Randomized clinical trials

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.

Kurokawa Y, Doki Y, Mizusawa J, Yoshikawa T, Yamada T, Kimura Y et al.

Br J Surg 2023; 110: 50–56.

This study that was terminated early after interim analysis, included 1204 procedures. The addition of total resection of the bursa omentalis did not improve overall 5-year survival compared to omentectomy alone: 74.9 versus 76.5 per cent respectively, P=0.59.

Comment: The limitations of extended surgery.

Lin J-X, Lin J-P, Wang Z_K, Li P, Xie J-W, Wang J-B et al.

JAMA Surg 2023; 158: 10-18.

In this study that included 526 patients with proximal gastric cancer that had not invaded the greater curvature, the studied procedure did not improve 3-year disease-free survival compared to standard gastrectomy: 70.3 vs. 64.3 per cent, respectively, P=0.11).

Comment: Subgroup analysis suggested that patients with advanced posterior gastric cancer may benefit from this procedure.

Son S, Hur H, Hyung WJ, Park Y-K, Lee H-J, Aj JY et al.

JAMA Surg 2022; 157: 879-886.

Some 1050 patients were originally included. After five years, overall survival was similar: open 88.7 per cent versus laparoscopic 88.9 per cent. Late intestinal obstruction was more common after open surgery: 5 versus 2.6 per cent.

Comment: Confirms published three year results that the laparoscopic approach can be recommended.

de-Madaria E, Buxbaum JL, Maisonneuve P, de Paredes AGG, Zapater P, Guilabert et al for the ERICA Consortium.

N Engl J Med 2022; 387: 989-1000.

This trial was stopped early after interim analysis of 249 patients. Aggressive fluid resuscitation resulted in a higher rate of fluid overload (20.5 versus 6.3 per cent, P=0.004), with no improvement in clinical outcomes.

Comment: Too much fluid.

Analatos A, Linblad M, Ansorge C, Lundell L, Thorell A, Hakanson BS.

BJS Open 2022; 6: zrac034.

In the study that included 70 patients, after six months, dysphagia scores were lower in the partial fundoplication group and quality of life was improved compared with total fundoplication. Radiological recurrence occurred in 47 and 46 per cent of patients, respectively.

Comment: Recurrence rates seem high in both groups, but the partial procedure seems superior.

Analatos A, Hakanson BS, Ansorge C, Lindblad M, Lundell L, Thorell A.

JAMA Surg 2022; 157: 473-480.

Some 310 patients (76 per cent of the original cohort) were available for study after over 15 years. Both procedures were equally effective at controlling reflux in the long term. Symptoms of reflux and dysphagia were similar in the two groups.

Comment: Both procedures effective.

PARANOIA Study Group.

Br J Surg 2022; 109: 812–821.

This paper included 55 studies concerning 7512 patients. Most studies were small and underpowered. External drainage, Ulinastatin treatment, and invagination pancreaticojejunostomy were associated with reduced rates of clinical postoperative pancreatic fistula.

Comment: The authors conclude bigger studies needed, but several therapies are worthwhile.

Salminen P, Gronroos S, Helmio M, Hurme S, Juuti A, Juusela R et al.

JAMA Surg 2022; 157: 656-666.

Some 193 patients were available for study after 10 years. Both procedures achieved good sustainable weight loss. Mean excess weight-loss was 8.4 per cent greater after gastric bypass; reflux oesophagitis was more common after sleeve gastrectomy.

Comment: Both procedures effective in the long term, with slightly different risk profiles.

Dayyeh PKA, Bazerbachi F, Vargas EJ, Sharaiha RZ, Thompson CC, Thaemert BC et al, for the MERIT Study Group.

Lancet 2022; 400: 441-451.

After one year, mean percentage excess weight loss was 49.2 per cent after sleeve gastrectomy compared to 3.2 per cent in controls, P<0.0001, in this study that included 209 patients. There were only three serious adverse events (2 per cent) after surgery.

Comment: Strong evidence for benefit from sleeve gastrectomy in the short term.

Suragul W, Tantawanit A, Rungsakulkji N, Muangkaew P, Tangtawee P, Mingphrudhi S et al.

BJS Open 2022; 6: zrac066.

The analysis included 150 patients in three groups. Pain scores were similar 2h after surgery. Opiate use in the first 24h was lower in patients who had a rectus sheath block compared to subcutaneous, or no infiltration (P=.043).

Comment: Small study but intramuscular infiltration seems important.

Hosoi T, Abe T, Higaki E, Fujieda H, Nagao T, Ito S, et al.

Ann Surg 2022; 276: 30-37.

In this study of 100 oesophagectomies, the rate of postoperative anastomotic stricture was 42 per cent after stapled and none after the Collard technique. Anastomotic leak rates were similar. Quality of life domains concerning swallowing were also significantly better after three months.

Comment: Should this be the standard of care?

Salminen P, Sippola S, Haijanen J, Nordström P, Rantanen T, Rautio T et al. 

Br J Surg 2022: 109: 503-509.

Seventy-two patients with CT confirmed uncomplicated appendicitis for non operative treatment were included.  The ten day successful treatment rate was 87 per cent with placebo and 97 per cent with antibiotics, (P=n.s)

Comment: So how would a surgeon  today choose to be treated if they had uncomplicated appendicitis?

Yang Y, Li B, Yi J, Hua R, Chen H, Tan L et al.

Ann Surg 2022; 275: 646-653.

Early results of this study suggest the robotic approach was quicker: 203.8 versus 244.9 minutes, P<0.001. Lymph node dissection was improved but all other clinical comparators and complication rates were similar.

Comment: modest improvement in dissection and duration of surgery, but the key is longer term outcomes.

Ruban A, Miras AD, Glaysher M, Goldstone AP, Prechtl CG, Johnson N et al.

Ann Surg 2022; 275: 440-447.

The liner was used for 12 months in this study that included 170 adults with diabetes. Use of the liner reduced glycated haemoglobin by >20 per cent in 54.6 per cent compared to 55.2 per cent in controls (P=0.85).

Comment: Although the liner did have some positive benefits, it failed to improve glycaemic control.

Doki Y, Ajani JA, Kato K, Xu J, Wyrwicz J, Motoyama S et al, for the CheckMate 648 Trial Investigators.
N Engl J Med 2022; 386: 449-462.

A total of 970 patients with advanced oesophageal cancer were studied. The addition of nivolumab with, or without ipilimumab, to standard chemotherapy improved median survival: 13.2 months nivolumab with chemotherapy; 12.7 months with additional ipilimumab; 10.7 months chemotherapy alone. Survival was improved in tumours with PD-L1 expression of one percent or greater.

Comment: Some promise for a difficult disease.

Bernardi K, Olavarria OA, Dhanani NH, Lyons N, Holihan JL, Cherla DV et al.
Ann Surgery 2022; 275: 288-294.

All obese patients with a ventral hernia were offered surgery once they had lost 7 per cent of their body weight, or had no weight gain after six months. The addition of a prehabilitation programme did not reduce the rate of perioperative complications (10.2 versus 9.1 per cent, P=0.4), or increase the number of hernia-free patients after two years: 72.9 versus 66.1 per cent, P=0.42, in this study that included 118 patients.

Comment: Either wrong programme or wrong type of patient.

Petric J, Bright T, Liu DS, Wee Yun M, Watson DI. Sutured versus mesh-augmented hiatus hernia repair.
Ann Surg 2022; 275: e45-e51.

There were seven trials including 643 procedures. Rates of recurrence after three to five years were 30.7 per cent with mesh, and 31.3 per cent with sutures. Functional outcomes and patient satisfaction were also similar.

Comment: Unlike some other hernia procedures, it seems clear here, that mesh has not been shown to be of value.

Tian Y, Cao S, Liu X, Li L, He Q, Jiang L et al.
Ann Surg 2022; 275: e15-e21.

In this study that included 400 patients, ERAS reduced hospital stay (P<0.001), speeded recovery, and were more likely to receive adjuvant chemotherapy earlier.

Comment: The benefits of a good ERAS programme are well known.

Haal S, Guman MSS, Boerlage TCC, Acherman YIZ, de Brauw LM, Bruin S et al.
Lancet Gastroenterol Hepatol 2021; 6: 993-1001.

In this trial that included 985 patients, ursodeoxycholic acid therapy did not reduce the risk of symptomatic gallstone disease: relative risk 0.67, 95 per cent confidence interval 0.43 to 1.04, P=0.071. The risk was reduced in patients without gallstones at baseline, compared to those who did.

Comment: It seems like treatment should be offered selectively.

Barham KAD, Maselli DB, Rapaka B, Lavin T, Noar M, Hussan H et al.
Lancet 2021; 398: 1965-1973.

This multicentre study included 288 patients randomized to lifestyle intervention with additional intragastric balloon therapy. After 32 weeks, mean total bodyweight loss was greater in the balloon group: 15 versus 3.3 per cent (P,0.0001). Some 17 per cent of balloons were removed for intolerance.

Comment: This is now an old technology that has never really taken off.