Systematic review on reporting of components and outcomes in randomized clinical trials of paraoesophageal hernia mesh repair.

BACKGROUND: Surgical interventions, such as paraoesophageal hernia (POH) repair, are complex with multiple components that require consideration in the reporting of clinical trials. Many aspects of POH repair, including mesh hiatal reinforcement and fundoplication type, are contentious. This review summarizes the reporting of components and outcomes in RCTs of POH repair. METHODS: Systematic searches identified RCTs of POH repair published from 1995 to 2020. The patient selection criteria for RCT involvement were noted. The components of the surgical interventions in these RCTs were recorded using the CONSORT guidelines for non-pharmacological treatments, Template for Intervention Description and Replication (TIDieR) and Blencowe frameworks. The outcomes were summarized and definitions sought for critical variables, including recurrence. RESULTS: Of 1918 abstracts and 21 screened full-text articles, 12 full papers reporting on six RCTs were included in the review. The patient selection criteria and definitions of POH between trials varied considerably. Although some description of trial interventions was provided in all RCTs, this varied in depth and detail. Four RCTs described efforts to standardize the trial intervention. Outcomes were reported inconsistently, were rarely defined fully, and overall trial conclusions varied during follow-up. CONCLUSION: This lack of detail on the surgical intervention in POH repair RCTs prevents full understanding of what exact procedure was evaluated and how it should be delivered in clinical practice to gain the desired treatment effects. Improved focus on the definitions, descriptions and reporting of surgical interventions in POH repair is required for better future RCTs.

Evaluation of an early-stage innovation for full-thickness excision of benign colonic polyps using the IDEAL framework.

AIMS: Colectomy is the current approach for patients with endoscopically unresectable benign polyps but risks considerable morbidity. Full-thickness laparoendoscopic excision (FLEX) is a novel procedure, specifically developed to treat endoscopically unresectable benign colonic polyps, which could reduce the treatment burden of the current approach and improve outcomes. However, traditional evaluations of surgical innovations lack methodological rigour. This study reports the development and feasibility of the FLEX procedure in selected patients. METHOD: A prospective development study using the Idea, Development, Evaluation, Assessment, Long-term study (IDEAL) framework was undertaken, by one surgeon, of the FLEX procedure in selected patients with endoscopically unresectable benign colonic polyps. Three-dimensional (3D)-CT colonography reconstructions were used preoperatively to rehearse patient-specific, critical manoeuvres. Targetted, full-thickness excision was performed: after marking the margin of the caecal polyp using circumferential endoscopic argon plasma coagulation, transmural endoscopic sutures were used to evert the bowel and resection was undertaken by laparoscopic linear stapling. Feasibility outcomes (establishing 'local success') included evidence of complete polyp resection without adverse events (especially safe closure of the excision site). RESULTS: Ten patients [median (interquartile range) age: 74 (59-78) years] with polyp median diameters of 35 (30-41) mm, were referred for and consented to receive the FLEX procedure. During the same time frame, no patient underwent colectomy for benign polyps. One further patient received FLEX for local excision of a presumed malignant polyp because severe comorbidity prohibited standard procedures. The FLEX procedure was successfully performed locally, with complete resection of the polyp and safe closure of the excision site, in eight patients. Three noncompleted procedures were converted to laparoscopic segmental colectomy under the same anaesthetic because of endoscopic inaccessibility (two patients) and transcolonic suture failure (one patient). CONCLUSIONS: The FLEX procedure is still under development. Early data demonstrate that it is safe for excision of selected benign polyps. Modifications to transcolonic suture delivery are now required and there is a need for wider adoption before more definitive evaluation can be performed.

Network meta-analysis of protocol-driven care and laparoscopic surgery for colorectal cancer.

BACKGROUND: Laparoscopic approaches and standardized recovery protocols have reduced morbidity following colorectal cancer surgery. As the optimal regimen remains inconclusive, a network meta-analysis was undertaken of treatments for the development of postoperative complications and mortality. METHODS: MEDLINE, Embase, trial registries and related reviews were searched for randomized trials comparing laparoscopic and open surgery within protocol-driven or conventional perioperative care for colorectal cancer resection, with complications as a defined endpoint. Relative odds ratios (ORs) for postoperative complications and mortality were estimated for aggregated data. RESULTS: Forty trials reporting on 11 516 randomized patients were included with the network. Open surgery within conventional perioperative care was the index for comparison. The OR relating to complications was 0·77 (95 per cent c.i. 0·65 to 0·91) for laparoscopic surgery within conventional care, 0·69 (0·48 to 0·99) for open surgery within protocol-driven care, and 0·43 (0·28 to 0·67) for laparoscopic surgery within protocol-driven care. Sensitivity analyses excluding trials of low rectal cancer and those with a high risk of bias did not affect the treatment estimates. Meta-analyses demonstrated that mortality risk was unaffected by perioperative strategy. CONCLUSION: Laparoscopic surgery combined with protocol-driven care reduces colorectal cancer surgery complications, but not mortality. The reduction in complications with protocol-driven care is greater for open surgery than for laparoscopic approaches. Registration number: CRD42015017850 (https://www.crd.york.ac.uk/PROSPERO).

Outcomes following laparoscopic rectal cancer resection by supervised trainees.

BACKGROUND: The aim was to evaluate the applicability of laparoscopic surgery in the treatment of primary rectal cancer in a training unit. METHODS: A cohort analysis was undertaken of consecutive patients undergoing elective surgery for primary rectal cancer over a 7-year interval. Data on patient and operative details, and short-term clinicopathological outcomes were collected prospectively and analysed on an intention-to-treat basis. RESULTS: A total of 306 patients (213 men, 69·6 per cent) of median (i.q.r.) age 67 (58-73) years with a median body mass index of 26·6 (23·9-29·9) kg/m(2) underwent surgery. Median tumour height was 8 (6-11) cm from the anal verge, and 46 patients (15·0 per cent) received neoadjuvant radiotherapy. Seven patients (2·3 per cent) were considered unsuitable for laparoscopic surgery and underwent open resection; 299 patients (97·7 per cent) were suitable for laparoscopic surgery, but eight were randomized to open surgery as part of an ongoing trial. Some 291 patients (95·1 per cent) underwent a laparoscopic procedure, with conversion required in 29 (10·0 per cent). Surgery was partially or completely performed by trainees in 72·4 per cent of National Health Service patients (184 of 254), whereas private patients underwent surgery primarily by consultants. Median postoperative length of stay for all patients was 6 days and the positive circumferential resection margin rate was 4·9 per cent (15 of 306). CONCLUSION: Supervised trainees can perform routine laparoscopic rectal cancer resection.

Influence of body composition profile on outcomes following colorectal cancer surgery.

BACKGROUND: Muscle depletion is characterized by reduced muscle mass (myopenia), and increased infiltration by intermuscular and intramuscular fat (myosteatosis). This study examined the role of particular body composition profiles as prognostic markers for patients with colorectal cancer undergoing curative resection. METHODS: Patients with colorectal cancer undergoing elective surgical resection between 2006 and 2011 were included. Lumbar skeletal muscle index (LSMI), visceral adipose tissue (VAT) surface area and mean muscle attenuation (MA) were calculated by analysis of CT images. Reduced LSMI (myopenia), increased VAT (visceral obesity) and low MA (myosteatosis) were identified using predefined sex-specific skeletal muscle index values. Univariable and multivariable Cox regression models were used to determine the role of different body composition profiles on outcomes. RESULTS: Some 805 patients were identified, with a median follow-up of 47 (i.q.r. 24·9-65·6) months. Multivariable analysis identified myopenia as an independent prognostic factor for disease-free survival (hazard ratio (HR) 1·53, 95 per cent c.i. 1·06 to 2·39; P = 0·041) and overall survival (HR 1·70, 1·25 to 2·31; P < 0·001). The presence of myosteatosis was associated with prolonged primary hospital stay (P = 0·034), and myopenic obesity was related to higher 30-day morbidity (P = 0·019) and mortality (P < 0·001) rates. CONCLUSION: Myopenia may have an independent prognostic effect on cancer survival for patients with colorectal cancer. Muscle depletion may represent a modifiable risk factor in patients with colorectal cancer and needs to be targeted as a relevant endpoint of health recommendations.

An analysis of the accuracy of computed tomography colonography when defining anatomy for novel full-thickness colonic excision techniques in early colonic neoplasia.

AIM: Full-thickness laparo-endoscopic excision (FLEX) is a new technique developed for the full-thickness excision of colonic adenomas and, potentially, early cancer, avoiding the need for colectomy. FLEX requires accurate preoperative characterization of three key morphological features of the tumour, including its relation to the mesenteric border, its diameter and the circumferential extent of involvement of the bowel wall. This study evaluated the accuracy of CT colonography (CTC) for the assessment of these features in early colonic tumours. METHOD: Consecutive patients undergoing CTC prior to colonic resection for complex benign polyps or UICC Stage 1 cancer were retrospectively analysed by two specialist gastrointestinal radiologists blinded to the subsequent histopathological findings. The location of the tumour in relation to the mesenteric border, its maximum diameter and the circumferential extent of involvement of the colonic wall were correlated with the histopathological examination of the surgical resection specimen. Pearson's correlation coefficient (r) and Kappa agreement (κ) were used to compare the maximum diameter and the circumferential extent of involvement of the colonic wall. RESULTS: Twenty-eight patients with early colonic neoplasia were included. All had had a surgical segmental resection. Four had a benign adenoma and 24 had a TNM Stage 1 cancer. Histopathological assessment of the resected surgical specimen showed that 21 of the 28 lesions were located on the mesenteric border. The median diameter was 35 (interquartile range 28-42) mm; 13 lesions involved less than one-third of the circumference, 11 between one and two-thirds and four more than two-thirds. CTC correctly identified the location of the lesion in relation to the mesenteric border in all 28 cases. Correlation between CTC and histopathology was good for the assessment of the maximum diameter of the lesion (r = 0.81) and the circumferential extent of involvement of the colonic wall (κ = 0.76). CONCLUSION: CTC can accurately assess the key morphological features for the selection of patients with early colonic neoplasia for full-thickness laparo-endoscopic excision.

Upper gastrointestinal training in the UK and Ireland: a Roux Group Study.

INTRODUCTION: Surgical training programmes in the United Kingdom and Ireland (UK&I) are in a state of flux. This study aims to report the contemporary opinions of trainee and consultant surgeons on the current upper gastrointestinal (UGI) training model in the UK&I. METHODS: A questionnaire was developed and distributed via national UGI societies. Questions pertained to demographics, current training evaluation, perceived requirements and availability. RESULTS: A total of 241 responses were received with representation from all UK&I postgraduate training regions. The biggest discrepancies between rotation demand and national availability related to advanced/therapeutic endoscopy and robotic surgery, with 91.7% of respondents stating they would welcome greater geographical flexibility in training. The median suggested academic targets were 3-5 publications (trainee vs consultant <3 vs 3-5, p<0.001); <3 presentations (<3 vs 3-5, p=0.002); and 3-5 audits/quality improvement projects (<3 vs 3-5, p<0.001). Current operative requirements were considered achievable (87.6%) but inadequate for day one consultant practice (74.7%). Reassuringly, 76.3% deemed there was role for on-the-job operative training following consultant appointment. Proficiency in diagnostic endoscopy was considered a minimum requirement for Certificate of Completion of Training (CCT) yet the majority regarded therapeutic endoscopy competency as non-essential. The median numbers of index UGI operations suggested were comparable with the current curriculum requirements. Post-CCT fellowships were not considered necessary; however, the majority (73.6%) recognised their advantage. CONCLUSIONS: Current CCT requirements are largely consistent with the opinions of the UGI community. Areas for improvement include flexibility in geographical working and increasing national provisions for high-quality endoscopy training.

The impact of the two-week wait referral pathway on rectal cancer survival.

AIM: The aim of this study was to compare the outcome of patients with rectal cancer referred through the two-week wait (TWW) system with those identified by routine referral pathways (non-TWW). METHOD: A prospective study was carried out of 125 consecutive patients diagnosed with rectal cancer between January 2000 and December 2005 (6 years) in one district general hospital. Data were recorded prospectively in a local clinicopathological registry. The patients were divided into two groups: group 1 (TWW) and group 2 (routine referral pathway). RESULTS: Fifty-two (41%) of the 125 patients were diagnosed through the TWW (group 1). There was no significant difference in patient demographics, including baseline tumour characteristics, between the two groups. There was no difference in preoperative or postoperative T stage between the two groups (P = 0.63). There was no significant difference in circumferential margin positivity (five of 52 in group 1 vs four of 73 in group 2; P = 0.52) or local recurrence rates (P = 0.37). The 5-year all-cause mortality was 49% for group 1 and 52% for group 2 (P = 0.3). The overall disease-free survival was similar in the two groups (1521 days for group 1 vs 1591 days for group 1, P = 0.29). CONCLUSION: Referral under the TWW strategy does not translate into improved survival in rectal cancer.

Validation of the size morphology site access score in endoscopic mucosal resection of large polyps in a district general hospital.

BACKGROUND: Polyp assessment is multimodal and is vital prior to endoscopic mucosal resection. The size, morphology, site and access (SMSA) score has been validated in specialist endoscopic institutions. this study investigated the ability of this score to predict incomplete endoscopic resection of large colorectal polyps in a district general hospital. METHODS: Consecutive patients undergoing endoscopic mucosal resection of large (≥ 20 mm) colorectal polyps at Worthing Hospital. Clinical, endoscopic and histological data were taken from prospective databases. The primary outcome of the study was to investigate the correlation of the SMSA score with incomplete endoscopic resection. RESULTS: Between February 2015 and August 2018, 114 patients underwent colorectal endoscopic mucosal resection. Of these, 67 (59%) were male. The median (interquartile range) age of the study population was 72 years (65-78 years). Some 17 lesions (15%) were pedunculated, 76 (67%) were sessile and 21 were (18%) flat; 84 polyps (77%) were located in the left colon/rectum, with the remainder in the right colon; 51 lesions (45%) were 20-30 mm, 27 (24%) were 30-40 mm and 36 (31%) were greater than 40 mm in diameter. When reclassified into the SMSA score, 9 of the polyps (8%) were level 2, 64 (56%) were level 3 and 41 (36%) were level 4. Incomplete resection was clinically diagnosed in 9/114 (8%). The SMSA score was positively correlated with incomplete endoscopic resection, but not with additional procedure usage, complications or advanced histology. CONCLUSIONS: Many patients with large polyps can be managed outside of specialist units. This study has validated that the SMSA score was associated with incomplete endoscopic mucosal resection for large polyps in a district general hospital setting.

A pilot study to assess near infrared laparoscopy with indocyanine green (ICG) for intraoperative sentinel lymph node mapping in early colon cancer.

BACKGROUND: Previous attempts at sentinel lymph node (SLN) mapping in colon cancer have been compromised by ineffective tracers and the inclusion of advanced disease. This study evaluated the feasibility of fluorescence detection of SLNs with indocyanine green (ICG) for lymphatic mapping in T1/T2 clinically staged colonic malignancy. METHODS: Consecutive patients with clinical T1/T2 stage colon cancer underwent endoscopic peritumoral submucosal injection of indocyanine green (ICG) for fluorescence detection of SLN using a near-infrared (NIR) camera. All patients underwent laparoscopic complete mesocolic excision surgery. Detection rate and sensitivity of the NIR-ICG technique were the study endpoints. RESULTS: Thirty patients mean age = 68 years [range = 38-80], mean BMI = 26.2 (IQR = 24.7-28.6) were studied. Mesocolic sentinel nodes (median = 3/patient) were detected by fluorescence within the standard resection field in 27/30 patients. Overall, ten patients had lymph node metastases, with one of these patients having a failed SLN procedure. Of the 27 patients with completed SLN mapping, nine patients had histologically positive lymph nodes containing malignancy. 3/9 had positive SLNs with 6 false negatives. In five of these false negative patients, tumours were larger than 35 mm with four also being T3/T4. CONCLUSION: ICG mapping with NIR fluorescence allowed mesenteric detection of SLNs in clinical T1/T2 stage colonic cancer. CLINICALTRIALS.GOV: ID: NCT01662752.

An analysis of the natural course of compensatory sweating following thoracoscopic sympathectomy.

BACKGROUND: To evaluate the long-term results of thoracoscopic sympathectomy in the treatment of hyperhydrosis. METHODS: Theatre log books were used to identify all patients who underwent thoracoscopic sympathectomy between 2000 and 2006. Details of pre-operative symptoms, surgical procedure and post-operative complications were collected from the patient notes. Each patient was sent a questionnaire regarding success of the procedure, compensatory sweating and overall satisfaction. RESULTS: 46 hyperhydrosis patients (34 females) age range 14-57 years. 20 patients suffered with hyperhydrosis in a combination of areas, 14 in the axillae alone, 9 palms alone and with 2 facial symptoms. There were 2 early post-operative complications, 1 haemothorax which required a chest drain and a chest infection. 3 patients required redo procedures. Of follow-up of 42 months (range 6-84), 32 (69·5%) patients reported complete dryness or a significant improvement in symptoms and 15 a substantial improvement in quality of life. However 43 patients (93%) suffered with compensatory sweating, of these 27 had to change clothes more than once daily. Compensatory sweating was graded as severe in 18 and incapacitating in 2. Of note only 5 patients noticed an improvement in the compensatory sweating over time. Only 26 (56%) would recommend thoracoscopic sympathectomy to others with hyperhydrosis. CONCLUSION: Thoracoscopic sympathectomy is effective in the treatment of hyperhydrosis. However compensatory sweating seems unavoidable and infrequently improves with time. Patients need to be carefully counselled before committing to surgery.