. The "COVID era" saw an increase in the proportion of radiological diagnoses (39.5% vs 53.0% P = 0.004) with an associated decrease in endoscopic diagnoses (56.7% vs 45.8%, P = 0.021). Rates of inoperable (1.5% vs 1.2%, P = 0.821), obstructing (11.0% vs 16.2%, P = 0.272) and perforated tumours (0.6% vs 1.5%, P = 0.492) remained the same. One patient developed COVID-19 peri-operatively. Rates of laparoscopic operation (59.5% vs 61.8%, P = 0.751), anastomotic leak (6.4% vs 5.9%, P = 0.891), re-operative surgery (10.4% vs 4.4%, P = 0.138), primary stoma (40.5% vs 32.4%, P = 0.244) and 90-day mortality (0.6% vs 1.5%, P = 0.492) did not change. Conclusion(s): With appropriate infection control measures, it may be safe to continue providing standard elective and urgent CRC care without access to a "COVID clean" site.

7.
British Journal of Surgery ; 109(Supplement 9):ix65, 2022.
Article in English | EMBASE | ID: covidwho-2188338

ABSTRACT

Background: With many resources redirected to care for the those affected by the COVID-19 pandemic, the NHS faced unprecedented pressure to maintain oesophagogastric (OG) cancer resectional services. Our institution along with many tertiary units across the country were faced with limited access to essential critical care beds. The implementation of emergency contracts between the NHS and the independent sector (IS) allowed our unit to maintain a high volume resectional service by utilising the resources of a local private hospital with HDU/ ITU provision. We began operating within the IS shortly after the first UK lockdown in March 2020, and continued through till February 2022. During this period, we continued operating at our tertiary unit (TU) albeit at a reduced capacity. This study aimed to evaluate the surgical outcomes of patients undergoing major OG resectional surgery between the two sites. Method(s): This retrospective study included all patients who underwent major OG resectional surgery (including GIST) from March 2020-February 2022. Operation type and site were identified using OPCS-4 clinical codes and combined with National OG Cancer Audit (NOGCA) data to compare basic patient demographics, length of stay, complication rates, COVID infection rates and 90-day mortality. Descriptive and statistical analysis between the two operating sites was performed. Result(s): A total of 204 major OG resections were undertaken, 44% (89) at our TU;57 oesophagectomies and 32 gastrectomies, with 56% (115) at a local IS hospital;86 oesophagectomies and 29 gastrectomies. Additionally, 13 (6.4%) open and close procedures were performed across both sites. Median patient age was similar, 69 (45-86) years at our TU v. 68 (38-85) years at the IS site. A higher proportion of ASA 3 patients (46%) were operated on at our TU. No difference in median length of stay was observed;TU= 8 (1-93) days v. IS =9 (3-69) days, this included all patients who were repatriated to the TU. Higher complication rates seemed to occur in patients operated at the IS site v. the TU though these did not reach statistical significance;18 (15.7%) patients suffered an anastomotic leak v. 9 (10.1%) respectively (p= 0.246). 21 (18.3%) v. 13 (14.6%) patients suffered a major respiratory (p=0.487) and 4 (3.5%) v. 1 (1.1%) a major cardiac (p=0.281) complication. There were no cases of COVID infection within 30 days of primary procedure at the IS site, with 2 cases within the TU cohort. Our 90-day mortality rates were similar (IS= 4.54% v. TU=5.32%), p=0.661. Conclusion(s): Our study demonstrates that resection of patients with OG cancer is feasible in an independent sector hospital if supported by critical care. It allowed a high-volume tertiary unit to continue offering potentially curative surgery to patients whose treatment options would have otherwise been limited to oncological therapy only. Long term survival data compared to non-resecting trusts is required to determine whether this approach was superior. When considering future pandemic planning, we have demonstrated the value of this model in maintaining major OG resectional services.

8.
British Journal of Surgery ; 109(Supplement 5):v140, 2022.
Article in English | EMBASE | ID: covidwho-2134896

ABSTRACT

Aim: To determine The efficacy of single layer bowel repair with respect to postoperative complications such as leakage rates, duration of repair, overall length of hospital stay, cost effectiveness, to assess The morbidity, mortality and outcome. Method(s): This prospective study was done on 21 patients admitted under Department of Surgery from The period of January 2020 to September 2021. All The patients under bowel repair in continuous single layer extramucosal fashion for various etiology, follow up data was collected and analysed. Result(s): In our study, 81% (17 cases) of The single layer bowel repair were done in an Emergency setting. The study consisted of 42.9% (9 cases) of perforation repair and 57.1% (12 cases of resection and anastomosis of large or small bowel). The average time duration of anastomosis was 14.45 minutes with The average hospital stay of 13.2 days. Our study showed an anastomotic leak rate of 9.5% (2 cases) with an overall mortality of 19.04% (4 cases) which included 2 cases with COVID-19 related ARDS. Conclusion(s): Our study was determined to analyse The effectiveness of single layer bowel repair and found that it is a quicker and theoretically better technique for bowel repair which avoids unnecessary tissue ischemia. The leakage rates within The study was comparable with other studies published and The studies with double layer bowel repair technique in terms of leak rates and mortality. A meticulously done single layer repair will best double layer repair and Surgical trainees must be trained early to perfect The art of bowel anastomosis.

9.
British Journal of Surgery ; 109(Supplement 5):v48, 2022.
Article in English | EMBASE | ID: covidwho-2134890

ABSTRACT

Aim: To present our learning-curve data for patients that underwent robotic-assisted Colorectal Surgery (RCRS) at a large NE London DGH. Method(s):Wereport our data from50initial Colorectal Cancer resections, performed by two surgeons. We report The gender, age, histopathology, Surgery performed, surgical time, conversion, post-operative complications, and hospital stay. Result(s): The first 50 patients who underwent RCRS between February 2020 and December 2021 for malignancy were included. Twenty-one were right hemicolectomies, 16 high anterior resection, 6 extended right hemicolectomies, 4 low anterior resections (including a planned robotic boari flap in 1 case by a trained urologist), 3 abdominoperineal excisions of rectum. The male to female ratio was 1:1 and The mean age was 65 (range: 22-85) years. The ASA class distribution was 4% ASA I, 64% ASA II, 32% ASA III. The median surgical time was 263 minutes (120-620) with median console time 136 minutes (50-540), The median hospital stay 5 days (range: 2-35) and a conversion rate of 6% (3/50 patients). The most common post-operative complications were ileus 4% (4/50), wound infection 6% (3/50), anastomotic leak 6% (3/50), and abscess formation 2% (1/50). 1 mortality occurred in a patient with an operated leak who contracted COVID-19. All patients underwent confirmed RO resections with a negative CRM. Conclusion(s): We report our first 50 robotic cases for Colorectal malignancy, showing that robotic-assisted Surgery can be performed with low rates of conversion 3 cases (6%) and low rates of postoperative complications despite a challenging patient demographic and a sharp learning curve.

10.
Journal of the American College of Surgeons ; 235(5 Supplement 1):S29-S30, 2022.
Article in English | EMBASE | ID: covidwho-2114912

ABSTRACT

INTRODUCTION: For treatment of Esophagectomy Complications Consensus Group (ECCG) type II leak, self-expanding metal stents (SEMS) can be placed, or endoscopic vacuum therapy (EVT) can be applied;however, there are no prospective data concerning the optimal endoscopic treatment strategy. The aim of the study was to report outcomes of treatment strategies for patients with an ECCG type II anastomotic leak after robotic-assisted minimally invasive esophagectomy (RAMIE). METHOD(S): All patients who developed an ECCG type II anastomotic leak since the introduction of RAMIE at our high-volume center (>200 cases/y) were included in the analysis. Time to EVT, duration of EVT, and follow-up treatment were analyzed for all patients. RESULT(S): Since 2017, a total of 157 patients have undergone a RAMIE at our clinic. Twenty-three patients developed an ECCG type II anastomotic leak (14.6% leak rate). Successful completion was achieved in 21 of 23 of patients (91%). Two patients were deceased before the completion of endoscopic therapy: 1 of unrelated COVID-19 pneumonia and 1 of sepsis with unknown focus. Mean duration of EVT was12 days (range 4 to 28 days), mean of 2 endoscopic sponge changes (range 0 to 5). Anastomotic leak was diagnosed at a mean of 9 days postoperative (range 2 to 19 days). Placement of a SEMS was performed in 5 patients (24%) after completion of EVT. No patient needed conversion to operative therapy;however, pre-emptive EVT was performed after surgical revision in 3 patients (37.5%) with an ECCG type III leak. CONCLUSION(S): EVT has been shown to be a safe and successful treatment option for anastomotic leak after robotic-assisted esophagectomy with success rate of 91% in our cohort. No additional surgical revision was performed in any patient.

11.
Iranian Red Crescent Medical Journal ; 24(2), 2022.
Article in English | EMBASE | ID: covidwho-1897320

ABSTRACT

Background: Anastomotic leakage (AL) is one of the common complications of colorectal surgeries. Shortening the hospitalization period due to the COVID-19 pandemic might be effective in the reduction of post-operative complications. Objectives: This study aimed to define the role of serum CRP, WBC, and body temperature (BT) in the detection of AL and the value of postoperative CRP levels in excluding AL. Methods: This study was a survey of laboratory tests. The patients with elective colorectal surgery were enrolled between 2017 and 2019. The symptoms of AL, such as high-level C-reactive protein, leukocytosis, body temperature, and ileus, were measured for five days after the surgery, and CRP levels were measured for five postoperative days to exclude anastomosis leakage. Results: In total, 315 patients were enrolled in this study. The mean age of the patients was 56.2 years. Anastomotic leakage was detected in 26 patients. The CRP values for AL on days 2, 3, 4, and 5 after surgery were significant (P<0.05). The CPR values below 44 mg/L and 27.2 mg/L were found to be significant for the exclusion of anastomosis leakage on postoperative days 2 and 4. Conclusion: Post-operative serum CRP, especially on postoperative days 2 and 4, with cut-off values of 44 mg/L and 27.2 mg/L, could be considered a highly sensitive marker to exclude AL and shorten the hospitalization period in the absence of ileus, fever, leukocytosis, and normal abdominal examination.

12.
Diseases of the Colon and Rectum ; 65(5):68-69, 2022.
Article in English | EMBASE | ID: covidwho-1893876

ABSTRACT

Purpose/Background: Studies suggest that COVID led to more advanced presentations of AD. However, there exists a paucity of information on the treatment modalities used and the outcomes of AD patients who were treated operatively during the pandemic surge and peaks in 2020. Hypothesis/Aim: We sought to determine the effect of COVID on A. the surgical management of AD patients and B. outcomes of these surgical patients with respect to postoperative complications. Methods/Interventions: We performed a retrospective analysis using data collected from our 350-bed community-based urban teaching hospital during 2018-2019 and 2020 to address this clinical question. Results/Outcome(s): There was no significant difference in the number of total colectomies for any diagnosis performed at our institu-tion (∼150/year) during the two time periods, with a similar percentage of these cases being secondary to diverticulitis in 2020 (28% vs 20%;p 0.07). The rate of elective vs urgent /emergent surgery for divertic-ulitis was similar in the two time periods. Of the diverticulitis patients treated operatively in 2020 vs the pre-COVID 2018-2019 period, a similar percentage were treated with resection and end colostomy/Hartmann procedure (HP;23% vs 24%, p > 0.05) and primary anasto-mosis (PA, 71% vs 63%, p > 0.05). Of the patients treated operatively in 2020, we found no statistical differences in the rate of anastomotic leak, return to OR, readmission, and death (p = 1.0, 1.0, 0.067. 0.41) compared to 2018-2019, although the rate of readmission approached significance with fewer patients readmitted during the pandemic in 2020. Limitations: Our study was limited only by single institution data and sample size. Conclusions/Discussion: These data support the conclusion that, despite the COVID-19 pandemic and the expectation of more advanced presentation of AD due to delays in care or patient reluctance, the presentation and surgical treatment of AD in our institu-tion was unaffected by the pandemic and complication rates did not increase. Although the sample size is small, this study suggests that, in contrast to other published studies, in our institution, the COVID pandemic had no effect on the management of AD and did not lead to worsened postoperative outcomes. Areas of future study will examine our hospital and city-wide COVID burden, as the study was conducted in an area with high rates of COVID compliance, vaccination, and did not experience a robust second or third COVID spike, which may have played a role in these data.

13.
World Journal of Laparoscopic Surgery ; 15(1):26-30, 2022.
Article in English | EMBASE | ID: covidwho-1863135

ABSTRACT

Background: Elective surgery, especially bariatric surgery, was stopped during the coronavirus disease-2019 (COVID-19) pandemic in the United Kingdom. Obesity is a major risk factor for COVID-19-related mortality. As the COVID-19 infection and mortality rates in Devon had been relatively low, bariatric procedures resumed with the necessary precautions in Plymouth with the easing of lockdown restrictions in mid-May. The aim of this study was to examine the outcome of bariatric surgery during the COVID-19 pandemic. Methods: Details of 38 patients, who underwent bariatric surgery between June 2020 and November 2020, were analyzed prospectively. All patients underwent a COVID-19 swab test 24–48 hours prior to the surgery. The primary outcome measure was COVID-19-related morbidity. Secondary outcomes were non-COVID-19-related morbidity, mortality, and weight loss at 6-week follow-up. Results: Thirty-eight patients [24 females;median age 51 (24–63) years, median body mass indices (BMI) at surgery 42.9 (32.4–62.5) kg/m2] underwent bariatric surgery. Thirty-seven patients were of White British ethnicity. No patient tested positive for COVID-19 pre-and postoperatively. No patient had any COVID-19-related morbidity or mortality. One patient developed a staple line bleed and returned to theater for relook laparoscopy and hemostasis. One patient developed an anastomotic leak and had a relook laparotomy for lavage and drain placement. The median length of hospital stay was 1 day. One patient was preplanned for intensive care admission and he stayed in a high dependency unit (HDU) for 1 day. All patients were followed up for 6 weeks and the median (range) excess weight loss (%EWL), at 6 weeks, was 24.4% (−0.9–53.6). Conclusion: Bariatric surgery can be performed safely in an area of low COVID-19 prevalence with the necessary precautions.

14.
Clinical Trials ; 18(SUPPL 5):36, 2021.
Article in English | EMBASE | ID: covidwho-1582568

ABSTRACT

Issue: Co-enrollment of patients in trials of complex interventions is an emerging phenomenon. Co-enrollment can provide efficiencies, pertinent in the era of a pandemic, but is not without issue. Management of patient co-enrollment, especially in trials investigating multiple interacting components, such as surgical randomized controlled trials, is considered. Setting: IntAct is an international surgical trial which has recruited throughout the COVID pandemic. It is a prospective, parallel group, randomized controlled trial comparing surgery with intraoperative fluorescence angiography against standard care (surgery alone) to determine the effect on anastomotic leak in patients undergoing resection for rectal cancer. Co-enrollment of patients has been requested by nine other trials to date, ranging from interventional drug trials to observational studies. There is minimal published literature regarding co-enrollment to inform discussion and decision-making by the IntAct Trial Management group. Background: Co-enrollment of patients in clinical trials poses a number of potential issues spanning ethical, safety, statistical, and practical concepts, which require careful consideration. Effort has been made to quantify the potential impacts of co-enrollment on statistical power (Myles, 2014). For example, the interaction of treatment effects and substantial or imbalanced co-enrollment have been shown to possess the potential for a large detrimental effect on the sample size. In practice, the nature of such an interaction, or the level of co-enrollment, will not be known in advance. Furthermore, where the intervention is complex in nature, such as in surgical trials of multiple component parts like IntAct, not only is there the possibility of an interaction between the treatment effects of co-enrolling interventions, but also of how the co-enrolling intervention may alter the individual intervention components. There is no published guidance on how to assess these risks a priori. Nonetheless, there are also many potential benefits to allowing co-enrollment. These include increased availability of research opportunities to patients and increased efficiencies to sites when patients contribute to multiple research projects. Disallowing co-enrollment could pose a risk to a trial's recruitment by narrowing the pool of potential participants. Likewise, there is no published guidance on how to assess these benefits a priori. Key considerations for co-enrolling trials: the IntAct Trial Management group decision-making process was informed by discussions regarding: • Internal validity: the ability of the co-enrolling intervention to change the typical operative setting, as well as the post-operative care pathway. • Potential interaction of treatment effects: particularly with regard to the primary endpoint and participant safety. • Generalizability: the possible implications for the trial results. • Recruitment impact: the probable restrictions imposed if co-enrollment was disallowed. • Compliance: the likely effects of co-enrollment on data collection, follow-up visits and withdrawal, and ethical considerations of overburdening participants. We present our rationale and recommendations for guiding Trial Management group discussions when considering and approving co-enrollment of patients in clinical trials. By presenting the experiences of the IntAct international surgical trial Trial Management group, we provide a practical reference for trials considering co-enrollment.

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