Randomized clinical trials

Tan J, Ryan EJ, Davey MG, McHugh FT, Creavin B, Whelan MC et al.

BJS Open 2023; 7: zrad040.

A total of 60 RCTs was included in the analysis. Optimal results were achieved with or without mechanical bowel preparation, but with intravenous antibiotics and oral antibiotics.

Comment: Perhaps the final word, and interesting that antibiotics were more important than bowel preparation.

Balzano G, Zerbi A, Aleotti F, Capretti G, Melzi R, Pecorelli N et al.

Ann Surg 2023; 277: 894-903.

Total pancreatectomy (TP) was associated with reduced perioperative morbidity: 60 versus 90.3%, P=0.008, and similar hospital stay, in this study that included 61 procedures. Survival rates were also similar, but TP was associated with a higher risk of diabetes.

Comment: Intriguing, and could lead to a change in standard care.

Santos A, Mentula P, Pinta T, Ismail S, Rautio T, Juusela R et al.

JAMA Surg 2023; 158: 593-601. 

Eighty-five patients were included in this planned analysis. After two years, 25/44 patients in the conservative group had recurrent diverticulitis and eight required sigmoid colectomy. Four patients who had surgery had recurrent diverticulitis. G.I. quality of life was similar between the two groups.

Comment: Useful interim information.

Molenaar CJL, Minnella EM, Coca-Martinez M, ten Cate DWG, Regis M, Awasthi R et al, for the PREHAB Study Group.

JAMA Surg 2023; 158: 572-581.

The study included 251 participants, who mostly had laparoscopic or robotic resection. A 4-week supervised, multimodal prehabilitation programme reduced severe postoperative complications: 17.1 versus 29.7 per cent, P=0.02. Prehabilitation generally improved functional capacity up to four weeks postoperatively.

Comment: More evidence that a good recovery from surgery starts well before hospital admission.

Enzmann FK, Nierlich P, Hölzenbein T, Aspalter M, Kluckner M, Hitzl W et al.

Ann Surg 2023; 277: e1208-e1214.

The study included 218 legs in 209 patients. After four years, there was no difference in patency, limb survival or complications, but patients who had a surgical bypass reported greater clinical improvement.

Comment: More fuel for the debate started by the and BESTCLI and BASIL trials.

Lu X, Jiang J, Shen Z, Chen G, NP YW, Xiao X et al.

Ann Surg 2023; 277: e1200-e1207.

A total of 200 babies with Kasai disease were randomly allocated adjuvant steroids after portoenterostomy. After six months, the proportion of babies who were jaundice-free and had avoided liver transplantation was higher in those treated with steroids: 54.1 versus 31 per cent, P=0.0015.

Comment: Should become routine care.

Fawzy A, Balbaa MA, Hagag M.

BJS Open 2023; 7: zrac173.

There was no difference in the rate of patient satisfaction between these two procedures in the 78 patients studied. Most patients in both groups considered the result excellent.

Comment: Both these new techniques are effective.

Coles CE, Haviland JS, Kirby AM, Griffin CL, Sydenham MA, Titley JC et al, on behalf of the IMPORT Trial Management Group.

Lancet 2023; 401: 2124-2137.

A total of 2617 women were enrolled in the trial. Concomitant booster irradiation was safe, with similar rates of local recurrence: 2 per cent and 3.2 per cent in the different dosages, compared to 1.9 per cent in controls. Simultaneous booster irradiation reduced patient visits.

Comment: Easier for the women, and should improve treatment scheduling.

Schrag D, Uno H, Rosovsky R, Rutherford C, Sanfilippo K, Villano JL et al, for the CANVAS Investigators.

JAMA 2023; 329: 1924-1933.

This study included 671 patients with cancer and a new episode of VTE. After six months, the risk of recurrent VTE was not inferior with oral anticoagulation (6.1per cent), compared to those receiving low molecular weight heparin (8.8 per cent). Bleeding complication rates were similar.

Comment: Reassuring, and easier for patients.

Maemoto R, Noda H, Ichida K, Miyakura Y, Kakizawa N, Machida E et al.

Ann Surg 2023; 277: 727-733.

Lavage with povidone iodine before skin closure for 1 min was compared to saline lavage in this study that included 941 procedures. The rate of surgical site infection was similar: 7.6 per cent with iodine and 5.1 per cent with saline, P=0.154.

Comment: the fact that the wound is flushed may be more important than what with.

D’Angelica MI, Ellis RJ, Liu JB, Brajcich BC, Gonen M, Thompson VM et al.

JAMA 2023; 329: 1579-1588.

The trial was stopped after interim analysis of 778 procedures. The combination of piperacillin and tazobactam reduced the risk of surgical site infection at 30 days: 19.8 versus 32.8 per cent, P<0.001. It also reduced the rate of relevant postoperative pancreatic fistula: 12.7 versus 19 per cent, P=0.03.

Comment: Promising new combination for open pancreatic surgery.

Piatkowski AA, Wederfoort JLM, Hommes JE, Schop SSJ, Krastev TK, van Kuijk SMJ et al, for the Breast Reconstruction With External Preexpansion & Autologous Fat Transfer vs Standard Therapy (BREAST) Trial Investigators.

JAMA Surg 2023; 158: 456-464.

There was no evidence that fat transfer was unsafe in this study that included 193 women. Quality of life was improved in all five domains in women who had the fat transfer procedure in the 132 women who completed the study (all domains P<0.05). There were no differences in complications or oncological outcomes.

Comment: Less invasive than breast reconstruction.

Etoh T, Ohyama T, Sakaramoto S, Tsuji T, Lee S-W. Yoshida K et al,  for the Japanese Laparoscopic Surgery Study Group (JLSSG).

JAMA Surg 2023; 158: 445-454.

After five years in this study that included 502 patients, there was no difference between the two procedures in relapse-free survival: 73.9 per cent open versus 75.5 per cent laparoscopic resection, P=0.03 for non inferiority. Nor were there differences in postoperative complications, or overall survival.

Comment: No difference in outcomes, so choice of procedure should be according to patient choice, but perhaps also cost in publicly funded healthcare systems.

Gerard J-P, Barbet N, Schiappa R, Magne N, Martel I, Mineur L et al, on behalf of the ICONE group.

Lancet Gastrohepatol 2023; 8: 356-367.

This study explored whether a radiotherapy booster was beneficial in 148 patients with a complete response to neoadjuvant chemoradiotherapy. Three-year preservation of the rectum was more likely after contact brachytherapy (81 per cent) versus 59 per cent for booster external beam radiotherapy, P=0.0026. The effect was greatest for tumours <3cm in diameter.

Comment: Management of rectal tumours with the aim to avoid ablative surgery is evolving.

Verrastro O, Panunzi S, Castagneto-Gissey L, De Gaetano A, Lembo E, Capristo E et al.

Lancet 2023; 401: 1786-1797.

A total of 288 patients were randomly allocated to best medical therapy or one of two bariatric procedures. Stereohepatitis resolved in 70  per cent of patients who had either Roux-en-Y gastric bypass or sleeve gastrectomy compared to 19 per cent in the best medical treatment group; P<0.0001.

Comment: This study shows convincing evidence that non-alcoholic fatty liver can be reversed by bariatric surgery. Is that alone a reasonable indication?

Gasior SA, O’Donnell JPM, Davey M, Clarke J, Jalali A, Ryan E et al.

Eur J Vasc Endovasc Surg 2023; 65: 690-699.

Over 14000 people were included  in this analysis. It concluded modern best medical therapy had similar reductions in stroke and death rates to carotid endarterectomy. It was not possible to define any subgroups that might benefit from vascular intervention.

Comment: complex and detailed study undermining the previously agreed role of vascular intervention.

Bekken JA, Vroegindeweij D, Vos JA, de Vries J-PPM, Lardenoije JWHP, Petri B-J et al.

Eur J Vasc Endovasc Surg 2023; 65: 359-368.

Freedom from restenosis after two years was 84.7 per cent after bare stents versus 89.1 per cent with covered stents (P=0.4) in this study that included 174 limbs. Technical success and complication rates were similar.

Comment: no advantage for the covered stent.

Gunnarson T, Bergman S, Parsson H, Gottsater A, Lindgren H.

Eur J Vasc Endovasc Surg 2023; 65: 513-519.

In this study that included 100 patients, after 30 months, insertion of a stent improved role physical quality of life (QoL) scores, but not overall QoL, compared to best medical therapy. By 60 months QoL was similar in the two groups.

Comment: endovascular intervention for SFA disease is not a good long term solution.

Serradilla-Martín M, Paterna-López S, Palomares-Cano A, Cantalejo-Díaz M, Abadía-Forcén T, Gutiérrez-Díez ML, et al.

BJS Open 2023; 7: zrad028.

Use of the patch reduced the rate of clinically relevant postoperative pancreatic fistula by 90 per cent; odds ratio 0.1, 95 per cent confidence interval 0.01 to 0.89, P=0.039, in this study that included 64 procedures.

Comment: amazing result, but relatively small series.

Pfister M, Probst P, Muller PC, Antony P, Klotz R, Kalkum E et al. 

BJS Open 2023; 7: zrad007.

This study included 984 patients from six RCTs. Minimally invasive surgery reduced blood loss, surgical site infection (odds ratio 0.4, 95 per cent confidence interval 0.1 to 0.96, P=0.04) and hospital stay by 1.3 days (-2 to -0.5, P=0.001). On average the surgery took 75 minutes longer, P<0.001.

Comment: this is a common result for laparoscopic versus open surgery studies, but a definitive comparison includes late outcomes in cancer cases, and costs (see also Sattari et al).

Sattari SA, Sattari AR, Makary MA, Hu C, He J.

Ann Surg 2023; 277: 742-755.

Four RCTs including 818 procedures were studied. The laparoscopic procedure took longer, but was associated with less blood loss, fewer surgical site infections and reduced length of hospital stay: mean 2.5 days, P=0.06.

Comment: this is a common result for laparoscopic versus open surgery studies, but a definitive comparison includes late outcomes in cancer cases, and costs (see also Pfister et al).

Bradbury AW, Moakes CA, Popplewell M, Meecham L, Bate GR, Kelly L et al, on behalf of the BASIL-2 Investigators.

Lancet 2023; 401: 1798-1809.

Some 345 patients with critical leg ischaemia were treated and followed for two years. The outcome of major amputation or death occurred in  63 per cent of the surgery first group compared to 53 per cent after endovascular treatment first, P=0 .037. This outcome was mainly due to the high rate of death in the two years after surgery (53 versus 45 per cent).

Comment: This was an unexpected result after the converse outcome in the recent BestCLI trial. It requires further explanation. Were the patients with critical leg ischaemia different in the UK and USA?

Lim AJM, Abduraheem HM, Hitchman LH, Lathan R, Bharadhwaj R, Sidapra MM et al.

Br J Surg 2023; 110: 562-567.  

Four randomized trials including 654 patients were analyzed. The rate of occlusions was lower after mechanical ablation: risk ratio of 0.85, 95 per cent confidence interval 0.78 to 0.91, P<0.000. There was no difference in pain during the procedure or clinical outcomes.

Comment: The role of mechanical ablation remains unproven. It doesn’t seem as effective as endothermal ablation, although the occlusion rate as an endpoint may not be ideal.

Mei W-J, Wang X-Z, Li Y-F, Sun Y-M, Yang C-K, Lin J-Z et al.

Ann Surg 2023; 277: 557-564.

In this study that included 589 procedures, neoadjuvant chemotherapy with radiotherapy had similar effect on complete pathological response and downstaging. Radiotherapy increase the risk of needing an ileostomy: 63.6 versus 52.2 per cent, P= 0.008.

Comment: The late outcomes of this trial will reveal whether additional radiotherapy is worthwhile.

Bouzat P, Charbit J, Abback P-S, Huet-Garrigue D, Delhaye N, Leone M et al, for the PROCOAG Study Group.

JAMA 2023; 329: 1367-1375.

In this study of 327 injured patients, use of the prothrombin complex did not reduce the need for blood transfusion within the first 24 hours: 12 versus 11 units, P=0.72. It did increase the risk of thrombotic events by around 11% , P=0.03

Comment: Disappointing results.

Early Breast Cancer Trialists’ Collaborative Group (EBCTCG).

Lancet 2023; 491: 1277-1292.

This huge analysis of women treated for breast cancer showed that the combination of anthracycline and taxane regimens was most effective at reducing breast cancer recurrence. The higher dose regimens produced the greatest effects.

Comment: I really admire this sort of analysis which provides very important information that influences treatment strategies.

Kumar P, Sarthak S, Singh P, Mishra TS, Sasmal PK.

J Am Coll Surg 2023; 236: 27-35.

This study included 84 patients. The healing rate after six moths was better with the tract ligation method: 76.2 versus 54.7 per cent, P=0.039. All patients were continent at two years.

Comment: Promising, but bigger trials needed.

Ghaneh P, Palmer D, Cicconi S, Jackson R, Halloran CM, Rawcliffe C et al, for the European Study Group for Pancreatic Cancer.

Lancet Gastro Hepatol 2023; 8: 157-168.

This study included 83 evaluable patients from 478 screened. Neoadjuvant treatment did not reduce the resection rate. Neoadjuvant treatment improved 1-year disease-free survival in both groups combined: 59 versus 39% for immediate surgery (hazard ratio 0.53, 95 per cent confidence interval 0.28 to 0.98, P=0.016.

Comment: The evidence for neoadjuvant chemotherapy is accumulating, but the number of suitable patients may be small.

Patel SP, Othus M, Chen Y, Wright GP, Yost KJ, Hyngstrom JR et al.

N Engl J Med 2023; 388: 813-823.

Some 313 patients with advanced melanoma undergoing surgical resection followed by one year of adjuvant Pembrolizumab, were randomly allocated three additional doses of Pembrolizumab preoperatively. After two years, event-free survival was significantly better with the neoadjuvant treatment: 72 versus 49 per cent, P=0.004.

Comment: This is important evidence for the benefit of neoadjuvant treatment for melanoma.

van der Veen A, van der Meulen MP, Seesing MFJ, Brenkman HJF, Haverkamp L, Luyer MDP et al. for the Laparoscopic vs Open Gastrectomy for Gastric Cancer (LOGICA) study group.

JAMA Surg 2023; 158:120-128.

A total of 227 procedures were included. Costs of initial surgery were higher for laparoscopic compared with open procedures, but by one year there was only a 3 per cent cost difference between the interventions.

Comment: Surprisingly little difference. Justifies either approach.

Kimball AB, Jemec GBE, Alavi A, Reguiai Z, Gottlieb AB, Bechara FG et al.

Lancet 2023; 401: 747-761.

This analysis of two identical trials included over one thousand patients. Secukinumab given fortnightly was more effective in both trials at reducing the signs of symptoms of hidradenitis than placebo (or Secukinumab every four weeks).

Comment: Effective, with good safety profile.

Lee SY, Lee J, Park H-M, Kim CH, Kim HR.

Ann Surg 2023; 277: 381-386.

The study included 176 patients awaiting colon cancer surgery. Preoperative immunonutrition did not reduce the risk of infectious complications (17.7 versus 15.9 per cent in controls) or overall complications (31.6 versus 29.3 per cent).

Comment: Not justified.

The TRACE Study Investigators.

Ann Surg 2023; 277: 375-380.

Over 5000 patients were included in this multicentre trial. Thirty-day mortality was 0.56 per cent  (n = 14) in the control and 0.44 per cent (n = 12) in the intervention group (odds ratio 0.74, 95% Confidence interval 0.34–1.62).

Comment: Would results have been different if the focus had been on high risk patients only?

Jain A, Greig AVH, Jones A, Cooper C, Davies L, Greshon A for the NINJA Collaborative.

Br J Surg 2023, 110: 432-438.

In this study that included 451 children, discarding the nail after repair was not associated with an inferior outcome (infection/cosmesis), but reduced overall costs by a mean of 84 euros.

Comment: The nail can be discarded.

Almeida I, Gonqalves AC, Corrêa FB, Castro J, Guirro E, Farina JA et al.

Ann Surg 2023; 277: 198-205.

Patients with burn contractures at least one year old were randomized to split skin grafting alone, or with the addition of one of three dermal matrix preparations. Detailed scar assessment showed no improvement over skin grafting alone with any of the dermal matrices.

Comment: Disappointing outcome for the dermal matrices.