Randomized clinical trials

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.

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.

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.

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.

Ringblom C, Odensten C, Strigård K, Gunnarsson U, Näsvall P.

Ann Surg 2023; 277: 38-42.

Some 154 patients were evaluable after three years. There was no significant difference in clinical or radiological rates of stoma hernia, or reintervention.

Comment: One of a number of similar trials, with varying results. Clearly not as definitive as for abdominal wounds.

Wan J, Wang S, Yan B, Tang Y, Zheng J, Ji H et al.

BJS Open 2022; 6: zrac151.

In this study that included 66 procedures, use of indocyanine green detected a median of two more nodes during dissection. The median number of positive nodes was similar in the two groups.

Comment: Elegant, but may not affect clinical outcomes.

Pieniowski EHA, Bergström CM, Nordenvall CAM, Westberg KS, Johar AM, Tumlin E et al.

Ann Surg 2023; 277: 30-37.

Forty-five patients were included in this study. Irrigation reduced symptom scores after 12 months (22.9 versus 32.4, P=0.002), and improved quality of life.

Comment: Daily irrigation of the rectum to keep it empty certainly helps some patients with this distressing symptom.

Serra-Aracil X, Zarate A, Bargallo J, Gonzalez A, Serracant A, Roura J et al for the Ta-LaTME study Group.

Br J Surg 2023; 110: 150–158.

This study included 105 evaluable patients. Conversion to open surgery was needed after 20 per cent of transanal, versus 2 per cent of laparoscopic procedures, P=0.003. Morbidity rates, and postoperative recovery were similar. After a median of 39 months recurrence rates were similar: 6.1 percent laparoscopic, and 1.8 per cent transanal surgery.

Comment: This is a brave study, but really too small to answer many of the questions that remain about TaTME. Longer term follow-up will be important.

Wang N, Yang J-W, Yan S-Y, Lu Y, Han J-G, Pei W et al.

JAMA Surg 2023; 158: 20-27.

This intervention was used as part of an ERAS protocol in 248 patients having laparoscopic colorectal resection. Electroacupuncture reduced the median time to first defaecation (76.4h vs. 90h in controls, P=0.003), and reduced the rate of prolonged ileus (10 vs. 20 per cent, P=0.03), with no severe adverse events.

Comment: Possibly worth trying, if these results are corroborated, and particularly if it reduces duration of hospital stay.

Herrod PJJ, Kwok AT, Lobo DN.

BJS Open 2022; 6: zrac100.

Eight RCTs including 3203 participants were analyzed. Early optimism about the benefits of antibiotic therapy were tempered in this analysis by reduced treatment efficacy compared with appendicectomy, higher readmission rate, and no advantage in duration of stay at index admission.

Comment: Antibiotic treatment for appendicitis has a place, but not as standard therapy.

Feng Q, Yuan W, Li PT, Tang B, Jia B, Zhou Y et al, for the REAL Study Group.

Some 1240 patients were included in the study, and 1171 included in the analysis. Rates of positive resection margin were: robotic 4 per cent, laparoscopic 7.2 per cent, P=0.023. Complete resection rates were similarly improved: 95.4 versus 91.8 per cent, respectively. Relative postoperative complication rates were 16.2  and 23.1 per cent, P=0.003. Hospital stay was also shorter: 7 versus 8 days, P=0.0001.

Comment: The first real evidence that the robot beats the laparoscope. But what are the long term results, and are the benefits worth the increased costs?

Asnong A, D’Hoore A, Van Kampen M, Wolthuis A, Van Molhem Y, Van Geluwe B et al.

Ann Surg 2022; 276: 761-768.

Training for one month after stoma closure improved symptoms after six months (low anterior resection symptom category): 47.8 versus 21.3 per cent, P=0.0091, in this study that included 104 patients. This improvement was lost after one year.

Comment: Improves short term recovery, but questionable efficacy in the longer term.

Ruiz-Tovar J, Llavero C.

Dis Colon Rectum 2022; 65: 406-412.

Use of tocopherol ointment improved pain scores after eight weeks (P=0.018) in this study that included 160 patients. It also reduced recurrence rates after 16 weeks: 2.9 versus 13.2 per cent, P=0.031.

Comment: Worth more trials?

Jin JZ, Bhat S, Park B, Hardy M-H, UnasaH, Mauiliu-Wallis M et al.

Surgery 2022; 172: 41-52.

Sixty-nine RCTs were included. Botulinum toxin was shown to be similarly effective to other medical treatments for initial care. Surgical lateral sphincterotomy had the highest healing rate and was considered definitive after failed medical treatment.

Comment; Clear evidence-based advice.

Akgun E, Caliskan C, Bozbiyik O, Yoldas T, Doganavasargil B, Ozkok S et al.

BJS Open 2022; 6: zrac107.

Although locoregional recurrence was higher at five years (10.1 per cent if over 8 weeks after chemotherapy versus 6.9 per cent if less than 8 weeks, P=0.14), disease-free and overall survival were similar in this study that included 350 patients.

Comment: Remains controversial, but no clear evidence here that waiting for surgery is detrimental.

Fahim M, Couwenberg A, Verweij ME, Dijksman LM, Verkooijen HM, Smits AB.

Br J Surg 2022; 109: 1081-1086.

Some 163 patients were included in the study. Using the sponge to avoid the Trendelenburg (head down) position did not affect postoperative complications or hospital stay. There were no adverse events from the sponge.

Comment: Not worth the investment, unless perhaps it is expected the procedure will be prolonged.

Dohrn N, Yikilmaz H, Laursen M, Khesrawi F, Clausen FB, Sørensen F et al.

Ann Surg 2022; 276: e294-e301.

There was no difference in any of the outcome parameters in this study that included 89 procedures, except that intracorporeal anastomosis took longer to perform 17 vs 13 min, P=0.003.

Comment: Why make the procedure more difficult?

CReST Collaborative Group.

Br J Surg 2022; 109: 1073-1080.

Stenting relieved the obstruction in 82 per cent in this study that included 245 patients. Thirty day outcomes were similar, but stented patients were less likely to need a stoma: 47 versus 68 per cent, P=0.003.

Comment: This is a good study, and an important result, given the difficulties of managing even a temporary stoma.

HART Collaborative.

Br J Surg 2022; 109: 943–950.

This study that included 802 procedures showed that the risk of postoperative incisional hernia was high. After two years there was no difference in the rate of incisional hernia after Hughes repair compared to standard mass closure: 28.7 versus 31.8 per cent, P=0.429.

Comment: Ways to reduce incisional hernia are still needed.

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.

Takii Y, Mizusawa J, Kanemitsu Y, Komori K, Shiozawa M, Ohue M et al.

Ann Surg 2022; 275: 849-855.

Use of the no touch technique during colon cancer resection failed to improve three year disease-free survival in this multicentre study that included 853 procedures: hazard ratio 1.03, 95 per cent confidence interval 0.8 to 1.3, P=0.59.

Comment: Perhaps other factors are just more important.

Onerup A, Andersson J, Angenete E, Bock D, Börjesson M, Ehrencrona C et al.

Ann Surg 2022; 275: 448-455.

The intervention was physical activity for two weeks before and four weeks after surgery. After four weeks there was no demonstrable improvement in recovery in this study that included 761 randomized patients.

Comment: this model of prehabilitation was not effective in this patient group.

Smedberg J, Graf W, Pekkari K, Hjern F.

BJS Open 2022; zrab140.

A total of 122 patients were available for analysis. All the different procedures improved quality of life, with similar rates of complications. Recurrence rates were higher than expected for all procedures.

Comment: Probably too few patients to make fair comparison, but worrying recurrence rates.

Gupta S, Sidhu M, Shahidi N, Vosko S, McKay O, Bahin FF et al.
Lancet Gastroenterol Hepatol 2022; 7: 152-160.

Some 231 patients with a pedunculated colonic polyp were randomly allocated to a clip on the stalk after endoscopic mucosal resection. Clip application reduced the rate of clinically significant bleeding: 3.4 versus 10.6 per cent; P=0.031.

Comment: Makes sense, but how much are the clips and how bad was the bleeding?

Berkel AEM, Bongers BC, Kotte H, Weltevreden P, de Jongh FHC, Eijsvogel MMM et al.
Ann Surg 2022; 275: e299-e306.

Effects of community-based exercise prehabilitation for patients scheduled for colorectal surgery with high risk for postoperative complications: results of a randomized clinical trial.

Comment: Small study, but promising result. If proven in a larger trial, community-based prehabilitation makes a lot of sense.

Planellas P, Marinello F, Elorza G, Golda T, Farrés R, Espín-Basany E et al.
Ann Surg 2022; 275: 271-280.

Extending the mesocolic excision to include the tissue around the inferior mesenteric vein did not increase the lymph node yield (21 versus 20 nodes) in this study that included 91 procedures. It did adversely affect genitourinary function; P=0.026.

Comment: No more nodes harvested, some damage done, and the study is too small to compare clinical outcomes.