Randomized clinical trials

De Wijkerslooth EML, Boerma E-JG, van Rossem CC, van Rosmalen J, Baeten CIM, Beverdam FH et al, for the APPIC Study Group.

Lancet 2023; 401: 366-376.

Some 1066 patients were included; 95% had a laparoscopic appendicectomy. The rate of postoperative infection or death within 90 days was similar after two (10 per cent) and five days of antibiotics (8 per cent; risk difference 2 per cent, 95 per cent confidence interval-1.6 to 5.6 per cent). Readmission to hospital was more common after the two day course: 12 versus 6 per cent).

Comment: Very useful pragmatic trial that will assist decisions made in all acute hospitals, and significantly reduce antibiotic use.

Bretthauer M, Loberg M, Wieszcy P, Kalager M, Emilsson L, Garborg K et al, for the NordICC Study Group.

N Engl J Med 2022; 387: 1547-1556.

This study included over 84,000 people aged 55 to 64. A single colonoscopy reduced the risk of colorectal cancer by 18% after 10 years (number needed to screen to prevent one colorectal cancer = 455). The risk of death from colorectal cancer and the overall risk of death was not significantly reduced by screening.

Comment: As is so often the case with screening programmes, they can be shown to reduce the rate of the specific condition, but not mortality.

Newton K, Dumville J, Briggs M, Law J, Martin J, Pearce L et al, for the PPAC2 Collaborators.

Br J Surg 2022; 109: 951–957.

Packing increased postoperative pain scores (P<0.0001) in this study that included 433 procedures, without increasing the risk of recurrent abscess: 6 versus 3 per cent, P=0.2.

Comment: Simple study with an important message.

Lanenbach MR, Florescu R-V, Kohler A, Barkus J, Ritx  J-P, Quemalli E et al.

BJS Open 2022; 6: zrac070.

A tamponade dressing increased postoperative pain, without reducing the rate of severe bleeding (five in each group), in this study that included 754 procedures.

Comment: Another longstanding practice that can be binned.

Yang H, Shi Z, Chen W, Chen T, Ding P, Wang J et al.

BJS Open 2022; 6: zrac064.

In this study that included 133 patients, the modified ligation technique took longer (mean 57 versus 31 min; P<0.001), but caused less postoperative pain, and a higher cure rate after six months (P=0.003).

Comment: A promising option.

van der Heijden JAG, Kalkdijk-Dijkstra AJ, Pierie JPEN, van Westreenen HL, Broens PMA, Klarenbeek BR, et al on behalf of the FORCE trial group.

Ann Surg 2022; 276: 38-45.

Overall, a course of pelvic floor rehabilitation did not improve continence compared to usual care (Wexner score) in this study that included 128 patients. However, several subgroups were identified that did benefit: those with urgency and moderate incontinence postoperatively.

Comment: This sounds like valuable research for patients with a troublesome problem. More research into the subgroups that may benefit is indicated.

Tie J, Cohen JD, Lahouel K, Lo SN, Wang Y, Kosmider S et al, for the DYNAMIC Investigators.

N Engl J Med 2022; 386: 2261-2272.

Patients were randomized to adjuvant chemotherapy depending on the presence of circulating DNA (n=302), or a control group (n=153). Fewer patients in the DNA group had chemotherapy (15 versus 28%), without compromising the rate of recurrence-free survival at a median of 37 months.

Comment: The optimal adjuvant treatment for surgically treated colorectal cancer continues to evolve. This study is another step forwards, and helps limit adjuvant therapy to those who will benefit most.

Milne T, Liu C, O’Grady G, Woodfield J, Bissett I. 

Br J Surg 2022; 109: 704–710.

Return of gut function was not improved by prucalopride, a serotonin agonist, 2 mg given before surgery and 2 mg daily for six days, in this study that included 148 patients.

Comment: Disappointing.

Meima-van Praag LM, van Rijn KL, Wasmann KAT, Snijder H, Stoker J, D’Haens GR et al.

Lancet Gastroenterol Hepatol 2022; 7: 617-626.

Some 95 patients were included in this trial. After 18 months, radiological (MRI) healing was higher after surgery with anti-TNF (32 per cent) than anti-TNF alone (9 per cent); P=0.005. In contrast, clinical closure rates were reported as similar: 68 versus 52 per cent, respectively.

Comment: Shouldn’t there have been a surgery only arm for the perfect trial?

Forsberg A, Westerberg M, Metcalfe C, Steele R, Blom J, Engstrand L et al.

Lancet Gastroenterol Hepatol 2022; 7: 513-521.

This study included 278,280 people. More people accepted the faecal testing than colonoscopy (55.5 versus 35.1 per cent). Similar rates of cancer were detected (0.16 and 0.2 per cent, respectively). More  advanced adenomas were detected by colonoscopy (2.05 versus 1.61 per cent, respectively).

Comment: Overall, more cancers were found by the method that was more acceptable to people. Late benefits in disease-specific mortality will be used to decide on the method of choice.

Woodfield JC, Clifford K, Schmidt B, Turner GA, Amer MA, McCall JL.
JAMA Surg 2022; 157: 34-41.

This analysis included 8377 patients from 35 RCTs. Optimal reduction in infection/dehiscence rates was achieved by a combination of oral and intravenous antibiotics, with or without cleansing with enema. The addition of oral to intravenous antibiotics reduced surgical site infection by greater than 50 per cent.

Comment: the best evidence that both oral and intravenous antibiotics should be routine.

Huang C, Liu H, Hu Y, Sun Y, Su X, Cau H et al, for the Chinese Laparoscopic Gastrointestinal Surgery Study (CLASS) Group.
JAMA Surg 2022; 157: 9-17.

The analysis included 1039 patients from multiple centres. Overall survival rates were 72.6 per cent after laparoscopic, and 76.3 per cent after open surgery (P=0.19).

Comment; No oncological disadvantage for the laparoscopic approach.

MacFater WS, Xia W, Barazanchi A, Lightfoot NJ, Weston M, Svirskis D et al.
Ann Surg 2022; 275: e30-e36.

The same dose of lidocaine was either instilled at operation or given intravenously over three days postoperatively, in this study that included 56 patients. Opioid consumption over the first three days was reduced in the group that had intraperitoneal instillation (p<0.05).

Comment; It seems the peritoneal cavity at the time of surgery is the best target for local anaesthesia.

Blok R, Sharabiany S, Stoker J, Laan ETM, Bosker RJI, Burger JWA et al.
Ann Surg 2022; 275: e37-e44.

Some 106 patients were randomized initially. After five years the rate of symptomatic recurrent perineal hernia was 7 per cent after mesh closure compared to 30 per cent after suture closure (P=0.006).

Comment: mesh seems to be valuable in the perineum.

Prudhomme, M, Rullier E, Lakkis Z, Cotte E, Panis Y et al.
Ann Surg 2021; 274: 928-934.

There was no difference in the rates of stomal hernia after 24 months in this study that finally included 135 procedures: 31 per cent versus 28 per cent without mesh. There were no mesh infections.

Comment: It is interesting that there have been numerous RCTs, but with very variable results. This makes it difficult to conduct a systematic analysis, and to provide definitive recommendations.

van der Kruijssen DEW, Elias SG, Vink GR, van Rooijen KL, Lam-Boer J, Mol L, et al for the CAIRO4 Working Group.
JAMA Surg 2021; 156: 1093-1101.

This study included 196 patients with metastatic colorectal cancer, and few or no symptoms from the primary. At 60 days, mortality rates were higher in those who had surgery as well as chemotherapy: 3 versus 11 per cent, P=0.03.

Comment: These results are of interest, but the real question is whether additional surgery provides a later benefit.

Wei B, Zheng Z, Fang J, Xiao J, Han F, Huang M et al.
Ann Surg 2021; 274: e473-e480.

Some 253 men undergoing surgery for rectal cancer were included. Fascial preservation improved both the rate of urinary dysfunction (6.8 versus 25.4 per cent, P=0.003) and erectile dysfunction 12.5 versus 34.2 per cent, P=0.023).

Comment: But will it affect cancer outcomes in the longer term?