NIHR DC Discover

NIHR Signal Suction drainage after rectal cancer surgery does not reduce infection

Published on 28 February 2017

doi: 10.3310/signal-000389

Placing a suction drain in the pelvic cavity does not reduce the risk of pelvic infection after commonly-used surgery for rectal cancer. A French trial comparing results of surgery with and without pelvic drainage showed no difference in risk of infection within 30 days. The risk of infection was about 17%. The drainage technique is less commonly used in the UK.

The study was carried out in several hospitals and included 469 people having total mesorectal excision of rectal cancer. Half the patients were randomised to suction drainage. Surgical techniques included laparoscopic and open surgery, with staples or stitches.

Patients were followed up for signs of pelvic infection, leakage from the join in the rectum, pelvic abscess or peritonitis (inflammation of the lining of the abdomen).

Until now there’s been little good quality evidence to show whether adding a pelvic drain is helpful with this type of surgery. This study suggests no benefit from routine suction drainage.

Share your views on the research.

Why was this study needed?

Total mesorectal excision (TME) is a widely-used treatment for the 12,300 people diagnosed with rectal cancer in the UK each year. The procedure is designed to remove cancer but preserve the anal sphincter, meaning that people may not have to rely on a colostomy pouch for passing stools.

A major risk of this surgery for rectal cancer is leakage from the join (called the anastomosis) between the colon and the remains of the rectum after surgery. Leakage of fecal matter or bacteria can cause pelvic infection.

Some surgeons believe that inserting a drain at the site of the anastomosis helps avoid leakage. However, Cochrane reviewers have previously described evidence for this as low quality and insufficient to recommend the procedure. The aim of this study was to find out whether inserting a suction drain during TME for rectal cancer reduces the chances of pelvic infection within 30 days of the operation.

What did this study do?

In this randomised controlled trial (GRECCAR 5), researchers recruited 469 people having rectal surgery to remove cancer. Half were randomly allocated to have a peritoneal drain inserted during surgery and half were allocated to surgery without a drain.

Patients were checked for signs of pelvic infection for 30 days after the operation. The definition included leakage from the anastomosis, abscess in the pelvis, or peritonitis.

This prospective trial is the largest to assess the effectiveness of a suction drain in TME, and should provide good quality evidence. It was performed across multiple centres in France which reduces bias of individual surgical expertise and increases its reliability. However, surgeons undertook the randomisation, which is not ideal. The results might be less relevant in the UK as there are likely to be differences in the techniques and protocols used in France.

What did it find?

Surgical technique varied; 30 had open surgery and 439 laparoscopic surgery; 252 had their anastomosis stapled and 217 had it manually stitched. The technique did not appear to affect the likelihood of sepsis in this study.

  • Pelvic drainage did not reduce the numbers of patients who had pelvic infection within 30 days of the operation (odds ratio 0.87, 95% confidence interval 0.54 to 1.41).
  • Thirty eight (16.1%) of 236 patients who had a drain had pelvic infection, and 42 (18%) of 233 patients who did not have a drain had infection. The difference was too small to be statistically significant (p=0.58). More patients overall had sepsis than the researchers expected. From previous trials they estimated 12% would have sepsis, but in this study 17% of all patients had sepsis, which by UK standards is also high.
  • There was no difference between the groups for secondary outcomes including risk of death, reoperation, and closure of the anastomosis or length of hospital stay.

What does current guidance say on this issue?

While both the NICEScottish Intercollegiate Guidelines Network

Guidelines issued in 2007 by the Association of Coloproctology of Great Britain and Northern Ireland state: “Cochrane reviews have shown no difference in leak rates in patients where bowel preparation has been omitted and whose anastomoses have not been drained” and make no recommendation for drainage.

What are the implications?

Colorectal surgeons have had little good evidence on which to base decisions about insertion of a pelvic suction drain during TME surgery. This study was powered to show a superiority of 10% if one existed, and provides good evidence that there is no good reason to add suction drainage to the usual TME procedure.

Other types of non-suction drainage exist and these were not tested here. The authors also recommend that there are still situations where suction drains could be useful, such as where there has been bleeding during the operation.

Whilst uncertainty persists and where rates of infection remain high, attention could be given to ways of improving surgical techniques to minimise leakage.

Citation and Funding

Denost Q, Rouanet P, Faucheron JL, et al; French Research Group of Rectal Cancer Surgery (GRECCAR). To drain or not to drain infraperitoneal anastomosis after rectal excision for cancer: The GRECCAR 5 randomized trial. Ann Surg. 2017;265(3):474-80.

No funding information was provided for this study.

Bibliography

Association of Colproctology of Great Britain and Northern Ireland. Guidelines for the Management of Colorectal Cancer . London: 2007.

NICE. Transanal total mesorectal excision of the rectum. IPG514. London: National Institute for Health and Care Excellence; 2015.

Rolph R, Duffy  J MN, Alagaratnam S, et al. Intra-abdominal drains for the prophylaxis of anastomotic leak in elective colorectal surgery. Cochrane Database Syst Rev. 2004;(4):CD002100 .

SIGN. Diagnosis and management of colorectal cancer. 126. Edinburgh: Scottish Intercollegiate Guidelines Network; 2011.

Why was this study needed?

Total mesorectal excision (TME) is a widely-used treatment for the 12,300 people diagnosed with rectal cancer in the UK each year. The procedure is designed to remove cancer but preserve the anal sphincter, meaning that people may not have to rely on a colostomy pouch for passing stools.

A major risk of this surgery for rectal cancer is leakage from the join (called the anastomosis) between the colon and the remains of the rectum after surgery. Leakage of fecal matter or bacteria can cause pelvic infection.

Some surgeons believe that inserting a drain at the site of the anastomosis helps avoid leakage. However, Cochrane reviewers have previously described evidence for this as low quality and insufficient to recommend the procedure. The aim of this study was to find out whether inserting a suction drain during TME for rectal cancer reduces the chances of pelvic infection within 30 days of the operation.

What did this study do?

In this randomised controlled trial (GRECCAR 5), researchers recruited 469 people having rectal surgery to remove cancer. Half were randomly allocated to have a peritoneal drain inserted during surgery and half were allocated to surgery without a drain.

Patients were checked for signs of pelvic infection for 30 days after the operation. The definition included leakage from the anastomosis, abscess in the pelvis, or peritonitis.

This prospective trial is the largest to assess the effectiveness of a suction drain in TME, and should provide good quality evidence. It was performed across multiple centres in France which reduces bias of individual surgical expertise and increases its reliability. However, surgeons undertook the randomisation, which is not ideal. The results might be less relevant in the UK as there are likely to be differences in the techniques and protocols used in France.

What did it find?

Surgical technique varied; 30 had open surgery and 439 laparoscopic surgery; 252 had their anastomosis stapled and 217 had it manually stitched. The technique did not appear to affect the likelihood of sepsis in this study.

  • Pelvic drainage did not reduce the numbers of patients who had pelvic infection within 30 days of the operation (odds ratio 0.87, 95% confidence interval 0.54 to 1.41).
  • Thirty eight (16.1%) of 236 patients who had a drain had pelvic infection, and 42 (18%) of 233 patients who did not have a drain had infection. The difference was too small to be statistically significant (p=0.58). More patients overall had sepsis than the researchers expected. From previous trials they estimated 12% would have sepsis, but in this study 17% of all patients had sepsis, which by UK standards is also high.
  • There was no difference between the groups for secondary outcomes including risk of death, reoperation, and closure of the anastomosis or length of hospital stay.

What does current guidance say on this issue?

While both the NICEScottish Intercollegiate Guidelines Network

Guidelines issued in 2007 by the Association of Coloproctology of Great Britain and Northern Ireland state: “Cochrane reviews have shown no difference in leak rates in patients where bowel preparation has been omitted and whose anastomoses have not been drained” and make no recommendation for drainage.

What are the implications?

Colorectal surgeons have had little good evidence on which to base decisions about insertion of a pelvic suction drain during TME surgery. This study was powered to show a superiority of 10% if one existed, and provides good evidence that there is no good reason to add suction drainage to the usual TME procedure.

Other types of non-suction drainage exist and these were not tested here. The authors also recommend that there are still situations where suction drains could be useful, such as where there has been bleeding during the operation.

Whilst uncertainty persists and where rates of infection remain high, attention could be given to ways of improving surgical techniques to minimise leakage.

Citation and Funding

Denost Q, Rouanet P, Faucheron JL, et al; French Research Group of Rectal Cancer Surgery (GRECCAR). To drain or not to drain infraperitoneal anastomosis after rectal excision for cancer: The GRECCAR 5 randomized trial. Ann Surg. 2017;265(3):474-80.

No funding information was provided for this study.

Bibliography

Association of Colproctology of Great Britain and Northern Ireland. Guidelines for the Management of Colorectal Cancer . London: 2007.

NICE. Transanal total mesorectal excision of the rectum. IPG514. London: National Institute for Health and Care Excellence; 2015.

Rolph R, Duffy  J MN, Alagaratnam S, et al. Intra-abdominal drains for the prophylaxis of anastomotic leak in elective colorectal surgery. Cochrane Database Syst Rev. 2004;(4):CD002100 .

SIGN. Diagnosis and management of colorectal cancer. 126. Edinburgh: Scottish Intercollegiate Guidelines Network; 2011.

To Drain or Not to Drain Infraperitoneal Anastomosis After Rectal Excision for Cancer: The GRECCAR 5 Randomized Trial

Published on 16 September 2016

Denost, Q.,Rouanet, P.,Faucheron, J. L.,Panis, Y.,Meunier, B.,Cotte, E.,Meurette, G.,Kirzin, S.,Sabbagh, C.,Loriau, J.,Benoist, S.,Mariette, C.,Sielezneff, I.,Lelong, B.,Mauvais, F.,Romain, B.,Barussaud, M. L.,Germain, C.,Picat, M. Q.,Rullier, E.,Laurent, C.

Ann Surg , 2016

OBJECTIVE: To assess the effect of pelvic drainage after rectal surgery for cancer. BACKGROUND: Pelvic sepsis is one of the major complications after rectal excision for rectal cancer. Although many studies have confirmed infectiveness of drainage after colectomy, there is still a controversy after rectal surgery. METHODS: This multicenter randomized trial with 2 parallel arms (drain vs no drain) was performed between 2011 and 2014. Primary endpoint was postoperative pelvic sepsis within 30 postoperative days, including anastomotic leakage, pelvic abscess, and peritonitis. Secondary endpoints were overall morbidity and mortality, rate of reoperation, length of hospital stay, and rate of stoma closure at 6 months. RESULTS: A total of 494 patients were randomized, 25 did not meet the criteria and 469 were analyzed: 236 with drain and 233 without. The anastomotic height was 3.5 +/- 1.9 cm from the anal verge. The rate of pelvic sepsis was 17.1% (80/469) and was similar between drain and no drain: 16.1% versus 18.0% (P = 0.58). There was no difference of surgical morbidity (18.7% vs 25.3%; P = 0.83), rate of reoperation (16.6% vs 21.0%; P = 0.22), length of hospital stay (12.2 vs 12.2; P = 0.99) and rate of stoma closure (80.1% vs 77.3%; P = 0.53) between groups. Absence of colonic pouch was the only independent factor of pelvic sepsis (odds ratio = 1.757; 95% confidence interval 1.078-2.864; P = 0.024). CONCLUSIONS: This randomized trial suggests that the use of a pelvic drain after rectal excision for rectal cancer did not confer any benefit to the patient.

Total mesorectal excision involves removal of the length of rectum containing cancerous tissue, plus the fatty tissue (mesorectum) around the rectum itself. If long enough, the remaining part of the rectum is repaired by joining it to the colon in a join called an anastomosis. This means the patient can retain the anal sphincter muscle, so that after healing, they should be able to pass stools normally. The operation can be carried out via open or laparoscopic surgery.

Expert commentary

This study suggests that placing a suction drain at the time of rectal cancer surgery is unnecessary. However, no conclusions may be inferred for the benefits of non-suction drains, which are more commonly used by UK Surgeons. The French predisposition for short course radiotherapy, hand sewn anastomoses and suction drains may affect the high reported leak rates in this study. These do not closely enough reflect UK practice for this single study to influence the placement of pelvic drains. Whilst controversy regarding this multifactorial problem still exists the surgeon’s preference should still prevail.

Mr Guy F Nash, Associate Professor & Consultant Colorectal Surgeon